A Phase 3, Randomized, Double-blind, Placebo-controlled Study of Gemcitabine and Nab-paclitaxel Combined With Momelotinib in Subjects With Previously Untreated Metastatic Pancreatic Ductal Adenocarcinoma Preceded by a Dose-finding, Lead-in Phase
Phase: PHASE3
Conditions: Metastatic Pancreatic Ductal Adenocarcinoma
Sponsor: Sierra Oncology LLC - a GSK company

Study Title: 
Sponsor: 
IND Number: 
Indication: 
Protocol ID: 
Clinical Program 
Manager: 
Gilead Medical 
Monitor: 
Protocol Version/Date: 
(!') GILEAU 
CLINICAL STUDY PROTOCOL 
A Phase 2, Randomized, Double-blind Study of Gemcitabine and 
Nab-paclitaxel combined with Momelotinib in Subjects with 
Previously Untreated Metastatic Pancreatic Ductal 
Adenocarcinoma Preceded by a Dose-finding, Lead-in Phase 
Gilead Sciences, Inc. 
333 Lakeside Drive 
Foster City, CA 94404 
101155 
Previously untreated locally advanced or metastatic pancreatic 
ductal adenocarcinoma 
GS-US-370-1296 
Name: 
PPD 
Telephone: 
PPD 
Name: 
Peter Lee, MD, PhD 
Telephone: 
PPD 
Original: 
11 Febmmy 2014 
CONFIDENTIALITY STATEMENT 
The inf01mation contained in this document, pmi iculm·ly unpublished data, is the prope1iy or 
under control of Gilead Sciences, Inc., and is provided to you in confidence as an investigator, 
potential investigator, or consultant, for review by you, your staff, and an applicable Institutional 
Review Board or Independent Ethics Committee. The infonnation is only to be used by you in 
connection with authorized clinical studies of the investigational dmg described in the protocol. 
You will not disclose any of the infonnation to others without written authorization from 
Gilead Sciences, Inc., except to the extent necessa1y to obtain infonned consent from those 
persons to whom the dmg may be administered. 

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TABLE OF CONTENTS
TABLE OF CONTENTS ..............................................................................................................................................2
LIST OF IN-TEXT TABLES........................................................................................................................................5
PROTOCOL SYNOPSIS ..............................................................................................................................................6
GLOSSARY OF ABBREVIATIONS AND DEFINITION OF TERMS....................................................................16
1.
INTRODUCTION ..............................................................................................................................................20
1.1.
Background ............................................................................................................................................20
1.2.
Momelotinib (MMB) .............................................................................................................................20
1.2.1.
General Information .............................................................................................................20
1.2.2.
Nonclinical Pharmacology and Toxicology .........................................................................21
1.2.3.
Clinical Trials of Momelotinib.............................................................................................24
1.3.
Anticipated Risk.....................................................................................................................................24
1.4.
Rationale for This Study ........................................................................................................................25
1.5.
Compliance ............................................................................................................................................26
2.
OBJECTIVES.....................................................................................................................................................27
3.
STUDY DESIGN................................................................................................................................................28
3.1.
Study Design..........................................................................................................................................28
3.2.
Study Treatments ...................................................................................................................................30
3.3.
Duration of Treatment............................................................................................................................30
3.4.
Discontinuation Criteria.........................................................................................................................30
3.5.
Source Data............................................................................................................................................30
3.6.
Biomarker Testing..................................................................................................................................30
3.6.1.
Biomarker Samples to Address the Study Objectives ..........................................................30
3.6.2.
Biomarker Samples for Optional Future Research...............................................................32
3.6.3.
Biomarker Samples for Optional Pharmacogenomic Research............................................33
4.
SUBJECT POPULATION..................................................................................................................................34
4.1.
Number of Subjects and Subject Selection ............................................................................................34
4.2.
Inclusion Criteria....................................................................................................................................34
4.3.
Exclusion Criteria...................................................................................................................................35
5.
INVESTIGATIONAL PRODUCTS...................................................................................................................37
5.1.
Randomization, Blinding and Treatment Codes ....................................................................................37
5.2.
Description and Handling of MMB........................................................................................................37
5.2.1.
Formulation..........................................................................................................................37
5.2.2.
Packaging and Labeling .......................................................................................................37
5.2.3.
Storage and Handling...........................................................................................................38
5.3.
Dosage and Administration....................................................................................................................38
5.3.1.
MMB and Placebo................................................................................................................38
5.3.2.
Nab-paclitaxel and Gemcitabine ..........................................................................................38
5.4.
Dose Adjustment of Nab-Paclitaxel and Gemcitabine...........................................................................39
5.5.
Dose Adjustment of MMB.....................................................................................................................40
5.6.
Restricted/Prohibited Medications .........................................................................................................41
5.7.
Accountability for MMB or Placebo......................................................................................................42
5.7.1.
Investigational Medicinal Product Return or Disposal.........................................................42
6.
STUDY PROCEDURES ....................................................................................................................................43
6.1.
Subject Enrollment and Treatment Assignment.....................................................................................43
6.2.
Description of Study Procedures............................................................................................................43

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6.2.1.
Informed Consent.................................................................................................................43
6.2.2.
Medical History....................................................................................................................43
6.2.3.
Prior/Concomitant Medications............................................................................................44
6.2.4.
Physical Examination...........................................................................................................44
6.2.5.
Vital Signs............................................................................................................................44
6.2.6.
Electrocardiogram................................................................................................................44
6.2.7.
Laboratory Assessments.......................................................................................................44
6.2.8.
Patient-Reported Outcomes Assessments (PRO).................................................................46
6.2.9.
Disease Assessments............................................................................................................47
6.3.
Pretreatment Assessments......................................................................................................................47
6.3.1.
Screening Visit .....................................................................................................................47
6.3.2.
Subject Randomization.........................................................................................................48
6.3.3.
Baseline Visit / C1D1...........................................................................................................49
6.4.
Treatment Assessments..........................................................................................................................50
6.4.1.
Days 1 of Subsequent Cycles, Days 8 and 15 ......................................................................50
6.4.2.
End of Treatment (EOT) Visit..............................................................................................51
6.5.
Unscheduled visits .................................................................................................................................52
6.6.
Post-treatment Follow-up Assessments..................................................................................................52
6.6.1.
30-Day Safety Follow-up Visit ............................................................................................52
6.6.2.
5-Year Long Term Survival Follow-Up...............................................................................53
6.7.
Withdrawal from Treatment, Procedures, and Study .............................................................................53
6.7.1.
Subjects’ Decision to Withdraw...........................................................................................53
6.7.2.
Investigator or Sponsor Decision to Withdraw or Terminate Subjects’ 
Participation Prior to Study Completion ..............................................................................53
6.8.
Criteria for Discontinuation from Treatment or Study...........................................................................54
6.8.1.
Criteria for Discontinuation from Treatment........................................................................54
6.8.2.
Criteria for Discontinuation from Study...............................................................................55
6.9.
Protocol Deviations................................................................................................................................55
6.10.
End of Study...........................................................................................................................................55
7.
ADVERSE EVENTS AND TOXICITY MANAGEMENT...............................................................................56
7.1.
Definitions of Adverse Events, Adverse Reactions, and Serious Adverse Events.................................56
7.1.1.
Adverse Events.....................................................................................................................56
7.1.2.
Serious Adverse Events........................................................................................................56
7.1.3.
Clinical Laboratory Abnormalities and Other Abnormal Assessments as 
Adverse Events or Serious Adverse Events .........................................................................57
7.2.
Assessment of Adverse Events and Serious Adverse Events.................................................................58
7.2.1.
Assessment of Causality for Study Drugs and Procedures...................................................58
7.2.2.
Assessment of Severity ........................................................................................................58
7.3.
Investigator Requirements and Instructions for Reporting Adverse Events and Serious 
Adverse Events to Gilead or CRO .........................................................................................................59
7.4.
Gilead Reporting Requirements.............................................................................................................60
7.5.
Clinical Laboratory Abnormalities and Other Abnormal Assessments as Adverse Events or 
Serious Adverse Events..........................................................................................................................61
7.6.
Toxicity Management ............................................................................................................................61
7.7.
Special Situations Reports......................................................................................................................61
7.7.1.
Definitions of Special Situations..........................................................................................61
7.7.2.
Instructions for Reporting Special Situations.......................................................................62
8.
STATISTICAL CONSIDERATIONS................................................................................................................64
8.1.
Analysis Objectives and Endpoints........................................................................................................64
8.1.1.
Analysis Objectives..............................................................................................................64
8.1.2.
Primary Endpoint .................................................................................................................64
8.1.3.
Secondary Endpoint .............................................................................................................64

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8.1.4.
Exploratory Endpoints..........................................................................................................65
8.2.
Analysis Conventions.............................................................................................................................66
8.2.1.
Analysis Sets ........................................................................................................................66
8.3.
Data Handling Conventions ...................................................................................................................66
8.4.
Demographic Data and Baseline Characteristics ...................................................................................68
8.5.
Efficacy Analysis ...................................................................................................................................68
8.5.1.
Primary Analysis..................................................................................................................68
8.5.2.
Other Time-to-Event Endpoints ...........................................................................................68
8.5.3.
Categorical Endpoints ..........................................................................................................68
8.5.4.
Continuous Endpoints ..........................................................................................................69
8.5.5.
Control of Type I Error Rate in Efficacy Analyses ..............................................................69
8.6.
Safety Analysis.......................................................................................................................................69
8.6.1.
Extent of Exposure...............................................................................................................69
8.6.2.
Adverse Events.....................................................................................................................69
8.6.3.
Laboratory Evaluations ........................................................................................................70
8.7.
Pharmacokinetic Analysis......................................................................................................................71
8.8.
Biomarker Analysis................................................................................................................................71
8.8.1.
Pharmacodynamic Analysis .................................................................................................71
8.8.2.
Exploratory Biomarker Analysis..........................................................................................71
8.9.
Sample Size............................................................................................................................................71
8.10.
Interim Analysis.....................................................................................................................................72
8.11.
Data Monitoring Committee ..................................................................................................................72
9.
RESPONSIBILITIES..........................................................................................................................................73
9.1.
Investigator Responsibilities ..................................................................................................................73
9.1.1.
Good Clinical Practice..........................................................................................................73
9.1.2.
Institutional Review Board (IRB)/Independent Ethics Committee (IEC) 
Review and Approval...........................................................................................................73
9.1.3.
Informed Consent.................................................................................................................74
9.1.4.
Confidentiality......................................................................................................................74
9.1.5.
Study Files and Retention of Records ..................................................................................74
9.1.6.
Case Report Forms...............................................................................................................76
9.1.7.
Investigational Product Accountability and Return..............................................................76
9.1.8.
Inspections............................................................................................................................76
9.1.9.
Protocol Compliance............................................................................................................76
9.2.
Sponsor Responsibilities ........................................................................................................................77
9.2.1.
Protocol Modifications.........................................................................................................77
9.2.2.
Study Report and Publications .............................................................................................77
9.3.
Joint Investigator/Sponsor Responsibilities ...........................................................................................77
9.3.1.
Payment Reporting...............................................................................................................77
9.3.2.
Access to Information for Monitoring..................................................................................78
9.3.3.
Access to Information for Auditing or Inspections ..............................................................78
9.3.4.
Study Discontinuation..........................................................................................................78
10.
REFERENCES ...................................................................................................................................................79
11.
APPENDICES ....................................................................................................................................................81
Appendix 1.
Investigator Signature Page....................................................................................................82
Appendix 2.
Study Procedures Table..........................................................................................................83
Appendix 3.
Pregnancy Precautions, Definition for Female of Childbearing Potential, and 
Contraceptive Requirements...................................................................................................86
Appendix 4.
ECOG Performance Status.....................................................................................................88
Appendix 5.
Dose-Escalation Flowchart- Lead-in Phase............................................................................89

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LIST OF IN-TEXT TABLES
Table 3-1.
Dose Escalation Scheme.........................................................................................................28
Table 5-1.
Dose Reduction of Nab-Paclitaxel and Gemcitabine .............................................................39
Table 5-2.
Dose Modification of Nab-Paclitaxel and Gemcitabine for Neutropenia and/or 
Thrombocytopenia at Start of a Cycle or Within a Cycle.......................................................39
Table 5-3.
Dose Modification of Nab-Paclitaxel and Gemcitabine for Other Adverse Drug 
Reactions ................................................................................................................................39
Table 5-4.
MMB Dose Reduction for Thrombocytopenia.......................................................................40
Table 5-5.
Restarting Doses of MMB After Treatment Interruption .......................................................40
Table 6-1.
Analytes..................................................................................................................................45
Table 7-1.
Grading of Adverse Event Severity........................................................................................59
Table 8-1.
Boundary-Crossing Probabilities at Interim and Final Analyses Based on the 
Assumptions of the Study.......................................................................................................72

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PROTOCOL SYNOPSIS
Gilead Sciences, Inc.
333 Lakeside Drive
Foster City, CA, 94404
Study Title: 
A Phase 2, Randomized, Double-blind Study of Gemcitabine and Nab-
paclitaxel combined with Momelotinib in Subjects with Previously 
Untreated Metastatic Pancreatic Ductal Adenocarcinoma Preceded by 
a Dose-finding, Lead-in Phase
IND Number:
101155
Study Centers 
Planned:
Lead-in phase: Approximately 2-3 centers in the United States 
Randomized treatment phase: Approximately 75 centers worldwide 
Objectives:
Primary Objectives:

Lead-in phase: To evaluate the safety, pharmacokinetics, and 
define the maximum tolerated dose (MTD) of momelotinib 
(MMB) combined with gemcitabine/nab-paclitaxel (nab-P+G) in 
subjects with previously untreated metastatic pancreatic ductal 
adenocarcinoma.

Randomized treatment phase: To determine the efficacy of nab-
P+G combined with either MMB administered at the MTD or 
placebo in subjects with previously untreated metastatic pancreatic 
ductal adenocarcinoma as measured by improvement in overall 
survival (OS).
Secondary Objectives:

Lead-in phase: To evaluate the efficacy of MMB combined with 
nab-P+G in subjects with previously untreated metastatic 
pancreatic ductal adenocarcinoma.

Randomized treatment phase: 
— To evaluate the efficacy of nab-P+G combined with either 
MMB or placebo as measured by improvement in progression 
free survival (PFS)
— To evaluate the efficacy of nab-P+G combined with either 
MMB or placebo as measured by improvement in objective 
response rate (ORR)
— To evaluate the safety and tolerability of nab-P+G combined 
with either MMB or placebo

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Study Design:
Lead-in: An open-label, non-randomized phase with dose escalation 
as shown in the following table.
Dose 
Level
MMB
G
nab-P
-2
100 mg 
once 
daily
800 
mg/m2
100 
mg/m2
  -1
100 mg 
once 
daily
1000 
mg/m2
100 
mg/m2
Dose 
Level
MMB
G
nab-P
1*
100 mg 
once 
daily
1000 
mg/m2
125 
mg/m2
2a
150 mg 
once 
daily
1000 
mg/m2
100 
mg/m2
2
150 mg 
once 
daily
1000 
mg/m2
125 
mg/m2
3a
200 mg 
once 
daily
1000 
mg/m2
100 
mg/m2
3
200 mg 
once 
daily
1000 
mg/m2
125 
mg/m2
4a
150 mg 
twice 
daily
1000 
mg/m2
100 
mg/m2
4
150 mg 
twice 
daily
1000 
mg/m2
125 
mg/m2
5a
200 mg 
twice 
daily
1000 
mg/m2
100 
mg/m2
5
200 mg 
twice 
daily
1000 
mg/m2
125 
mg/m2
*Starting dose
G: gemcitabine; MMB: momelotinib; nab-P: nab-paclitaxel
Three subjects will initially enroll into Dose Level 1. If no dose 
limiting toxicity (DLT) occurs in all 3 subjects during the first 28 days 
(Cycle 1) of treatment, 3 additional subjects will enroll into Dose 
Level 2.  If 1 DLT occurs in any Dose Level, that Dose Level will be 
expanded to enroll 3 additional subjects. If a second DLT occurs
within the same Dose Level after cohort expansion, the maximum 
tolerated dose (MTD) of nab-P+G combined with MMB has been 
exceeded. Dose escalation will continue from Dose Level 2 to 3 to 4 to 
5 if no DLT occurs in 3 subjects or < 2 DLTs occur in up to 6 subjects 
within each Dose Level.
If ≥ 2 DLTs occur in Dose Level 1, Dose Level -1 will open to enroll 
3 additional subjects.  If no DLT occurs in 3 subjects or < 2 DLTs 
occur in up to 6 subjects of Dose Level -1, then Dose Level -1 will be 
the MTD of nab-P+G combined with MMB. If ≥ 2 DLTs occur in 
Dose Level -1, Dose Level -2 will open to enroll 3 additional subjects. 
If no DLT occurs in 3 subjects or < 2 DLTs occur in up to 6 subjects 
of Dose Level -2, then Dose Level -2 will be the MTD of nab-P+G 
combined with MMB.  If ≥ 2 DLTs occur at Dose Level -2, the study 
will discontinue permanently. 

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If ≥ 2 DLTs occur in Dose Level 2, 3, 4, or 5 then Dose Level 2a, 3a, 
4a, or 5a will open, respectively.  If no DLT occurs in 3 subjects or 
< 2 DLTs occur in up to 6 subjects of Dose Level 2a, then Dose 
Level 3a will open to enroll 3 additional subjects. Dose escalation will 
continue from Dose Level 3a to 4a to 5a if no DLT occurs in 3 
subjects or < 2 DLTs occur in up to 6 subjects of each Dose Level. If 
≥2 DLTs occur in either Dose Level 2a, 3a, 4a, or 5a, then Dose 
Level 1, 2, 3, or 4 will be the MTD of nab-P+G combined with MMB, 
respectively.   
Please refer to Appendix 5 for flow diagram of dose escalation.
Dose limiting toxicities are based on the Common Terminology 
Criteria for Adverse Events (CTCAE) version 4.03. Dose limiting 
toxicities refer to toxicities experienced during the first 28 days 
(Cycle 1) of treatment that have been judged to be clinically 
significant and related to study treatment. A DLT is defined as:

Grade 4 neutropenia lasting > 7 days. Subjects who develop 
Grade 4 neutropenia during the first 28 days of treatment must 
have a repeat assessment of their neutrophil count 7 days after the 
onset of Grade 4 neutropenia to assess for this DLT.

Grade 4 neutropenia with fever (temperature 100.5º F)

Grade 4 thrombocytopenia lasting >7 days. Subjects who develop 
Grade 4 thrombocytopenia during the first 28 days of treatment 
must have a repeat assessment of their platelet count 7 days after 
the onset of Grade 4 thrombocytopenia to assess for this DLT.

Grade 3 or higher non-hematologic toxicity, excluding:
— Grade 3 nausea or emesis controlled by adequate medical 
therapy
— Grade 3 diarrhea controlled by adequate medical therapy
— Alopecia

After the MTD is established by lead-in phase, the study will 
proceed to the randomized treatment phase. 
Tumor biopsy will be performed at the time of the first restaging 
(at approximately week 8) in an optional substudy to investigate 
pharmacodynamic and mechanism of action biomarkers.

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Randomized Treatment: The randomized, double-blind, placebo-
controlled phase of the trial.  A total of 300 eligible subjects will be 
randomized in a 1:1 manner (150 subjects per treatment group) to 
receive either MMB or placebo in combination with nab-P+G in 28-
day cycles. Treatment assignment of this phase will be stratified by 
ECOG (0 vs. 1) and baseline c-reactive protein (CRP) plasma level 
(high vs. low). 
CT or MRI scans will be performed every 8 weeks to evaluate 
response to treatment by Response Evaluation Criteria In Solid Tumor 
(RECIST) v1.1 criteria. 
Tumor biopsy will be performed at the time of the first restaging 
(at approximately week 8) OR at the time of progression in an optional 
first OR second substudy to investigate pharmacodynamics, 
mechanism of action and resistance biomarkers.
Number of Subjects 
Planned:
Lead-in phase: 9 to 36 subjects
Randomized treatment phase: approximately 300 subjects
Target Population:
Previously untreated metastatic pancreatic ductal adenocarcinoma
Duration of 
Treatment:
Each treatment cycle will be 28 days. Treatment will continue in the 
absence of disease progression, unacceptable toxicity, consent 
withdrawal, or subject’s refusal of treatment.
Diagnosis and 
Eligibility Criteria:
Inclusion Criteria: 
1) Age ≥ 18 years old
2) Initial diagnosis of metastatic pancreatic adenocarcinoma must 
have occurred ≤ 6 weeks prior to randomization
3) The presence of metastatic pancreatic adenocarcinoma plus 1 of 
the following:

Histological diagnosis of pancreatic adenocarcinoma confirmed 
pathologically, OR

Pathologist confirmed histological/cytological diagnosis of 
adenocarcinoma consistent with pancreas origin in conjunction 
with either: 
— The presence of a mass in the pancreas, OR
— A history of resected pancreatic adenocarcinoma 
4) Measurable disease per RECIST v1.1

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5) Adequate organ function defined as follows:

Hepatic: Total  bilirubin ≤ 1.25 x upper limit of normal (ULN); 
AST (SGOT) and ALT (SGPT) ≤ 3 x upper limit of normal (ULN)

Hematological: Absolute neutrophil count (ANC) > 1500
cells/mm3, platelet > 100,000 cells/mm3, hemoglobin > 9 g/dL

Renal: Serum creatinine < 1.5 x ULN OR calculated creatinine 
clearance (CrCl) ≥ 60 ml/min as calculated by the Cockroft-Gault 
method
6) Eastern Cooperative Oncology Group (ECOG) Performance Status 
of 0 or 1
7) Negative serum pregnancy test for female subjects (unless 
surgically sterile or greater than two years postmenopausal)
8) Male and female subjects of childbearing potential who engage in 
heterosexual intercourse must agree to use protocol specified 
method(s) of contraception as described in Appendix 3
9) Females who are nursing must agree to discontinue nursing before 
the first dose of investigational product (IP)
10) Able to comprehend and willing to sign the written informed 
consent form
(Diagnosis and 
Eligibility Criteria 
(Continued):
Exclusion Criteria: 
1) Neoadjuvant or adjuvant chemotherapy or chemoradiotherapy for 
pancreatic adenocarcinoma
2) Currently or previously treated with biologic, small molecule, 
immunotherapy, chemotherapy, or other agents for metastatic 
pancreatic carcinoma
3) Uncontrolled intercurrent illness including, but not limited to, 
active uncontrolled infection, active or chronic bleeding event 
within 4 weeks prior to first dose of IP, uncontrolled cardiac 
arrhythmia, or psychiatric illness/social situation that would limit 
compliance with study requirements as judged by treating 
physician

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4) History of a concurrent or second malignancy except for 
adequately treated local basal cell or squamous cell carcinoma of 
the skin, cervical carcinoma in situ, superficial bladder cancer, 
asymptomatic prostate cancer without known metastatic disease 
and with no requirement for therapy or requiring only hormonal 
therapy and with normal prostate-specific antigen for ≥ 1 year 
prior to randomization, adequately treated Stage 1 or 2 cancer 
currently in complete remission, or any other cancer that has been 
in complete remission for ≥ 5 years
5) Major surgery, defined as any surgical procedure that involves 
general anesthesia and a significant incision (ie, larger than what is
required for placement of central venous access, percutaneous 
feeding tube, or biopsy), within 28 days of first dose of IP
6) Minor surgical procedure(s) within 7 days of randomization or not 
yet recovered from prior minor surgery (placement of central 
venous access device, fine needle aspiration, or endoscopic biliary 
stent ≥ 1 day before randomization is acceptable)
7) Known positive status for human immunodeficiency virus (HIV)
8) Chronic active or acute viral hepatitis A, B, or C infection (testing 
required for hepatitis B and C), or hepatitis B or C carrier
9) Peripheral neuropathy ≥ Grade 2
10) Known or suspected brain or central nervous system metastases
11) Diagnosis of pancreatic islet neoplasm, acinar cell carcinoma, 
non-adenocarcinoma (ie, lymphoma, sarcoma), adenocarcinoma 
originating from the biliary tree or cystadenocarcinoma
12) History of interstitial pneumonitis
13) External biliary drain
14) Paracentesis or thoracentesis for malignant effusion within 14 days 
of randomization
15) Documented myocardial infarction or unstable/uncontrolled 
cardiac disease (ie, unstable angina, congestive heart failure 
[New York Heart Association > Class III]) within 6 months of 
randomization
16) Use of strong CYP3A4 inhibitors or strong CYP3A4 inducers 
within 1 week prior to the first dose of IP
17) Known hypersensitivity to MMB, gemcitabine and/or 
nab-paclitaxel, their metabolites, or formulation excipients

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18) Uncontrolled hypertension (seated systolic blood pressure 
>180 mmHg or diastolic blood pressure >110 mmHg) at Screening
19) QTc interval > 450 msec, unless attributed to bundle branch block
20) Pregnant
Study Procedures/
Frequency:
Screening: 
Screening will commence with obtaining the subject’s signed 
informed consent and will occur up to 21 days prior to first dose of IP 
(MMB) for the lead-in phase or randomization for the randomized 
treatment phase. Screening procedures will include the following: 
medical history review, physical exam, vital signs, 12-lead ECG, 
ECOG performance status, prior/ concomitant medication review, 
blood collection for pregnancy test (females), laboratory assessment, 
adverse event (AE) assessment, and CT or MRI (scans obtained as 
part of standard medical practice up to 21 days during the screening 
period are acceptable). 
Treatment Phase:
Lead-in: Each treatment cycle is 28 days. Subjects meeting eligibility 
will undergo 3 weekly visits each cycle. Beginning with Day 1 of 
Cycle 1, subjects will self-administer MMB orally once daily or twice 
daily in the morning and evening as per the dosing cohort they are 
assigned to. All subjects will also receive nab-P+G administered 
intravenously on Days 1, 8, and 15 of each cycle. Staging scan will be 
performed at baseline and approximately every 8 weeks thereafter.
After discontinuation of treatment, subjects will be followed for safety 
for 30 days and for survival approximately every 6 months for up to 
5 years.
Randomized treatment: Each treatment cycle is 28 days. Subjects 
meeting eligibility will undergo 3 weekly visits each cycle. Beginning 
with Day 1 of Cycle 1, subjects will self-administer MMB or placebo. 
All subjects will also receive nab-P+G administered intravenously on 
Days 1, 8, and 15 of each cycle. Staging scan will be performed at 
baseline and approximately every 8 weeks thereafter.
After discontinuation of treatment, subjects will be followed for safety 
for 30 days and for survival approximately every 6 months for up to 
5 years.
Test Product, Dose, 
and Mode of 
Administration:
MMB tablet will be self-administered orally once daily or twice daily 
in the morning and evening (dose frequency as instructed by clinical 
investigator), beginning on Day 1 of the study, and thereafter at 
approximately the same time each day until end of treatment.  

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Gilead Sciences, Inc. 
Reference Therapy, 
Dose, and Mode of 
Administration: 
Criteria for 
Evaluation: 
Safety: 
Efficacy: 
Phrum acokinetic: 
Phrum acodynamic 
and Explorat01y 
Biomru·kers: 
CONFIDENTIAL 
Final 
Original 
Nab-paclitaxel intravenously over 30-40 minutes or as per institutional 
standard of care followed immediately by gemcitabine intravenously 
over 30 minutes or as per institutional standard of care on Days 1, 8, 
and 15. Cycle repeats eve1y 28 days. 
The overall safety profile of each treatment group will be 
chru·acterized by the type, frequency, severity, timing of onset, 
dmation, and relationship to study dmg of any adverse events (AEs) or 
abnonnalities oflaborat01y tests; serious adverse events (SAEs); or 
AEs leading to discontinuation of study dmg. 
Primaty Endpoints: 
Lead-in: Incidence of dose limiting toxicities (DLTs) as defined in 
Section 3.1 
Randomized treatment: Overall survival (OS), defined as the interval 
from randomization to death fi:om any cause 
Secondaty Endpoints: 
Overall response rate (ORR) (complete response [CR] + pruiial 
response [PR ]), assessed as per RECIST v 1.1 
Progression-free survival (PFS), defined as the interval from 
randomization to the eru·lier of the first documentation of definitive 
disease progression or death from any cause 
Overall survival will also be the secondruy endpoint for the lead-in 
phase 
Explorat01y endpoints are described in the body of the protocol 
Phrum acokinetic (PK) blood saiUples will be collected at the 
timepoints specified in the protocol. 
PPD 
Page 13 
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Statistical Methods:
Analysis Methods
The Intent-to-Treat (ITT) Analysis Set will be used in the analyses of 
the primary efficacy endpoint, OS. The ITT Analysis Set consists of
all randomized subjects, with study treatment assignment designated 
according to initial randomization. A Safety Analysis Set consists of 
subjects in the ITT Analysis Set who received 1 dose of study drug, 
with study treatment designated according to the actual treatment 
received.  Other analysis sets [per-protocol (PP) and 
PK/pharmacodynamic analysis sets] will be used for additional 
analyses as well.
Unless otherwise specified, data from the lead-in and randomized 
treatment parts will be summarized and analyzed separately.
Subject characteristics and study results will be described and 
summarized by treatment arm and assessment for the relevant analysis 
sets. Descriptive summaries will be prepared to show sample size, 
mean, standard deviation (StD), 95% confidence intervals (CIs) on the 
mean, median, minimum and maximum for continuous variables and 
counts, percentages and 95% CIs on the percentage for categorical 
variables.
For the primary efficacy analysis, the difference in OS between the 
treatment arms will be assessed in the ITT Analysis Set using 
Kaplan-Meier (KM) methods and the stratified log-rank test. Medians, 
ranges, the proportion of subjects who are surviving at 24 and 
48 weeks from randomization (based on KM estimates), hazard ratios, 
and the corresponding 95% CIs (as calculated using a Cox 
proportional hazards regression model) will be presented.
Efficacy endpoints will be analyzed based on the ITT and PP Analysis 
Sets, with ITT Analysis Set as primary. Time-to-event efficacy 
endpoints will be analyzed in a similar manner as OS. Categorical 
endpoints will be compared using the Cochran-Mantel-Haenszel 
(CMH) test adjusted for stratification factors. Continuous endpoints 
will be assessed using analysis of covariance (ANCOVA) with 
treatment and stratification factors as factor and baseline value as 
covariate.
Based on the Safety Analysis Set, information regarding IP 
administration, IP compliance and safety variables will be described 
and summarized.
Using data from the PK and pharmacodynamic Analysis Sets, MMB 
plasma concentrations and pharmacodynamic markers will also be 
described and summarized.

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Sample Size Calculation
Based on the historical data (MPACT trial in patients with metastatic 
pancreatic cancer), the median OS was 8.5 months in the nab-P+G
group. Ruxolitinib Phase II RECAP trial (ruxolitinib or placebo in 
combination with capecitabine in patients with refractory metastatic 
pancreatic cancer) reported, in a pre-specified subgroup identified 
prospectively as most likely to benefit from JAK inhibitor treatment, a 
hazard ratio (HR) for OS of 0.47.
For the randomized treatment phase of the study, a total of 162 OS 
events need to be observed to detect a HR of 0.6 with 90% power at a 
2-sided 0.05 significance level. Assuming an accrual rate of 20
subjects per month, median OS of 8.5 months in the control arm, and 
no lost-to- follow-up, a sample size of 150 subjects in each arm need 
to be enrolled to observe the 162 OS events. The expected study 
duration of observing 162 OS events in the randomized treatment 
phase is ~21 months. One interim analysis will be conducted when 
81 OS events have been observed. An O’Brien-Fleming boundary will 
be applied to assess the efficacy at the interim analysis. The efficacy 
boundaries (p-value) for the interim and final analyses will be 0.003
and 0.049, respectively.
This study will be conducted in accordance with the guidelines of Good Clinical Practice (GCP) 
including archiving of essential documents.

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GLOSSARY OF ABBREVIATIONS AND DEFINITION OF TERMS
C 
degrees Celsius
F
degrees Fahrenheit
ADME
absorption, distribution, metabolism, elimination
AE
adverse event
AKT
Protein Kinase B
ALT
alanine transaminase
AM
morning
ANC
absolute neutrophil count
ANCOVA
analysis of covariance
aPTT
activated partial thromboplastin
AST
aspartate transaminase
AUC
area under the plasma/serum/peripheral mononuclear cell concentration versus time curve 
AUC0-last
area under the concentration verses time curve from time 0 to the last quantifiable 
concentrations
AUCinf
area under the concentration versus time curve extrapolated to infinite time, calculated as 
AUC0-last + (Clast/λz)
AUCτ
area under the concentration versus time curve over the dosing interval 
BCRP
breast cancer resistance protein
BSEP
bile salt export pump
BUN
blood urea nitrogen
C1D1
Cycle 1 Day 1
CBC
complete blood count
CEA
carcinoembryonic antigen
CFR
Code of Federal Regulations 
CI
confidence interval
Clast
last observed quantifiable plasma concentration of drug
CL/F
apparent oral clearance after administration of the drug:
CL/F= Dose/AUCinf
where “dose” is the dose of the drug
Cmax
maximum observed serum/plasma concentration of drug
CMH
Cochran-Mantel-Haenszel
Conmed
concomitant medication
CR
complete response
CrCL
creatinine clearance
CRF
case report form(s)
CRO
contract (or clinical) research organization 
CRP
c-reactive protein
CSR
clinical study report

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GLOSSARY OF ABBREVIATIONS AND DEFINITION OF TERMS (CONTINUED)
CT
computed tomography/ computed axial tomography scan
CTCAE
Common Terminology Criteria for Adverse Events
CYP450
cytochrome P450
DDI
drug-drug interaction
DLT
dose limiting toxicity 
DMC
data monitoring committee
DNA
deoxyribonucleic acid 
DOR
duration of response
DSPH
Drug Safety and Public Health
ECG
electrocardiogram
ECOG
Eastern Cooperative Oncology Group
eCRF
electronic case report form(s)
EOT
end of treatment
eSAE
electronic serious adverse event
ET
essential thrombocythemia
EudraCT
European clinical trials database
EU
European Union
EQ-5D
EuroQoL-5D 
FACT-Hep
Functional Assessment of Cancer Therapy – Hepatobiliary
FDA
(United States) Food and Drug Administration
G
gemcitabine
GCP
Good Clinical Practice (Guidelines)
GGT
gamma-glutamyl transpeptidase
GLP
good laboratory practice
GSI
Gilead Sciences, Inc.
H
hour
hCG
human chorionic gonadotropin
HIV
human immunodeficiency virus
HR
hazard ratio
IB
investigator’s brochure
IC50
inhibitory concentration 50
ICF
informed consent form
ICH
International Conference on Harmonisation
IEC
Independent Ethics Committee
IL
interleukin 
IND
Investigational New Drug
INR
international normalized ratio
IP
investigational product

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GLOSSARY OF ABBREVIATIONS AND DEFINITION OF TERMS (CONTINUED)
IRB
Institutional Review Board
ITT
Intent-to-Treat
IUD
Intrauterine device(s)
IXRS
interactive voice/web response system
JAK
Janus Kinase
kg
kilogram
KM
Kaplan-Meier
KRAS
Kirsten rat sarcoma viral oncogene homolog
LDH
lactate dehydrogenase
MAPK
mitogen-activated protein kinase
MedDRA
Medical Dictionary for Regulatory Activities
MF
myelofibrosis
µM
micromole
msec
millisecond
MMB
momelotinib
MRD
maximum recommended dose
MRI
magnetic resonance imaging
MTD
maximum tolerated dose
N
number enrolled
nab-P
nab-paclitaxel
NOAEL
no observed adverse effect level
OAT
organic anion transporter
OCT
organic cation transporter
OS
overall survival
ORR
objective response rate
PD
progressive disease
PE
physical exam
PFS
progression-free survival
P-gp
permeability glycoprotein
PI3K-AKT
phosphatidylinositol-3-kinase and protein kinase B
PK
pharmacokinetic
PP
Per-Protocol
PR
partial response
PRO
patient-reported outcome(s)
PT
prothrombin time
PTT
partial thromboplastin time
PTM
placebo to match
PV
polycythemia vera

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GLOSSARY OF ABBREVIATIONS AND DEFINITION OF TERMS (CONTINUED)
QTc
corrected QT interval
RAF
rapidly accelerated fibrosarcoma
RBC
red blood cell
RECIST
Response Evaluation Criteria In Solid Tumor
RNA
ribonucleic acid
RP2D
recommended Phase 2 dose 
SADR
serious adverse drug reaction(s)
SAE
serious adverse event(s)
SAP
statistical analysis plan
SD
stable disease
SGOT
serum glutamic oxaloacetic transaminase
SGPT
serum glutamic pyruvate transaminase
SOP
standard operating procedure
STAT
Signal Transducer and Activator of Transcription
StD
standard deviation
sTNFR
soluble tumor necrosis factor receptor 
SUSAR
suspected unexpected serious adverse reaction(s)
T1/2
an estimate of the terminal elimination half-life of the drug in serum/plasma, calculated by 
dividing the natural log of 2 by the terminal elimination rate constant  (z)
Tlast
the time (observed time point) of Clast
Tmax
the time (observed time point) of Cmax
TBK1
TANK-binding kinase 1
TTR
time to response
TYK2
tyrosine kinase 2
ULN
upper limit of normal 
WBC
white blood cell
z
terminal elimination rate constant, estimated by linear regression of the terminal 
elimination phase of the serum, plasma concentration of drug versus time curve
5-FU
5-fluorouracil

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1.
INTRODUCTION
1.1.
Background
Pancreatic carcinoma is the fourth leading cause of cancer-related death and in 2013, an 
estimated 45,220 new cases of pancreatic carcinoma will be diagnosed in the United States (US), 
and an estimated 38,460 people will die from the disease {24651}. Overall prognosis of 
pancreatic carcinoma is poor, with surgical tumor resection being the only effective cure 
although only 10-15% of patients are candidates for surgical resection {27725}. 
For those with metastatic disease, systemic therapy is the treatment of choice. Gemcitabine has 
been a preferred first-line monotherapy option for those with metastatic disease based on the 
finding that it is more effective than bolus 5-fluorouracil (5-FU) in palliating symptoms of
advanced pancreatic cancer, with clinical benefit rates of 23.8% for gemcitabine versus 4.8% for 
5-FU.  Median survival was 4.4 months for 5-FU, and 5.7 months for gemcitabine {17153}.
In 2011, results from a Phase 1/2, single arm study of albumin-bound paclitaxel + gemcitabine 
(nab-P+G) in patients with advanced pancreatic cancer were published, revealing a response rate
of 48%, overall survival of 12.2 months, and 1-year survival rate of 48% for the two-drug 
regimen {27728}.  Data from a subsequent randomized Phase 3 study of nab-P+G compared to 
gemcitabine alone in patients with metastatic adenocarcinoma of the pancreas (MPACT trial) 
confirmed the survival improvement for the combination regimen, ie, 8.5 months for nab-P+G 
versus 6.7 months for gemcitabine alone (p<0.001).  Progression-free survival was 5.5 months 
for nab-P+G, versus 3.7 months for gemcitabine alone (p<0.001). Survival rates were 35% and 
22% for nab-P+G and gemcitabine alone at 1 year, respectively {27729}. Based on these results, 
the combination of nab-P+G was approved by the Food and Drug Administration (FDA) as first 
line therapy for metastatic pancreatic carcinoma.  Another combination regimen that has also 
demonstrated improvement in PFS and OS in patients with metastatic pancreatic carcinoma is 
the 4-drug combination of oxaliplatin, irinotecan, leucovorin, and fluorouracil administered as
per the FOLFIRINOX regimen {21890}.
1.2.
Momelotinib (MMB)
1.2.1.
General Information
MMB dihydrochloride (N-(cyanomethyl)-4-(2-(4-morpholinophenylamino)pyrimidin-4-
yl)benzamide, CYT387, GS-0387) is a novel, weakly basic, disubstituted pyrimidine compound 
with a molecular weight of 487.38 Da. The free base is poorly soluble in water. MMB is 
presented for clinical administration as a dihydrochloride monohydrate salt. The dihydrochloride 
monohydrate salt shows kinetic solubility in water at concentrations up to 60 mg/mL. MMB
dihydrochloride is manufactured from a pyrimidine scaffold in a five-step process. 

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In cellular assays and in vitro, MMB was shown to be a potent and selective ATP-competitive
small-molecule inhibitor of Janus kinase 1 (JAK1) and JAK2, and is active at low nanomolar 
concentrations. MMB demonstrates marked disease-modifying properties in ex vivo assays of 
human erythroid cells from polycythemia vera patients and in a transgenic mouse model of 
myeloproliferative neoplasm. Kinase profiling of MMB indicates the compound is broadly 
selective for JAK1 and JAK2 over other kinase enzymes, including the closely related JAK3 and
tyrosine kinase 2 (TYK2). MMB displays potent in vitro inhibitory activity against cells 
dependent on JAK2.
For further information on MMB, refer to the current edition of the investigator’s brochure (IB) 
for MMB.
1.2.2.
Nonclinical Pharmacology and Toxicology
1.2.2.1.
Absorption, Distribution, Metabolism, and Elimination (ADME)
Equivalent mean maximal plasma concentrations of MMB (~700 ng/mL) and comparable 
elimination half-lives (~1h) were observed in both fed and fasted animals, consistent with 
previous data. There was however a notable prolongation in absorption in fed dogs with a 
delayed Tmax (3h fed vs. 1h fasted). Furthermore, the AUC following dosing to feed dogs was 
approximately double that seen in fasted animal studies suggesting that MMB systemic 
availability is markedly improved when the compound is administered postprandially.
Consistent with the moderate to high bioavailability seen in nonclinical species, MMB shows 
high permeability in vitro across human Caco-2 cell monolayers with low efflux potential. These 
results indicate that MMB is likely to have high permeability across the intestinal mucosa in 
humans and high oral absorption in vivo. 
Data from plasma protein binding studies using rat and human plasma indicate that MMB binds 
extensively to rat plasma proteins (~ 97%) and moderately to human plasma proteins 
(87% to 92%). The mean human blood-to-plasma ratio was determined to be approximately 1.1, 
suggesting similar distribution between the cellular and plasma fractions of blood. The rat 
blood-to-plasma ratio ranged from 0.6 to 0.8 indicating a lesser partitioning into blood cells. 
The systemic clearance of MMB was low in rats and significantly higher in dogs. The 
steady-state volume of distribution in both species substantially exceeded total body water.
Following oral administration as the dihydrochloride salt, MMB showed high bioavailability in 
the rat (50%) and moderate bioavailability in the dog (20%). The PK parameters in both the rat 
and dog indicated that MMB was well absorbed. In the rat, less than 10% of an administered 
dose of MMB was recovered in the urine as parent compound suggesting that urinary excretion 
is a minor clearance route for the parent compound.
The distribution of MMB into brain tissue was assessed in Swiss outbred mice following 
intravenous administration (5 mg/kg). The brain-to-plasma ratio for MMB was determined to be 
0.075 and 0.215 at 5 and 60 minutes following MMB administration, respectively, suggesting 
low permeability of MMB across the blood brain barrier.

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Metabolite profiling has identified major putative metabolites from in vitro and in vivo studies.
Metabolite M19 (GS-642112) was present in greater amounts in both rat (both dose levels) and 
dog plasma pools, than in the human plasma pool. Metabolites M15, M17, and M20 were present 
in greater amounts in the rat plasma pool (both dose levels), than in the human or dog plasma 
pools. Metabolite M21 (GS-644603) was present in human plasma at higher levels than that 
observed in rat plasma (20 mg/kg or 80 mg/kg doses, respectively). Metabolite M21 was not 
observed in the dog plasma. M8 was not observed in either the rat or dog plasma pools. 
The ability of the major drug-metabolizing CYP450 enzymes (CYP1A2, 2A6, CYP2B6, 
CYP2C9, CYP2C19, CYP2D6, CYP2E1, CYP3A4 and CYP3A5) to metabolize MMB was 
assessed with recombinant human CYP450 enzymes (Supersomes). These in vitro studies 
demonstrated that MMB is partially metabolized by CYP3A4 and aldehyde oxidase.
The potential of MMB to impair the metabolism of other agents by inhibition of major drug 
metabolizing enzymes has also been investigated. The half-maximal inhibitory concentration 
(IC50) of MMB on the five CYP isoforms investigated (CYP1A2, CYP2C9, CYP2C19, 
CYP2D6, and CYP3A4) was greater than 25 μM. MMB is therefore unlikely to mediate 
significant metabolic drug-drug interactions through inhibition of these isoforms in vivo. MMB
was determined to have the potential to be an inhibitor of UGT1A1, a major human uridine 
diphosphate glucuronosyltransferase enzyme responsible for the glucuronidation of bilirubin, 
with an IC50 of 0.3 μM but it is not clinically relevant as no clinically significant elevation of 
indirect (unconjugated) bilirubin has been reported in the Phase 1/2 CCL09101 study.
The potential of MMB to inhibit the major drug transporters was studied in cells in which the 
individual transporters were over expressed and determining were possible the MMB IC50 for the 
transport of probe substrates. MMB did not significantly inhibit P-gp, OAT1, OAT3, OCT1, 
OCT2, OATP1B1, OATP1B3 or BSEP mediated transport of probe substrates at 15 μM. MMB
was determined to be an inhibitor of BCRP with an IC50 of 2.9 μM.
1.2.2.2.
Nonclinical Toxicology
Nonclinical safety pharmacology and toxicology studies have characterized the safety of MMB
and included both repeat dose toxicology studies and in vitro genotoxicity studies. All pivotal 
toxicology studies, including the genotoxicity studies, were conducted in full compliance with 
GLP regulations (21 CFR 58). The scope of the nonclinical safety evaluation is consistent with 
guidance issued by the International Conference on Harmonisation (ICH).
The potential for MMB to induce hemodynamic or ECG effects was evaluated in male beagle 
dogs following a single oral dose of 5, 30 or 100 mg/kg. A marked decrease in mean arterial 
pressure and increase in heart rate was observed after a single dose of 100 mg/kg.
Toxicological findings were principally related to the pharmacological action of the compound, 
as indicated by hematological and organ weight changes related to lymphatic and bone marrow 
tissues. A dose-dependent decrease in body weight gain, correlated with a dose-dependent 
decrease in food consumption, was observed in all studies and considered significant at 
high-dose levels in all studies except the 13-week dog study. Following very high exposure 
levels in the rat 28-day study, some off-target reversible toxicity was observed that included 
changes in the kidney, gastrointestinal tract, heart, and liver, of which none were observed in the 

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rat 13-week study or the dog studies. Female reproductive changes were observed only at high 
doses in the rat 28-day study and were reversible. Dose-dependent testicular degeneration was 
observed in rats following 28 days or 13 weeks of repeated dosing. Recovery of testicular 
findings was dependent upon the cycle length of spermatogenesis with reversibility observed 
after a 10-week recovery period (13-week study) but not after a 28-day recovery period 
(28-day study). These changes were not observed above background levels in sexually mature 
dogs consistent with the role of JAK2 in maturation of the reproductive organs {24788}.
There were several effects observed that could not be readily attributed to JAK1 and JAK2
inhibition. This potential off-target toxicity was noted in the kidney, heart, and gastrointestinal
tract of the rat, and gall bladder of the dog. All effects were reversible upon cessation of dosing.
In the 90-day oral rat toxicity study, based upon the significant loss of body weight at 
80 mg/kg/day, the no observed adverse effect level (NOAEL) was determined as 20 mg/kg/day, 
with associated Day 91 AUC0-24 values of 94,200 ng·h/mL in males and 102,000 ng h/mL in 
females. The Cmax values in males and females on day 91 were 6720 and 7290 ng/mL, 
respectively.
In the 3-month dog study, the highest NOAEL was 60 mg/kg/day once daily. Associated 
AUC0-12 values at the NOAEL on Day 91 were 4160 and 3220 ng·h/mL, respectively. The Cmax
values in males and females on day 91 were 1250 and 1150 ng/mL, respectively 
The plasma AUCτ in patients from Study CCL09101 at 300 mg capsule was 4.3 μg h/mL. 
Therefore, the margin of exposure for the NOAEL in the 90-day toxicity studies to the steady 
state AUC NOAEL is 22 in the rat and 0.8 in the dogs.
An in vitro bacterial reverse mutation assay (Ames test), an in vitro mammalian cell gene 
mutation assay (chromosomal aberration test), and an in vivo rat bone marrow micronucleus 
assay were conducted with MMB. No evidence of mutagenicity or clastogenicity was observed 
indicating a low potential for MMB to cause genotoxicity. 
Preliminary data from a dose range finding embryo-fetal developmental toxicity study in rats are 
available. MMB was orally administered to pregnant rats (7 to 8/group plus additional animals 
for TK evaluations) at 0 (vehicle), 4.3, 17, and 68 mg free base equivalents/kg/day (5, 20, 
80 mg/kg/day dihydrochloride salt) from gestation days 6 through 17. Based on the preliminary 
data, no maternal adverse effects and no embryo fetal adverse events were observed at 
4.3 mg/kg/day. Maternal toxicity was observed at 17 and 68 mg/kg/day. At these maternally 
toxic doses, MMB administration resulted in embryo fetal effects (increase in post implantation 
loss resulting in a reduced number of viable fetuses). No viable fetuses were obtained at 
68 mg/kg/day. At 17 mg/kg/day, there was an increase in the percentage of litters with absent 
innominate artery. The toxicokinetic data is not yet available from this study. Based on the data 
from non-pregnant female rats, the mean systemic exposure (AUC0-24) at the NOAEL is 4-fold 
higher than the systemic exposure observed in patients administered 300 mg MMB, the 
maximum recommended dose (MRD). The exposure of MMB in non-pregnant rats at 
17 mg/kg/day, the current minimum effect level, is approximately 23 fold higher than the MRD.
A more detailed summary of findings from the studies in rats and dogs is available in the IB for 
MMB. Investigators should refer to this document prior to initiating therapy with MMB.

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1.2.3.
Clinical Trials of Momelotinib
As of November 2013, 4 clinical studies of MMB have been completed and 3 clinical studies are 
ongoing. 
Completed Clinical Trials

Study YM387-I-02, A Randomized, Open-Label, 4-Way Crossover Study to Evaluate the 
Relative Bioavailability of Single Oral Doses of CYT387 Capsule Formulation versus Tablet 
Formulation and a Food Effect in Healthy Adult Volunteers

Study CCL09101, A Phase I/II, Open-Label, Dose-Escalation Study Evaluating the Safety, 
Tolerability, Pharmacokinetics and Pharmacodynamics of Orally-Administered CYT387 in 
Primary Myelofibrosis or Post-Polycythemia Vera Myelofibrosis or Post-Essential 
Thrombocythemia Myelofibrosis

Study GS-US-352-0102, A Phase 1 Study of a Novel Formulation of GS-0387 to Determine 
the Relative Bioavailability, Food Effect, and Interaction with Omeprazole in Healthy 
Volunteers

Study GS-US-352-1149, A Phase 1 Study to Evaluate the Pharmacokinetics, Metabolism,
and Excretion of Momelotinib
Ongoing Clinical Trials

Study CCL09101E, A Phase II, Open-Label Extension Study Evaluating the Long Term 
Safety, Tolerability & Efficacy of Orally-Administered CYT387 in Primary Myelofibrosis or 
Post-Polycythemia Vera or Post-Essential Thrombocythemia Myelofibrosis

StudyYM387-II-02, A Phase I/II, Open-Label Study Evaluating Twice-Daily Administration 
of CYT387 in Primary Myelofibrosis or Post-Polycythemia Vera or Post-Essential 
Thrombocythemia Myelofibrosis 

Study GS-US-352-0101, A Phase 3, Randomized, Double-blind Active-controlled Study 
Evaluating Momelotinib vs. Ruxolitinib in Subjects with Primary Myelofibrosis (PMF) or 
Post-Polycythemia Vera or Post-Essential Thrombocythemia Myelofibrosis 
(Post-PV/ET MF)
1.3.
Anticipated Risk
A recent clinical trial of the JAK2 inhibitor fedratinib (SAR302503) in myelofibrosis was halted 
due to reported cases of Wernicke’s encephalopathy.  Wernicke’s encephalopathy has not been 
reported in clinical trials with MMB.  Peripheral neuropathy, however, has been reported as an 
adverse event. To further understand the possible mechanism and/or contributing factors of 
peripheral neuropathy, thiamine status will be monitored during the treatment phase of this 
study.

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1.4.
Rationale for This Study
Signaling pathways that play an important role in pancreatic carcinoma cell growth and 
differentiation include the JAK-STAT pathway.  In particular, STAT3 has been identified as a 
key oncogenic factor in a number of epithelial malignancies, with aberrant STAT3 activation 
shown to be a requirement for the survival of several types of human cancer cells, promoting the 
over-expression of genes that encode anti-apoptotic proteins, cell-cycle regulators, and 
angiogenic factors {27599}, {27604}.  In normal pancreas, STAT3 is not vital for normal 
development but in the majority of pancreatic adenocarcinomas, there is constitutive activation 
of STAT3 {27727}.  Mouse models that tested the impact of conditional inactivation of STAT3 
in pancreatic ductal adenocarcinomas have demonstrated the requirement of STAT3 in multiple 
steps of pancreatic carcinoma pathogenesis including development of the earliest premalignant 
pancreatic lesions, acinar-to-ductal metaplasia, and formation of pancreatic intraepithelial 
neoplasia {27601}.  Furthermore, exposure of pancreatic tumor cells to the JAK2 inhibitor 
AG490 was shown to significantly inhibit the expression of phosphorylated STAT3 with 
subsequent reduction in the invasion and adhesion potential of human pancreatic tumor cells 
along with decrease in the expression of cyclin D1, bcl-xL, and vascular endothelial growth 
factor mRNAs, followed by growth arrest {27605}, {27612}.
MMB, in addition to being a JAK inhibitor, also has inhibitory activity against TANK binding 
kinase 1 (TBK1).  Mutations in KRAS, present in approximately 90% of pancreatic carcinomas, 
drive tumor growth by engaging multiple downstream mitogenic and pro-survival pathways 
including the RAF-MAPK and PI3K-AKT pathways {27602}.  Utilizing systematic RNA 
interference to detect synthetic lethal partners of oncogenic KRAS, TBK1 was found to be 
selectively essential in cells that contain mutant KRAS.  Upon suppression of TBK1, apoptosis 
was induced in human cancer cells that depended on oncogenic KRAS expression along with
reduction in cell proliferation and colony formation, suggesting TBK1 pathway perturbation may 
represent a method of targeting oncogenic KRAS-driven cancers {27596}, {27726}.
In the clinical setting, benefits of JAK inhibition were reported in patients from the RECAP trial, 
a randomized, double blind, placebo-controlled study of capecitabine combined with either 
ruxolitinib (JAK1/2 inhibitor) or placebo in patients with recurrent or refractory metastatic 
pancreatic carcinoma.  In a pre-specified subgroup analysis conducted in patients identified 
prospectively as being most likely to benefit from JAK inhibitor treatment, the hazard ratio for 
survival was 0.47 (p=0.005).  Within this subgroup of patients, 6 months survival in the 
ruxolitinib arm was 42%, compared to 11% for placebo (Incyte Corporation press release 
21 Aug 2013, http://investor.incyte.com/phoenix.zhtml?c=69764&p=irol-
newsArticle&ID=1848898&highlight=).
In light of these findings, the safety and efficacy of MMB in combination with chemotherapy for 
patients with previously untreated metastatic pancreatic ductal adenocarcinoma will be 
investigated in this study. Based on dose/exposure-response of Study CCL09101 in 
myelofibrosis, the MMB starting dose of 100 mg once-daily has the potential to be efficacious.  
The highest escalated dose of 200 mg twice-daily is expected to provide longer duration of target 
inhibition.

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1.5.
Compliance
This study will be conducted in compliance with this protocol, Good Clinical Practice (GCP), 
and all applicable regulatory requirements.

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2. 
OBJECTIVES 
Primary Objectives: 
Final 
Original 
• 
Lead-in phase: To evaluate the safety, phannacokinetics, and define the MTD ofMMB 
combined with nab-P+G in subjects with previously untreated metastatic pancreatic ductal 
adenocarcinoma 
• 
Randomized u·eatment phase: To detennine the efficacy ofnab-P+G combined with either 
MMB or placebo as first line therapy in subjects with previously unu·eated metastatic 
pancreatic ductal adenocarcinoma as measmed by improvement in overall survival (OS). 
Secondary Objectives: 
• 
Lead-in phase: To evaluate the efficacy ofMMB combined with nab-P+G in subjects with 
previously unu·eated metastatic pancreatic ductal adenocarcinoma. 
• 
Randomized u·eatment phase: 
-
To evaluate the efficacy of nab-P+G combined with either MMB or placebo as measmed 
by improvement in PFS 
-
To evaluate the efficacy of nab-P+G combined with either MMB or placebo as measmed 
by improvement in ORR 
-
To evaluate the safety and tolerability of nab-P+G combined with either MMB or placebo 
Explorat01y Objectives: 
IT 
I 
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3. 
STUDY DESIGN 
3.1. 
Study Design 
Final 
Original 
There will be a screening period of up to 21 days to assess subject eligibility including 
confmnation of previously 1m treated metastatic pancreatic ductal adenocarcinoma. CT or MRI 
scans of the tumor will be required within 21 days of first dose ofiP (MMB) for the lead-in 
phase or randomization for the randomized treatment phase to assess subject disease status prior 
to treatment. This study will consist of 2 sequential phases: Lead-in and Randomized treatment. 
The end of this trial is defined as the date of the last study contact of the last study subject. 
Lead-in: The study will begin with an open-label, non-randomized, dose-finding phase to define 
the MTD ofMMB in combination with nab-P+G in pancreatic adenocarcinoma patients. Dose 
escalation is shown in Table 3-1. 
Table 3-1. 
Dose Escalation Scheme 
Dose 
Level 
MMB 
G 
nab-P 
-2 
100 mg 
800 mg/m2 
100 mg/m2 
once daily 
-1 
100mg 
1000 
100 mg/m2 
once daily 
mg/m2 
DOS(' 
Levl'l 
MMB 
G 
nab-P 
1* 
100 mg 
1000 
125 mg/m2 
once daily 
mg/m2 
2a 
150 mg 
1000 
100 
once daily 
mg/m2 
mg/m2 
2 
150mg 
1000 
125 mg/m2 
once daily 
mg/m2 
3a 
200 mg 
1000 
100 
once daily 
mg/m2 
mg/m2 
3 
200mg 
1000 
125 mg/m2 
once daily 
mg/m2 
4a 
150mg 
1000 
100 
tv-rice daily 
mg/m2 
mg/m2 
4 
150 mg 
1000 
125 mg/m2 
twice daily 
mg/m2 
5a 
200mg 
1000 
100 
twice daily 
mg/m2 
mg/m2 
5 
200mg 
1000 
125 mg/m2 
twice daily 
mg/m2 
*Starting dose 
G: gemcitabine; MMB: momelotinib; nab-P: nab-paclitaxel 
Three subjects will initially enroll into Dose Level 1. If no DLT occms in all 3 subjects within 
the first 28 days (Cycle 1) of treatment, 3 additional subjects will enroll into Dose Level2. 
If 1 DLT occms in any Dose Level, that Dose Level will be expanded to enroll3 additional 
subjects. If a second DLT occms within the same Dose Level after cohort expansion to 
6 subjects, the MTD of nab-P+G combined with MMB has been exceeded. Dose escalation will 
continue from Dose Level2 to 3 to 4 to 5 if no DLT occms in 3 subjects or < 2 DLTs occm in up 
to 6 subjects within each Dose Level. 
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If ≥ 2 DLTs occur in Dose Level 1, Dose Level -1 will open to enroll 3 additional subjects. If no 
DLT occurs in 3 subjects or < 2 DLTs occur in up to 6 subjects of Dose Level -1, then 
Dose Level -1 will be the MTD of nab-P+G combined with MMB. If ≥ 2 DLTs occur in 
Dose Level -1, Dose Level -2 will open to enroll 3 additional subjects.  If no DLT occurs in 
3 subjects or < 2 DLTs occur in up to 6 subjects of Dose Level -2, then Dose Level -2 will be the 
MTD of nab-P+G combined with MMB.  If ≥ 2 DLTs occur at Dose Level -2, the study will 
discontinue permanently. 
If ≥ 2 DLTs occur in Dose Level 2, 3, 4, or 5 then Dose Level 2a, 3a, 4a, or 5a will open, 
respectively.  If no DLT occurs in 3 subjects or < 2 DLTs occur in up to 6 subjects of 
Dose Level 2a, then Dose Level 3a will open to enroll 3 additional subjects. Dose escalation will 
continue from Dose Level 3a to 4a to 5a if no DLT occurs in 3 subjects or < 2 DLTs occur in up 
to 6 subjects of each Dose Level.  If ≥ 2 DLTs occur in either Dose Level 2a, 3a, 4a, or 5a, then 
Dose Level 1, 2, 3, or 4 will be the MTD of nab-P+G combined with MMB, respectively.
Please refer to Appendix 5 for flow diagram of dose escalation.
Dose limiting toxicities are based on CTCAE version 4.03. Dose limiting toxicities refer to 
toxicities experienced during the first 28 days of treatment (Cycle 1) that have been judged to be 
clinically significant and related to study treatment. A DLT is defined as:

Grade 4 neutropenia lasting > 7 days. Subjects who develop Grade 4 neutropenia during the 
first 28 days of treatment must have a repeat assessment of their neutrophil count 7 days after 
the onset of Grade 4 neutropenia to assess for this DLT.

Grade 4 neutropenia with fever (temperature 100.5º F)

Grade 4 thrombocytopenia lasting > 7 days. Subjects who develop grade 4 thrombocytopenia 
during the first 28 days of treatment must have a repeat assessment of their platelet count 
7 days after the onset of grade 4 thrombocytopenia to assess for this DLT.

Grade 3 or higher non-hematologic toxicity, excluding:
— Grade 3 nausea or emesis controlled by adequate medical therapy
— Grade 3 diarrhea controlled by adequate medical therapy
— Alopecia

A treatment-emergent AE that in the opinion of the investigator is of potential clinical 
significance such that further dose escalation would expose subjects to unacceptable risk

Any treatment delay >4 weeks that is due to study treatment-related adverse effects
After the MTD is established by the lead-in phase, the study will proceed to randomized 
treatment phase. 

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Randomized treatment: The randomized, double-blind, placebo-controlled phase of the trial. A 
total of 300 subjects will be randomized via interactive voice/web response system (IXRS) in a 
1:1 manner (150 subjects per treatment group) to either MMB or placebo in combination with 
nab-P+G. Treatment assignment of this phase will be stratified by ECOG and plasma CRP level
at diagnosis.
In both lead-in and randomized treatment phases, patient-reported outcomes (PRO), clinical, 
laboratory, and disease assessments will be completed at regular study visits as defined in 
Appendix 2. Thiamine status will be tested at baseline and every 12 weeks until EOT. CT or 
MRI scans will be performed approximately every 8 weeks to evaluate response to treatment by 
RECIST v1.1 criteria. 
3.2.
Study Treatments
The IP in this study is MMB (and its matching placebo).  MMB/placebo will be supplied by GSI.  
The formulation, packaging, and dosing regimens for the IP are further described in Section 5.
3.3.
Duration of Treatment
Subjects will continue study treatment until disease progression, unacceptable toxicity, consent 
withdrawal, or subject’s refusal of treatment. There will be a screening period of up to 21 days of 
first dose of IP (MMB) for the lead-in phase or randomization for the randomized treatment 
phase. Following treatment, subjects will be followed for safety for 30 days and for survival 
approximately every 6 months for up to 5 years.   
3.4.
Discontinuation Criteria
The study may be discontinued at any time based on periodic reviews of safety and efficacy data 
by Gilead.
Subject discontinuation criteria are described in Section 6.8.
3.5.
Source Data
The subject identification number and randomization number captured by the interactive 
voice/web response system (IXRS), as well as the patient reported outcomes data captured on 
paper are considered source data.
3.6.
Biomarker Testing
3.6.1.
Biomarker Samples to Address the Study Objectives
The following biological specimens will be collected in this study and will be used to evaluate 
the association of exploratory systemic and/or tissue specific biomarkers with study drug 
response including efficacy and/or adverse events, as well as to increase knowledge and 
understanding of the biology of related diseases and possible companion diagnostics 
development. The specific analyses will include, but will not be limited to, the biomarkers and 

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assays listed below. Because biomarker science is a rapidly evolving area of investigation, and 
adverse events in pruiicular are difficult to predict, it is not possible to specify prospectively all 
tests that will be done on the specimens provided. The testing outlined below is based upon the 
cmTent state of scientific knowledge. It may be modified during or after the end of the study to 
remove tests no longer indicated and/or to add new tests based upon the growing state of the rui 
knowledge. Biomru·ker srunples may be used for potential assay development of companion 
diagnostics. 
Biomru·ker samples will be collected from all subjects for phrumacodynamic testing and 
explorat01y analysis. 
Pharmacodynamic: The u·anscription factor STAT3 is directly phosphorylated by JAKs in 
response to cytokine stimulation. The levels ofphosph01ylated STAT3 and other 
phosphoproteins will be evaluated in samples before and after u·eatment with MMB. Modulation 
ofbiomru·kers related to JAK activation and/or MMB activity may be evaluated to fmiher 
elucidate the mechanism of action ofMMB. 
Tumor Tissue 
The following tissue samples will be collected for phrumacodynamic and explorat01y biomru·ker 
analysis: 
• 
Archival tumor tissue will be collected from all subjects. Tissue blocks will be used to 
prepru·e fresh slides. 
• 
Tumor biopsy will be perf01med at the time of the first restaging (at approximately week 8) 
on consenting subjects of a substudy of the lead-in and randomized u·eatlnent phases. 
• 
Tumor biopsy will be perf01med at the time of progression on consenting subjects of a 
second substudy of the randomized u·eatment phase. 
Blood - Plasma 
Blood will be collected from all subjects for investigating circulating cell-free tumor DNA in 
plasma before and after MMB u·eatment. Somatic mutations related to the pathophysiology of 
the disease (ie, KRAS mutation) will be explored. 
Pre-u·eatlnent CRP, IL-6 and soluble TNF receptor-alpha-2levels will be quantitated in plasma 
srunples from all subjects to assess their predictive value. Additional protein biomru·kers related 
to JAK activation and MMB activity will also be explored. 
CONFIDENTIAL 
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11 Febmaty 2014 

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Blood-RNA 
PD 
Exploratory Predictive Biomarkers for Subgroup Analysis 
PPD 
I 
I 
I 
3.6.2. 
Biomarker Samples for Optional Future Research 
PPD 
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3.6.3. 
Biomarker Samples for Optional Pharmacogenomic Research 
PD 
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4.
SUBJECT POPULATION
4.1.
Number of Subjects and Subject Selection
The number of subjects to be enrolled in lead-in phase will depend on the total number of dose 
levels that may be needed to determine the MTD and may range from 9 to 36 subjects. Once the 
MTD has been established, approximately 300 subjects will be enrolled into randomized 
treatment phase.
4.2.
Inclusion Criteria
Subjects must meet all of the following inclusion criteria to be eligible for participation in this 
study.
1) Age ≥ 18 years old
2) Initial diagnosis of metastatic pancreatic adenocarcinoma must have occurred ≤6 weeks 
prior to randomization
3) The presence of metastatic pancreatic adenocarcinoma plus 1 of the following:

Histological diagnosis of pancreatic adenocarcinoma confirmed pathologically, OR

Pathologist confirmed histological/cytological diagnosis of adenocarcinoma consistent with 
pancreas origin in conjunction with either: 
— The presence of a mass in the pancreas, OR
— A history of resected pancreatic adenocarcinoma 
4) Measurable disease per RECIST v1.1
5) Adequate organ function defined as follows:

Hepatic: Total bilirubin ≤ 1.25 x ULN; AST (SGOT) and ALT (SGPT) ≤3 x ULN

Hematological: ANC > 1500 cells/mm3, platelet > 100,000 cells/mm3, hemoglobin > 9 g/dL

Renal: Serum creatinine < 1.5 x ULN OR calculated CrCl of ≥ 60 ml/min as calculated by 
the Cockroft-Gault method
6) ECOG Performance Status of 0 or1
7) Negative serum pregnancy test for female subjects (unless surgically sterile or greater than 
two years postmenopausal)

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8) Male and female subjects of childbearing potential who engage in heterosexual intercourse 
must agree to use protocol specified method(s) of contraception as described in Appendix 3
9) Females who are nursing must agree to discontinue nursing before the first dose of IP
10) Able to comprehend and willing to sign the written informed consent form
4.3.
Exclusion Criteria
Subjects who meet any of the following exclusion criteria are not to be enrolled in this study
1) Neoadjuvant or adjuvant chemotherapy or chemoradiotherapy for pancreatic adenocarcinoma
2) Currently or previously treated with biologic, small molecule, immunotherapy, 
chemotherapy, or other agents for metastatic pancreatic carcinoma
3) Uncontrolled intercurrent illness including, but not limited to, active uncontrolled infection, 
active or chronic bleeding event within 4 weeks prior to first dose of IP, uncontrolled cardiac 
arrhythmia, or psychiatric illness/social situation that would limit compliance with study 
requirements as judged by treating physician
4) History of a concurrent or second malignancy except for adequately treated local basal cell or 
squamous cell carcinoma of the skin, cervical carcinoma in situ, superficial bladder cancer, 
asymptomatic prostate cancer without known metastatic disease and with no requirement for 
therapy or requiring only hormonal therapy and with normal prostate-specific antigen for 
≥1 year prior to randomization, adequately treated Stage 1 or 2 cancer currently in complete 
remission, or any other cancer that has been in complete remission for ≥ 5 years
5) Major surgery, defined as any surgical procedure that involves general anesthesia and a 
significant incision (ie, larger than what is required for placement of central venous access, 
percutaneous feeding tube, or biopsy), within 28 days of first dose of IP
6) Minor surgical procedure(s) within 7 days of randomization or not yet recovered from prior 
minor surgery (placement of central venous access device, fine needle aspiration, or 
endoscopic biliary stent ≥ 1 day before randomization is acceptable)
7) Known positive status for HIV
8) Chronic active or acute viral hepatitis A, B, or C infection (testing required for hepatitis B 
and C), or hepatitis B or C carrier
9) Peripheral neuropathy ≥ Grade 2
10) Known or suspected brain or central nervous system metastases

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11) Diagnosis of pancreatic islet neoplasm, acinar cell carcinoma, non-adenocarcinoma 
(ie, lymphoma, sarcoma), adenocarcinoma originating from the biliary tree or 
cystadenocarcinoma
12) History of interstitial pneumonitis
13) External biliary drain
14) Paracentesis or thoracentesis for malignant effusion within 14 days of randomization
15) Documented myocardial infarction or unstable/uncontrolled cardiac disease (ie, unstable 
angina, congestive heart failure [New York Heart Association > Class II]) within 6 months of 
randomization
16) Use of strong CYP3A4 inhibitors or strong CYP3A4 inducers within 1 week prior to the 
first dose of IP
17) Known hypersensitivity to MMB, gemcitabine and/or nab-paclitaxel, their metabolites, or 
formulation excipients
18) Uncontrolled hypertension (seated systolic blood pressure >180 mmHg or diastolic blood 
pressure >110 mmHg) at Screening
19) QTc interval > 450 msec, unless attributed to bundle branch block
20) Pregnant

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5.
INVESTIGATIONAL PRODUCTS
5.1.
Randomization, Blinding and Treatment Codes
Subjects in the randomized treatment phase will be randomized via IXRS in a 1:1 manner to 
Treatment Arm 1 or 2.

Treatment Arm 1: MMB once- or twice-daily (dose frequency as instructed by clinical 
investigator) + nab-P+G on Days 1, 8, 15, cycle repeats every 28 days

Treatment Arm 2: Placebo once- or twice-daily (dose frequency as instructed by clinical 
investigator) + nab-P+G on Days 1, 8, 15, cycle repeats every 28 days
The randomization will be stratified by ECOG performance status (0 vs. 1) and baseline CRP 
plasma level (high vs. low).
5.2.
Description and Handling of MMB
5.2.1.
Formulation
5.2.1.1.
MMB Tablets
MMB is supplied as GS-0387-01 Form II (dihydrochloride monohydrate) and is available as 
100 mg, 150 mg, and 200 mg strength (as free base equivalent) tablets. The tablets contain 
excipients, microcrystalline cellulose, lactose monohydrate, sodium starch glycolate, silicon 
dioxide, propyl gallate, magnesium stearate, polyvinyl alcohol, polyethylene glycol, talc, 
titanium dioxide, yellow iron oxide and red iron oxide. MMB tablets, 100 mg and 150 mg, are 
plain round, film-coated, brown tablets and MMB tablets 200 mg, are plain, capsule-shaped, 
film-coated, brown tablets. 
5.2.1.2.
Placebo to Match MMB Tablets (MMB PTM)
MMB PTM tablets are identical in physical appearance to the 100 mg, 150 mg, and 200 mg 
MMB tablets. The MMB PTM tablet contains the following excipients: lactose monohydrate, 
microcrystalline cellulose, croscarmellose sodium, magnesium stearate, polyvinyl alcohol, 
polyethylene glycol, talc, titanium dioxide, yellow iron oxide and red iron oxide. MMB PTM 
tablets, 100 mg and 150 mg, are plain round, film-coated, brown tablets and MMB PTM tablets 
200 mg, are plain, capsule-shaped, film-coated, brown tablets.
5.2.2.
Packaging and Labeling
MMB and MMB PTM tablets are packaged in white, high-density polyethylene bottles. Each 
bottle contains tablets, a silica gel desiccant, and polyester packing material. Each bottle is 
enclosed with a white, continuous thread, child-resistant polypropylene screw cap with an 
induction-sealed, aluminum-faced liner.

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All IP labels will meet all applicable requirements of the US FDA and Annex 13 of Good 
Manufacturing Practices: Manufacture of investigational medicinal products (July 2010) and/or 
other local regulations as applicable.
5.2.3.
Storage and Handling
MMB should be stored at controlled room temperature of 25ºC (77ºF); excursions are permitted 
between 15ºC and 30ºC (59ºF and 86ºF). 
Until dispensed to the subjects, all IP bottles should be stored in a securely locked area, 
accessible only to authorized site personnel. To ensure the stability and proper identification, the 
drug products should be stored in the containers in which they were supplied.
5.3.
Dosage and Administration 
5.3.1.
MMB and Placebo
In the randomized treatment phase, subjects will self-administer MMB/placebo orally once- or 
twice-daily. After the first dose of MMB or placebo on study, subjects will be observed for 4 
hours. 
On the day of nab-P+G administration, MMB/placebo is to be administered prior to nab-P+G.
The date and time of administration will be recorded on the respective eCRF page and in the 
source document. 
5.3.2.
Nab-paclitaxel and Gemcitabine
Nab-paclitaxel will be administered intravenously over approximately 30-40 minutes or as per 
institutional standard of care on Days 1, 8, and 15 of each 28-day cycle.  Gemcitabine will be 
administered intravenously over approximately 30 minutes or as per institutional standard of care
on Days 1, 8, and 15 of each 28-day cycle.  Administer gemcitabine immediately after 
completion of nab-paclitaxel infusion.
Body surface area used in calculating the doses of nab-paclitaxel and gemcitabine of each 
treatment cycle will be the same as the Day 1 value of that cycle, unless there is a > 10% change
in weight or height of the subject in which case the body surface area will be re-calculated based 
on the new weight and height of that subject within a cycle.
Anti-emetic prophylaxis prior to chemotherapy administration is at investigator’s discretion and 
institutional standard of care.
Dosing of nab-paclitaxel and gemcitabine will be documented in the subject eCRF. 

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5.4.
Dose Adjustment of Nab-Paclitaxel and Gemcitabine
Table 5-1.
Dose Reduction of Nab-Paclitaxel and Gemcitabine
Dose level
Nab-paclitaxel (mg/m2)
Gemcitabine (mg/m2)
Dose prior to reduction
125
1000
1st dose reduction
100
800
2nd dose reduction
75
600
Table 5-2.
Dose Modification of Nab-Paclitaxel and Gemcitabine for 
Neutropenia and/or Thrombocytopenia at Start of a Cycle or Within a 
Cycle
Cycle Day
ANC (cells/mm3)
Platelet count (cells/
mm3) 
Nab-paclitaxel/gemcitabine
Day 1
< 1,500
OR
< 100,000
Delay doses until recovery
Day 8
500 to < 1,000
OR
50,000 to < 75,000
Reduce 1 dose level
< 500
OR
< 50,000
Withhold doses
Day 15
If Day 8 doses were reduced or given without modification:
500 to < 1,000
OR
50,000 to < 75,000
Reduce 1 dose level from Day 8
< 500
OR
< 50,000
Withhold doses
Day 15
If Day 8 doses were withheld:
≤ 1,000
OR
≥ 75,000
Reduce 1 dose level from Day 1
500 to < 1,000
OR
50,000 to < 75,000
Reduce 2 dose levels from Day 1
< 500
OR
<50,000
Withhold doses
If Day 1 nab-paclitaxel dose is 100 mg/m2 and gemcitabine dose is 800 mg/m2, only 1 dose level 
reduction is allowed on Day 15.  Subjects with ANC 500 to < 1000 or platelet count 50,000 to 
< 75,000 on Day 15 will hold nab-paclitaxel and gemcitabine dosing.
Table 5-3.
Dose Modification of Nab-Paclitaxel and Gemcitabine for Other 
Adverse Drug Reactions
Adverse drug reaction
Nab-paclitaxel
Gemcitabine
Febrile neutropenia (grade 3 or 4)
Withhold until fever resolves and ANC ≥ 1,500, resume at next lower dose 
level
Peripheral neuropathy (grade 3 or 4)
Withhold until improves to ≤ Grade 1, resume at 
next lower dose level
No dose reduction
Cutaneous toxicity (Grade 2 or 3)
Reduce to next lower dose level, discontinue treatment if toxicity persists
Gastrointestinal toxicity (Grade 3 
mucositis or diarrhea)
Withhold until improves to ≤ Grade 1, resume at next lower dose level

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Pulmonary effects, sometimes severe (such as pulmonary edema, interstitial pneumonitis or adult 
respiratory distress syndrome) have been reported in association with gemcitabine therapy. The 
etiology of these effects is unknown. If such effects develop, consideration should be made to 
discontinuing gemcitabine therapy. Early use of supportive care measure may help ameliorate 
the condition.
5.5.
Dose Adjustment of MMB
Table 5-4.
MMB Dose Reduction for Thrombocytopenia 
Platelet count (cells/mm3)
MMB dose prior to dose reduction
200 mg 
twice-daily
150 mg 
twice-daily
200 mg 
once-daily
150 mg 
once-daily
100 mg 
once-daily
≥ 50,000
No dose adjustment required
≥ 25,000 to < 50,000
150 mg 
twice-daily
200 mg
once-daily
150 mg 
once-daily
100 mg 
once-daily
Interrupt treatment
< 25,000
Interrupt treatment
If thrombocytopenia is considered by investigator to be related to nab-paclitaxel and/or
gemcitabine during a treatment cycle and not by MMB in a clinically significant manner, the 
dose of MMB may be re-escalated to the dose prior to dose reduction on Day 1 of the next 
treatment cycle.
For restarting dose of MMB after dose interruption for thrombocytopenia, refer to Table 5-5.
In the event of a Grade 3 or 4 hematologic (aside from thrombocytopenia) or non-hematologic 
toxicity (aside from nausea and vomiting) that the investigator considers related to MMB and 
clinically significant, MMB will be interrupted for a maximum of 28 days until the toxicity 
resolves or returns to baseline level. Following resolution of the toxicity or the toxicity returns to 
baseline level, treatment may be restarted at a reduced dose as per Table 5-5. 
Table 5-5.
Restarting Doses of MMB After Treatment Interruption
Dose at time of toxicity
Restarting dose level
200 mg twice-daily
150 mg twice-daily
150 mg twice-daily
200 mg once-daily
200 mg once-daily
150 mg once-daily
150 mg once-daily
100 mg once-daily
100 mg once-daily
100 mg once-daily

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MMB may only be restarted after dose interruption if platelet count is ≥ 50,000 (cells/mm3).
No dose reduction of MMB below 100 mg once-daily is allowed.  If the Grade 3 or 4 
hematologic (aside from thrombocytopenia) or non-hematologic toxicity (aside from nausea and 
vomiting) considered by the investigator to be related to MMB recurs after dose reduction to 
100 mg once-daily, MMB will be discontinued permanently.
No dose reduction or interruption of MMB is allowed in the first 28 days (cycle 1) of the lead-in 
phase. 
5.6.
Restricted/Prohibited Medications
During the course of the clinical trial, subjects are anticipated to continue the use of prescribed 
medications identified during the screening procedures, consistent with study inclusion and 
exclusion criteria.
The following therapies are not permitted at any point during the trial beginning with C1D1 
(if administered, the subject may be removed from the trial):

Anti-cancer therapy, experimental or approved, other than nab-paclitaxel, gemcitabine, and 
MMB administered in this study
The following restricted medications are only permitted under the circumstances given. Each 
concomitant medication must be individually assessed against all exclusion criteria. If in doubt 
the investigator should contact the Gilead medical monitor before enrolling a patient or allowing 
a new medication to be started. 

Anti-hypertensive therapy should not be taken on the day of the first MMB dose until 4 hours 
after MMB administration

Strong CYP3A4 Inhibitors/Inducers
— MMB is partially metabolized by CYP3A4. Co-administration of strong CYP3A4
inhibitors may increase MMB exposure and caution should be exercised upon 
co-administration as dose adjustment of MMB may be required. As such, strong CYP3A4
inhibitors (eg, boceprevir, clarithromycin, fluoxetine, grapefruit juice, indinavir, 
itraconazole, ketoconazole, lopinavir/ritonavir, mibefradil, nefazodone, nelfinavir, 
posaconazole, ritonavir, saquinavir, telaprevir, telithromycin, voriconazole) may be used 
only with prior approval by Gilead.
— Co-administration of strong CYP3A4 inducers may decrease MMB. Strong CYP3A4 
inducers (eg, carbamazepine, efavirenz, nevirapine, phenytoin, rifampin, St. John’s wort) 
may be used only with prior approval by Gilead.

Breast Cancer Resistance Protein (BCRP) Substrates
— MMB was determined to be an inhibitor of BCRP with an IC50 of 2.9 μM. There is a 
potential that BCRP substrates may have higher exposure when co-administered with 
MMB.

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5.7.
Accountability for MMB or Placebo
The investigator or designee (eg, pharmacist) is responsible for ensuring adequate accountability 
of all used and unused study drugs during the study. This includes acknowledgement of receipt 
of each shipment of study drugs (quantity and condition) and tracking of study drugs 
assigned/utilized for subject dosing (eg, log). All unused study drugs dispensed to subjects must 
be returned to the site.
MMB/placebo accountability records will be provided to each study site to:

Record the date received and quantity of study drug kits.

Record the date, subject number, subject initials, the study drug kit number dispensed.

Record the date, quantity of used and unused study drug returned, along with the initials of 
the person recording the information.

Dispensing records will include the initials of the person dispensing the study drug or 
supplies.
5.7.1.
Investigational Medicinal Product Return or Disposal
The method of study drug return and destruction are described in Section 9.1.7. 

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6.
STUDY PROCEDURES
The study procedures to be conducted for each subject enrolled in the study are presented in 
tabular form in Appendix 2 and described in the text that follows. Additional information is 
provided in the study procedures manual. 
The investigator must document any deviation from protocol procedures and notify the sponsor 
or contract research organization (CRO).
6.1.
Subject Enrollment and Treatment Assignment
Subject eligibility will be established at the conclusion of the screening evaluations. The 
screening number and/or subject ID will be assigned for that individual subject by Gilead and/or 
the designated IXRS. 
It is the responsibility of the investigator to ensure that each subject is eligible for the study 
before start of treatment in lead-in phase or before randomization in randomized treatment phase. 
A subject will be considered enrolled once he or she has started treatment in lead-in or has 
completed randomization in randomized treatment. 
For randomized treatment phase of the study, subjects in both treatment arms will undergo all the 
same procedures. Details regarding randomization and treatment assignment are in Section 5.1.
6.2.
Description of Study Procedures
The sections below describe the individual study procedures outlined in subsequent sections and 
the schedule of assessments. 
6.2.1.
Informed Consent
All subjects must personally sign and date the institutional review board / independent ethics 
committee (IRB/IEC) approved informed consent form before any study procedures are 
performed. The following optional procedures will require separate subject consent either within 
the or on a separate main informed consent form, per IRB/IEC requirements:

Future research

Tumor biopsy substudies
6.2.2.
Medical History
A complete medical and surgical history will be obtained by the investigator or designee prior to 
enrollment and recorded on the electronic case report form (eCRF). 

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6.2.3.
Prior/Concomitant Medications
All outpatient medications taken within the 3 months prior to screening and during the screening 
period will be obtained prior to enrollment and recorded on the eCRF. At each study visit, the 
site will capture any and all medications taken by the subject since the last visit or during the 
visit (as applicable). Concomitant medications include prescription, non-prescription 
medications, vitamins and minerals. 
6.2.4.
Physical Examination
At screening, a complete physical examination will be performed including height and weight. 
Height and weight should be collected with the subject standing without shoes. Physical 
examination findings during the screening period will either be reported as medical history or 
AEs based on the requirements in Section 7. 
At subsequent study visits, the physical examination will be an interim examination to monitor 
for any changes, and will also include weight and assessment of disease-related clinical signs and 
symptoms. 
6.2.5.
Vital Signs
Vital signs will include pulse, systolic and diastolic blood pressure, and body temperature. Vital 
signs should be collected with the subject in a seated position for at least 5 minutes before taking 
any measurement.
6.2.6.
Electrocardiogram
A single 12-lead electrocardiogram (ECG) will be collected at the applicable study visit per 
standard practice, and will be transferred to a central reader for analysis.  The investigator will 
review all ECGs and retain the tracing with the source documents.
Following completion of a planned thorough QT study and a review of cardiovascular-related 
events, ECG monitoring may be discontinued in this study. 
6.2.7.
Laboratory Assessments
Screening laboratory samples should be obtained within 21 days prior to the first dose of IP 
(MMB) for the lead-in phase or randomization for the randomized treatment phase. Local 
laboratory CBC assessments may be collected as required for dose adjustments throughout the 
study.  Local laboratory assessments resulting in a dose change will be reported on the eCRF.
The central laboratory will be responsible for chemistry, hematology, coagulation, urinalysis, 
and serum pregnancy testing per Table 6-1 and storage of other study samples. Other tests listed 
in Table 6-1 will be performed by Gilead or a designated laboratory.  Urine pregnancy test will 
be performed by the site. Any sample collected per the Study Procedures Table (Appendix 2) 
may be analyzed for any tests necessary to ensure subject safety. Specific instructions for 
processing, labeling, and shipping samples will be provided in a central laboratory manual.  The 
date and time of sample collection will be reported to the central laboratory.

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Table 6-1.
Analytes
Chemistry
Urinalysis
Hematology and 
Coagulation
Other Analytes
Albumin
Alkaline phosphatase
ALT (SGPT)
AST (SGOT)
Amylase
Bicarbonate
BUN
Calcium
Chloride
Creatininea
CRP
GGT
Glucose
LDH
Lipase
Magnesium
Phosphorus
Potassium
Sodium
Total bilirubin
Direct bilirubin
Total protein
Uric acid
CA19-9
CEA
Color and appearance
Specific gravity
pH
Occult blood
Protein
Glucose
Bilirubin
Leukocyte esterase
Nitrite
Urobilinogen
Ketones
Microscopicc
Urine Pregnancyb
WBC
WBC differential
Basophil
Eosinophil
Lymphocyte
Monocyte
Neutrophil
Hemoglobin
Hematocrit
Platelet
ANC
PT/INR
aPTT
Serum beta hCGb
Hepatitis B surface antigen
Hepatitis B surface 
antibody
Hepatitis B core antibody
Hepatitis C antibody
Thiamine statusd
MMB PKe
MMB pharmacodynamic 
and exploratory 
biomarkersf
ANC = absolute neutrophil count; ALT = alanine aminotransferase; AST = aspartate aminotransferase; BUN = blood urea 
nitrogen; CEA=carcinoembryonic antigen; GGT = gamma-glutamyl transferase; hCG = human chorionic gonadotropin;
LDH = lactate dehydrogenase; WBC = white blood cell
a
Estimated creatinine clearance/glomerular filtration rate will be calculated based on the Cockroft-Gault formula
b
Females of child-bearing potential only. Serum pregnancy will be conducted at Screening. Urine pregnancy will be 
conducted pre-dose on Days 1 and 15 of each cycle
c
Reflex testing based on other abnormalities
d
Thiamine status may be analyzed directly in whole blood or other analyte(s)
e
Section 6.2.7.1
f
Section 3.6

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6.2.7.1. 
MMB Phannacokinetics and Phannacodynamics (all subjects) 
Final 
Original 
Intensive PK samples ofMMB and metabolites (GS-644603 and GS-642112) will be collected 
from subjects in lead-in phase on Day 1 and Day 15 of Cycle 1 (pre-MMB dose and at 0.5, 1, 
1.5, 2, 3, 4, 6, 12, and 24 homs post-MMB dose); 24 homs post-MMB dose sampling will not be 
applicable in the twice-daily cohort. 
Sparse PK samples ofMMB and metabolites (GS-644603 and GS-642112) will be collected for 
subjects in randomized u·eatment phase: u·ough samples on Day 1 of Cycles 2 and 3 at 
approximately 20 to 26 homs after the previous dose of MMB in the once-daily cohort, or at 
approximately 10 to 14 homs after the previous dose ofMMB in the twice-daily coh01i; pre-
MMB dose samples on Day 1 of Cycles 4, 5, and 6. 
The PK of nab-paclitaxel and gemcitabine may also be analyzed using these samples. 
Phrumacodynamics samples will also be collected from subjects in lead-in phase on Day 1 and 
Day 15 of Cycle 1 (pre-MMB dose and at 1, 2, 4, 6, 12, and 24 homs post-MMB dose); 24 homs 
post-MMB dose sampling will not be applicable in the twice-daily coh01i. 
6.2.7.2. 
MMB Tumor Biopsy Substudies (optional, additional consent required) 
6.2.8. 
Patient-Reported Outcomes Assessments (PRO) 
PRO will be collected for a maximum of one yeru· from randomization/baseline or until disease 
progression, whichever is eru·lier. 
6.2.8.1. 
Flmctional Assessment of Cancer Therapy - Hepatobilia1y (FACT-Hep) 
The FACT-Hep is a 45-item self-rep01i questionnaire developed to assess the quality of life of 
pancreatic cru·cinoma patients. It assesses symptoms and other health-related quality of life 
across fom dimensions (physical, sociaVfamily, emotional and functional), as well as an 18-item 
disease-specific hepatobiliruy cancer subscale. 
6.2.8.2. 
EmoQol-5D (EQ-5D) 
The EQ-5D is a general health quality of life self-report instrument that assesses five dimensions: 
mobility, self-care, usual activities, pain/discomf01i, and anxiety/depression. Each dimension has 
three levels, ranging from no health problem, moderate health problem(s), and extreme health 
problem(s). It also includes a single visual analog scale for assessment of cunent general health. 
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11 Febmaty 2014 

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6.2.9.
Disease Assessments
6.2.9.1.
Tumor Imaging (CT or MRI)
CT with contrast or MRI (for subjects who cannot tolerate CT contrast) will be obtained to 
document metastatic disease, identify target lesions as described in RECIST version 1.1, and to 
assess response and disease progression. Imaging of the chest and abdomen by CT scan with 
contrast or MRI will be performed at Screening, and every 8 weeks during the treatment period 
regardless of cycle number or dose interruption. Scans taken as part of standard medical practice 
up to 21 days prior to first dose of IP (MMB) for the lead-in phase or randomization for the 
randomized treatment phase can be used for Screening. Scans will be transferred to a central 
reader for analysis. Repeat scans may be required if the original scan is not accepted by the 
central reader, which may occur if the scan is of poor quality. CT scans may not be performed at 
sites or in countries where additional radiology approval is required, unless that approval is 
sought and granted.
The same imaging procedure and specifications (eg, contrast agent, scanner, slice thickness, etc.) 
used to define measurable target and non-target lesions must be used throughout the study for 
each subject.
6.2.9.2.
Treatment Response Assessment
Tumor burden will be characterized at baseline, and response assessments will be as per 
RECIST v1.1.  
6.2.9.3.
ECOG Performance Status
The ECOG performance status is an investigator assessment of the impact of the disease on the 
subject’s activities of daily living. It is assessed on a 6-point scale as described in Appendix 5.
6.3.
Pretreatment Assessments
6.3.1.
Screening Visit
The screening date will be defined as the date the subject signs the informed consent. Subjects 
will be screened within 21 days of first dose of IP (MMB) for the lead-in phase or randomization 
for the randomized treatment phase to determine eligibility for participation in the study. 
Screening laboratory results for pregnancy testing (females of child bearing potential), 
chemistry, hematology, coagulation and urinalysis should be obtained from central laboratory 
and meet all eligibility criteria in order for a subject to be enrolled. Subjects who do not enroll 
within the 21 day screening window will be screen failed. Re-screening is allowed. 
The following will be performed and documented at screening:

Obtain written informed consent

Obtain medical history, including prior/concomitant medication review

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
Complete physical examination including body weight and height

Vital Signs

Single 12-lead ECG

ECOG performance status

Laboratory assessments 
— Chemistry
— Complete blood count (CBC) with differential
— Coagulation
— Hepatitis testing
— Serum pregnancy test (females of child-bearing potential)
— Urinalysis

CT scan with contrast or MRI (scans taken as part of standard medical practice up to 21 days 
prior to first dose of IP (MMB) for the lead-in phase or randomization for the randomized 
treatment phase are acceptable)

Record any adverse events (occurring after signing of the consent form)

Complete/enter IXRS subject/visit information 
Subjects meeting all of the inclusion criteria and none of the exclusion criteria will return to the 
clinic within 21 days after screening for enrollment/randomization into the study.
From the time of obtaining informed consent through the first administration of IP, record all 
serious adverse events (SAEs), as well as any adverse events related to protocol-mandated 
procedures on the adverse events case report form (CRF/eCRF). All other untoward medical 
occurrences observed during the screening period, including exacerbation or changes in medical 
history are to be captured on the medical history CRF/eCRF.  See section 7 Adverse Events and 
Toxicity Management for additional details.
6.3.2.
Subject Randomization 
In randomized treatment phase a subject will be considered enrolled once the site has completed 
the IXRS randomization module. IXRS will be utilized to assign IP at the time of randomization. 
Details regarding randomization and treatment assignment are in Section 5.1. 
The site will train the subject on the dosing schedule for the IP and the dosing diary at the time of 
dispensing. Baseline visit/Cycle 1 Day 1 (C1D1) may occur within 3 business days following 
randomization. 

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6.3.3.
Baseline Visit / C1D1 
Subjects who have met all eligibility criteria will return to the clinic on C1D1 to perform 
baseline assessments. C1D1 is defined as the date of the first dose of IP. 
The following baseline assessments will be conducted prior to the first dose of 
MMB/placebo + nab-P+G:

Physical examination, including weight

Vital signs (pre- and post- first MMB dose on C1D1 every 2 hours for 4 hours)

PROs
— FACT-Hep
— EQ-5D

Single 12-lead ECG

ECOG performance status

Laboratory assessments and blood sampling (refer to Appendix 2)
— Chemistry
— CBC with differential
— Coagulation
— Thiamine status
— Baseline MMB PK and pharmacodynamics (in lead-in phase only)
— MMB pharmacodynamic and exploratory biomarkers sampling
— Request archival tumor tissue specimen as applicable: Efforts to acquire tissue sample 
should begin on C1D1
— Urinalysis
— Urine pregnancy test, if applicable

Record any adverse events 

Concomitant medications review

IP accountability and dispensing as assigned by IXRS

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6.4.
Treatment Assessments
Each on-study visit will be scheduled relative to Day 1. Visits will follow the Study Procedures 
Table in Appendix 2.
6.4.1.
Days 1 of Subsequent Cycles, Days 8 and 15
On-study visits during the treatment period may be completed within a window of 3 business
days. The following procedures will be completed pre-dose on Days 1, 8 and 15 of each cycle, 
unless otherwise specified:

Physical examination, including weight (Days 1 only)

Vital signs

PROs (Days 1 only)
— FACT-Hep
— EQ-5D

Single 12-lead ECG (approximately every 2 weeks for the first 3 cycles, then on Day 1 of 
each subsequent cycle)

ECOG performance status

Laboratory assessments and blood sampling (refer to Appendix 2)
Chemistry 
CBC with differential
Coagulation (every 12 weeks)
Thiamine Status (every 12 weeks) 
MMB PK
MMB pharmacodynamic and exploratory biomarkers sampling
Tumor biopsy (after Cycle 2 at approximately week 8 or at disease progression for 
substudy subjects only)
Urinalysis (Days 1 only)
Urine pregnancy test (if applicable, Days 1 only)

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
CT with contrast or MRI (approximately every 8 weeks ± 3 days regardless of cycle number 
or dose interruption; use same procedure throughout study)

Record any adverse events 

Concomitant medications review

Enter IP assigned and/or subject status/information (as applicable) into IXRS

IP accountability and dispensing by IXRS (as applicable)
6.4.2.
End of Treatment (EOT) Visit
Subjects who discontinue the study treatment regardless of the reason must have EOT visit on 
the day of study treatment discontinuation with a window of 7 days and prior to initiating a 
new anti-cancer regimen. The following procedures will be conducted: 

Physical examination, including weight

Vital signs (pre-dose only)

PROs
— FACT-Hep
— EQ-5D

Single 12-lead ECG

ECOG performance status

Laboratory assessments and blood sampling
— Chemistry
— CBC with differential
— Coagulation
— MMB pharmacodynamics and exploratory biomarkers sampling
— Urinalysis
— Urine pregnancy test (if applicable)

CT with contrast or MRI (± 3 days; use same procedure throughout study, not necessary if 
restaging scan was performed within the prior 8 weeks)

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
Record any adverse events 

Concomitant medications review

IP accountability
6.5.
Unscheduled visits
Unscheduled visits may occur at any time during the study. Vital signs, laboratory assessments, 
ECG, and PE may be conducted at these visits. 
6.6.
Post-treatment Follow-up Assessments
After discontinuing treatment, subjects will complete the 30-day safety follow-up visit and will 
be contacted via phone call every 6 months for up to 5 years. 
6.6.1.
30-Day Safety Follow-up Visit
The following procedures will be completed 30 days after the subject’s last dose of IP, within a 
window of 7 days:

Physical examination, including weight

Vital signs

PROs
— FACT-Hep
— EQ-5D

ECOG performance status

Laboratory assessments
— Chemistry
— CBC with differential
— Coagulation
— Urinalysis

Concomitant medications review

Record any adverse events (30 days post last dose of IP)

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6.6.2.
5-Year Long Term Survival Follow-Up
Subjects will be contacted via phone call every 6 months for determination of long term survival 
status and record of any other anti-cancer therapy for up to 5 years after the last dose of IP.
Subjects who are not deceased by the time GSI has made the determination the study will be 
ended will receive a final follow-up phone call to assess survival status and communicate the 
Sponsor’s decision. These subjects will be censored on the date the subject was last contacted.
The investigator will make every effort to contact the subject or a close relative or caretaker by 
phone to collect survival information. The investigator should show due diligence by 
documenting in the source documents steps taken to contact the subject i.e., dates of phone calls, 
registered letters, etc.
6.7.
Withdrawal from Treatment, Procedures, and Study 
6.7.1.
Subjects’ Decision to Withdraw
Subjects have the right to withdraw from the study at any time and for any reason without 
prejudice to their future medical care by the physician or at the institution.
Subjects (or a legally acceptable representative) can decline to continue receiving investigational 
product and/or other protocol-required treatment or procedures at any time during the study but 
continue participation in the study. If this occurs, the investigator is to discuss with the subject 
the appropriate processes for discontinuation from the IP and must discuss with the subject the 
options for continuation of the scheduled procedures (Appendix 2) and collection of data, 
including endpoints and adverse events. The investigator must document the change to the Study 
Procedures Table (Appendix 2) and the level of follow-up that is agreed to by the subject (eg. in 
person, by phone/mail, through family/friends, in correspondence/communication with other 
physicians, from review of the medical records). 
Withdrawal of consent for a study means that the subject does not wish to receive further 
protocol-required treatment or procedures, and the subject does not wish to or is unable to 
continue further study participation. Subject data up to withdrawal of consent will be included in 
the analysis of the study, and where permitted, publically available data can be included after 
withdrawal of consent. The investigator is to discuss with the subject appropriate procedures for 
withdrawal from the study. 
6.7.2.
Investigator or Sponsor Decision to Withdraw or Terminate Subjects’ 
Participation Prior to Study Completion
The investigator and/or GSI can decide to withdraw a subject(s) from IP and/or other 
protocol-required treatment, protocol procedures, or the study as a whole at any time prior to 
study completion. 

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MMB is currently under investigation for the treatment of pancreatic adenocarcinoma. When the 
study ends or in the event that the study is prematurely terminated by GSI for reasons other than 
for safety, and results of the study support continuing development of MMB for pancreatic 
adenocarcinoma, decisions on the continual provision of treatment for subjects that the 
investigator deems is receiving a clinical benefit will be made on a case-by-case basis. MMB 
may be provided to these eligible subjects to continue treatment until it is commercially available 
unless there are emerging safety concerns or manufacturing issues.  
6.8.
Criteria for Discontinuation from Treatment or Study 
6.8.1.
Criteria for Discontinuation from Treatment
The reason for discontinuation from treatment will be recorded on the EOT CRF. Study 
treatment may be discontinued for any of the following reasons:

Intercurrent illness that would, in the judgment of the investigator, affect assessments of 
clinical status to a significant degree 

Toxicity that, in the judgment of the investigator, compromises the ability to continue 
study-specific procedures or is considered to not be in the subject’s best interest

Disease progression (based on investigator assessment of baseline and post-baseline scans as 
per RECIST v1.1)

Subject request to discontinue treatment for any reason

Subject noncompliance

Initiation of systemic anti-neoplastic therapy other than treatments per protocol in the 
absence of progression

Discontinuation of the study treatment at the request of GSI, a regulatory agency or an 
institutional review board or independent ethics committee (IRB/IEC)

Pregnancy during treatment; refer to Appendix 3
If a subject has discontinued the study treatment due to toxicity, he/she should not have 
withdrawal of consent recorded as the reason for discontinuation. Instead, the reason for 
discontinuation must be recorded as due to adverse drug reaction. 
Every attempt should be made to keep the subject in the study and continue collecting CT or 
MRI scans for tumor assessment at every 8 weeks until disease progression or initiation of 
systemic anti-tumor therapy other than treatment per protocol. If this is not possible or 
acceptable to the subject or investigator, the subject may be withdrawn from the study. The 
subject will be asked to attend the post-treatment follow-up assessment visit above when 
discontinuing from the study. 

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6.8.2.
Criteria for Discontinuation from Study
Subjects may voluntarily withdraw from the study or be dropped from it at the discretion of the 
investigator at any time. 
As a general rule, if a subject discontinue study treatment and later is withdrawn from the study 
or completes the study follow-up, the reasons may include the following:

Withdrawal of consent from study

Lost to follow-up

Death

Investigator’s decision to remove the subject from the study, in consultation with the Gilead 
Medical Monitor

Discontinuation of the study at the request of GSI, a regulatory agency or an institutional 
review board or independent ethics committee (IRB/IEC)

Pregnancy during the study; refer to Appendix 3
6.9.
Protocol Deviations
GSI’s policy prohibits exemptions from protocol inclusion/exclusion criteria.  In the event of a 
significant deviation related to gross non-compliance from the protocol or incidences that impose 
significant risk to subject safety, the investigator or designee must notify GSI and/or its designee 
immediately. The site will be required to document deviations in accordance with GSI’s 
procedures and in accordance with the site’s procedures and processes.
6.10.
End of Study
End of study for a subject is defined as the date of the last study-related procedure or the date of 
death for an on-study subject.

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7.
ADVERSE EVENTS AND TOXICITY MANAGEMENT
7.1.
Definitions of Adverse Events, Adverse Reactions, and Serious Adverse 
Events
7.1.1.
Adverse Events
An adverse event (AE) is any untoward medical occurrence in a clinical study subject 
administered a medicinal product, which does not necessarily have a causal relationship with the
treatment. An AE can therefore be any unfavorable and/or unintended sign, symptom, or disease 
temporally associated with the use of a medicinal product, whether or not considered related to 
the medicinal product. AEs may also include pre- or post-treatment complications that occur as a 
result of protocol specified procedures, lack of efficacy, overdose, drug abuse/misuse reports, or 
occupational exposure. Preexisting events that increase in severity or change in nature during or 
as a consequence of participation in the clinical study will also be considered AEs.
An AE does not include the following:

Medical or surgical procedures such as surgery, endoscopy, tooth extraction, and transfusion.
The condition that led to the procedure may be an adverse event and must be reported.

Pre-existing diseases, conditions, or laboratory abnormalities present or detected before the 
screening visit that do not worsen

Situations where an untoward medical occurrence has not occurred (eg, hospitalization for 
elective surgery, social and/or convenience admissions)

Overdose without clinical sequelae (see Section 7.7.1)

Any medical condition or clinically significant laboratory abnormality with an onset date 
before the consent form is signed and not related to a protocol-associated procedure is not an 
AE. It is considered to be pre-existing and should be documented on the medical history 
CRF.
7.1.2.
Serious Adverse Events
A serious adverse event (SAE) or serious adverse drug reaction (SADR) is defined as an event 
that, at any dose, results in the following:

Death

Life-threatening (Note: The term “life-threatening” in the definition of “serious” refers to an 
event in which the subject was at risk of death at the time of the event; it does not refer to an 
event that hypothetically might have caused death if it were more severe.)

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
In-patient hospitalization or prolongation of existing hospitalization

Persistent or significant disability/incapacity

A congenital anomaly/birth defect

A medically important event or reaction: such events may not be immediately life-
threatening or result in death or hospitalization but may jeopardize the subject or may require 
intervention to prevent one of the other outcomes constituting SAEs. Medical and scientific 
judgment must be exercised to determine whether such an event is a reportable under 
expedited reporting rules. For the avoidance of doubt, infections resulting from contaminated 
medicinal product will be considered a medically important event and subject to expedited 
reporting requirements.  Examples of medically important events include:
— Intensive treatment in an emergency room or at home for allergic bronchospasm
— Blood dyscrasias or convulsions that do not result in hospitalization 
— Development of drug dependency or drug abuse 
7.1.2.1.
Protocol-Specific Serious Adverse Event Instructions
To maintain the integrity of the study, the following events that are assessed as unrelated to IP 
will not be considered as SAE:

Progression of pancreatic carcinoma

Death related to progression of pancreatic carcinoma
However, events of progression of pancreatic carcinoma and death related to progression of 
pancreatic carcinoma that are assessed by the investigator to be related to study drug will be 
considered as SAE and will be reported to regulatory agencies in an expedited fashion by GSI.
All events of progression of pancreatic carcinoma and death related to progression of pancreatic 
carcinoma, regardless of investigator assessment of relationship to IP, will be reported in the 
eCRFs and, as appropriate, in the final clinical study report and in any relevant aggregate safety 
reports.
7.1.3.
Clinical Laboratory Abnormalities and Other Abnormal Assessments as 
Adverse Events or Serious Adverse Events
Laboratory abnormalities without clinical significance are not recorded as AEs or SAEs. 
However, laboratory abnormalities (eg, clinical chemistry, hematology, coagulation, and 
urinalysis) that require medical or surgical intervention or lead to IP interruption, modification, 
or discontinuation must be recorded as an AE, as well as an SAE, if applicable. In addition, 
laboratory or other abnormal assessments (eg, electrocardiogram, x-rays, vital signs) that are 

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associated with signs and/or symptoms must be recorded as an AE or SAE if they meet the 
definition of an AE or SAE as described in Sections 7.1.1and 7.1.2. If the laboratory abnormality 
is part of a syndrome, record the syndrome or diagnosis (eg, anemia), not the laboratory result 
(ie, decreased hemoglobin).
For specific information on handling of clinical laboratory abnormalities in this study, please 
refer to Section 7.5.
7.2.
Assessment of Adverse Events and Serious Adverse Events
The investigator or qualified subinvestigator is responsible for assessing AEs and SAEs for 
causality and severity, and for final review and confirmation of accuracy of event information 
and assessments.
7.2.1.
Assessment of Causality for Study Drugs and Procedures
The investigator or qualified subinvestigator is responsible for assessing the relationship to IP
therapy using clinical judgment and the following considerations:

No: Evidence exists that the adverse event has an etiology other than the IP. For SAEs, an 
alternative causality must be provided (eg, pre-existing condition, underlying disease, 
intercurrent illness, or concomitant medication).

Yes: There is reasonable possibility that the event may have been caused by the 
investigational medicinal product.
It should be emphasized that ineffective treatment should not be considered as causally related in 
the context of adverse event reporting. 
The relationship to study procedures (eg, invasive procedures such as venipuncture or biopsy) 
should be assessed using the following considerations:

No: Evidence exists that the adverse event has an etiology other than the study procedure.

Yes: The adverse event occurred as a result of protocol procedures, (eg, venipuncture)
7.2.2.
Assessment of Severity
The severity of AEs will be graded using the Common Terminology Criteria for Adverse Events 
(CTCAE), Version 4.03 in study manual and available at 
http://evs.nci.nih.gov/ftp1/CTCAE/CTCAE_4.03_2010-06- 14_QuickReference_8.5x11.pdf). 
For each episode, the highest severity grade attained should be reported.
If a CTCAE criterion does not exist, the investigator should use the grade or adjectives: Grade 1 
(mild), Grade 2 (moderate), Grade 3 (severe), Grade 4 (life-threatening), or Grade 5 (fatal) to 
describe the maximum intensity of the AE. For purposes of consistency with the CTCAE, these 
intensity grades are defined in Table 7-1.

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Table 7-1.
Grading of Adverse Event Severity
Grade
Adjective
Description 
Grade 1 
Mild
Sign or symptom is present, but it is easily tolerated, is not expected to have a 
clinically significant effect on the subject’s overall health and well-being, does 
not interfere with the subject’s usual function, and is not likely to require 
medical attention. 
Grade 2 
Moderate
Sign or symptom causes interference with usual activity or affect clinical status, 
and may require medical intervention. 
Grade 3 
Severe
Sign or symptom is incapacitating or significantly affects clinical status and 
likely requires medical intervention and/or close follow-up. 
Grade 4 
Life-threatening
Sign or symptom results in a potential threat to life. 
Grade 5 
Fatal
Sign or symptom results in death. 
The distinction between the seriousness and the severity of an AE should be noted. Severe is a 
measure of intensity; thus, a severe reaction is not necessarily a serious reaction. 
7.3.
Investigator Requirements and Instructions for Reporting Adverse Events 
and Serious Adverse Events to Gilead or CRO
All SAEs, regardless of cause or relationship, that occur after the subject first consents to 
participate in the study (ie, signing the informed consent) and throughout the duration of the 
study, including the protocol-required post treatment follow-up period, must be reported to the 
CRF/eCRF database and GSI Drug Safety and Public Health (DSPH) as instructed. This also 
includes any SAEs resulting from protocol-associated procedures performed after informed 
consent is signed.
Investigators are not obligated to actively seek SAEs after the protocol defined 30-day follow up 
period.  However, if the investigator learns of any SAEs that occur after study participation has 
concluded and the event is deemed relevant to the use of IP, he/she should promptly document 
and report the event to Gilead DSPH.

All AEs and SAEs will be recorded in the CRF/eCRF database within the timelines outlined 
in the CRF/eCRF completion guideline.

At the time of study start, SAEs will be reported using a paper serious adverse event 
reporting form. During the study conduct, sites may transition to an electronic SAE (eSAE) 
system. GSI will notify sites in writing and provide training and account information prior to 
implementing an eSAE system.

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Serious Adverse Event Paper Reporting Process
All SAEs will be recorded on the serious adverse event report form and submitted by faxing or 
emailing the report form within 24 hours of the investigator’s knowledge of the event to the 
attention of Gilead DSPH.
Electronic Serious Adverse Event (eSAE) Reporting Process
Site personnel record all SAE data in the eCRF database and from there transmit the SAE 
information to Gilead DSPH within 24 hours of the investigator’s knowledge of the event. 
Detailed instructions can be found in the eCRF completion guidelines.

If for any reason it is not possible to record the SAE information electronically, ie, the eCRF 
database is not functioning, record the SAE on the paper serious adverse event reporting 
form and submit within 24 hours as described above.

As soon as it is possible to do so, any SAE reported via paper must be transcribed into the 
eCRF Database according to instructions in the eCRF completion guidelines.

If an SAE has been reported via a paper form because the eCRF database has been locked, no 
further action is necessary.

For fatal or life-threatening events, copies of hospital case reports, autopsy reports, and other 
documents are also to be submitted by e-mail or fax when requested and applicable. 
Transmission of such documents should occur without personal subject identification, 
maintaining the traceability of a document to the subject identifiers.

Additional information may be requested to ensure the timely completion of accurate safety 
reports.

Any medications necessary for treatment of the SAE must be recorded onto the concomitant 
medication section of the subject’s CRF/eCRF and the event description section of the SAE 
form.
7.4.
Gilead Reporting Requirements
Depending on relevant local legislation or regulations, including the applicable US FDA Code of 
Federal Regulations, the EU Clinical Trials Directive (2001/20/EC) and relevant updates, and 
other country-specific legislation or regulations, GSI may be required to expedite to worldwide 
regulatory agencies reports of SAEs, serious adverse drug reactions (SADRs), or suspected 
unexpected serious adverse reactions (SUSARs). In accordance with the EU Clinical Trials 
Directive (2001/20/EC), Gilead or a specified designee will notify worldwide regulatory 
agencies and the relevant IEC in concerned Member States of applicable SUSARs as outlined in 
current regulations.
Gilead DSPH:
Fax:1-650-522-5477 
E-mail: Safety_fc@gilead.com 

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Assessment of expectedness for SAEs will be determined by Gilead using reference safety 
information specified in the investigator’s brochure or relevant local label as applicable. 
All investigators will receive a safety letter notifying them of relevant SUSAR reports associated 
with any study IP. The investigator should notify the IRB or IEC of SUSAR reports as soon as is 
practical, where this is required by local regulatory agencies, and in accordance with the local 
institutional policy. 
7.5.
Clinical Laboratory Abnormalities and Other Abnormal Assessments as 
Adverse Events or Serious Adverse Events
Laboratory abnormalities are usually not recorded as AEs or SAEs. However, laboratory 
abnormalities (eg, clinical chemistry, hematology, coagulation, and urinalysis) that require 
medical or surgical intervention or lead to IP interruption or discontinuation must be recorded as 
an AE, as well as an SAE, if applicable. If the laboratory abnormality is part of a syndrome, 
record the syndrome or diagnosis (eg, anemia) not the laboratory result (ie, decreased 
hemoglobin).
Severity should be recorded and graded according to the CTCAE Version 4.03.
For AEs associated with laboratory abnormalities, the event should be graded on the basis of the 
clinical severity in the context of the underlying conditions; this may or may not be in agreement 
with the grading of the laboratory abnormality.
7.6.
Toxicity Management 
Dosing requirements for certain toxicities are specified in Section 5.3. The investigator may 
contact the Medical Monitor to review toxicities that are not directly discussed in the protocol.
7.7.
Special Situations Reports
7.7.1.
Definitions of Special Situations
Special situation reports include all reports of medication error, abuse, misuse, overdose, reports 
of adverse events associated with product complaints, and pregnancy reports regardless of an 
associated AE.  
Medication error is any unintentional error in the prescribing, dispensing, or administration of a 
medicinal product while in the control of the health care provider, subject, or consumer.
Abuse is defined as persistent or sporadic intentional excessive use of a medicinal product by a 
subject.
Misuse is defined as any intentional and inappropriate use of a medicinal product that is not in 
accordance with the protocol instructions or the local prescribing information.
An overdose is defined as an accidental or intentional administration of a quantity of a medicinal 
product given per administration or cumulatively which is above the maximum recommended 
dose as per protocol or in the product labelling (as it applies to the daily dose of the subject in 

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question). In cases of a discrepancy in drug accountability, overdose will be established only 
when it is clear that the subject has taken the excess dose(s). Overdose cannot be established 
when the subject cannot account for the discrepancy except in cases in which the investigator has 
reason to suspect that the subject has taken the additional dose(s).
Product complaint is defined as complaints arising from potential deviations in the manufacture, 
packaging, or distribution of the medicinal product.  
7.7.2.
Instructions for Reporting Special Situations
7.7.2.1.
Instructions for Reporting Pregnancies
The investigator should report pregnancies in female study subjects that are identified after 
initiation of study medication and throughout the study, including the post study drug follow-up 
period, to Gilead DSPH using the pregnancy report form within 24 hours of becoming aware of 
the pregnancy.
Refer to Section 7.3 and the CRF/eCRF completion guidelines for full instructions on the 
mechanism of pregnancy reporting.
The pregnancy itself is not considered an AE nor is an induced elective abortion to terminate a 
pregnancy without medical reasons.
Any premature termination of pregnancy (eg, a spontaneous abortion, an induced therapeutic 
abortion due to complications or other medical reasons) must be reported within 24 hours as an 
SAE. The underlying medical reason for this procedure should be recorded as the AE term.
A spontaneous abortion is always considered to be an SAE and will be reported as described in 
sections 7.1.1 and 7.1.2. Furthermore, any SAE occurring as an adverse pregnancy outcome post 
study must be reported to Gilead DSPH. 
The subject should receive appropriate monitoring and care until the conclusion of the 
pregnancy. The outcome should be reported to Gilead DSPH using the pregnancy outcome report 
form. If the end of the pregnancy occurs after the study has been completed, the outcome should 
be reported directly to Gilead DSPH. Gilead DSPH contact information is as follows: 
Email: Safety_FC@gilead.com or Fax: +1 (650) 522-5477. 
Pregnancies of female partners of male study subjects exposed to MMB or other study drugs 
must also be reported and relevant information should be submitted to GSI DSPH using the 
pregnancy and pregnancy outcome forms within 24 hours. Monitoring of the subject should 
continue until the conclusion of the pregnancy. If the end of the pregnancy occurs after the study 
has been completed, the outcome should be reported directly to Gilead DSPH.Gilead DSPH 
contact information is as follows: Email: Safety_FC@gilead.com or Fax: +1 (650) 522-5477.
Refer to Appendix 3 for Pregnancy Precautions, Definition for Female of Childbearing Potential, 
and Contraceptive Requirements.

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7.7.2.2.
Emergency Unblinding
In the event of a medical emergency where breaking of the blind is being considered by the 
treating physician, the investigator may break the blind using the IVRS. It is recommended that 
the GSI Medical Monitor be contacted before the investigator breaks the blind. Please note that 
the treatment assignment should not be unblinded if unblinding will not affect the way the 
subject would be treated. In the event of a medical emergency, where breaking of the blind is 
required per the medical judgment of the investigator, the GSI Medical Monitor must be 
contacted as soon as possible after the unblinding. The unblinding must be clearly justified and 
explained by a comment in the source documentation, along with the date on which the code was 
broken and the identity of the person authorizing the unblinding.
Blinding of study treatment is critical to the integrity of this clinical trial and therefore, if a 
subject’s treatment assignment is disclosed to the investigator, the subject will have study 
treatment discontinued. All subjects will be followed until study completion unless consent to do 
so is specifically withdrawn by the subject.
GSI DSPH may independently unblind cases for expedited reporting of SUSARs.
7.7.2.3.
Reporting Other Special Situations
All other special situation reports must be reported on the special situations report form and 
forwarded to Gilead DSPH within 24 hours of the investigator becoming aware of the situation. 
These reports must consist of situations that involve study IP and/or Gilead concomitant 
medications, but do not apply to non-GSI concomitant medications. 
Special situations involving non-Gilead concomitant medications does not need to be reported on 
the special situation report form; however, for special situations that result in AEs due to a 
non-GSI concomitant medication, the AE should be reported on the AE form. 
Any inappropriate use of concomitant medications prohibited by this protocol should not be 
reported as “misuse,” but may be more appropriately documented as a protocol deviation.
Refer to Section 7.3 and the CRF/eCRF completion guidelines for full instructions on the 
mechanism of special situations reporting.
All clinical sequelae in relation to these special situation reports will be reported as AEs or SAEs 
at the same time using the AE CRF/eCRF and/or the SAE report form. Details of the symptoms 
and signs, clinical management, and outcome will be reported, when available.

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8.
STATISTICAL CONSIDERATIONS
The methods specified here pertain to the randomized treatment portion of the study. Similar 
descriptive methods will be used to characterize the data from subjects in the non-randomized 
lead-in phase of the study.
In general, count and percent of subjects will summarize categorical and ordinal data. Mean, 
standard deviation, minimum, quartiles, median, and maximum will summarize continuous data, 
Kaplan-Meier (KM) cross product method will summarize time-to-event data. 
8.1.
Analysis Objectives and Endpoints
8.1.1.
Analysis Objectives
The primary objectives of this study are:

Lead-in phase: To evaluate the safety, pharmacokinetics, and define the MTD of MMB 
combined with nab-P+G in subjects with previously untreated metastatic pancreatic ductal 
adenocarcinoma

Randomized treatment phase: To determine the efficacy of nab-P+G combined with either 
MMB or placebo in subjects with previously untreated metastatic pancreatic ductal 
adenocarcinoma as measured by improvement in overall survival (OS).
8.1.2.
Primary Endpoint
Lead-in: Incidence of DLT as defined in Section 5.3.
Randomized treatment: Overall survival (OS), defined as the interval from randomization to 
death from any cause 
8.1.3.
Secondary Endpoint
Lead-in:

Overall survival (OS) – defined as the interval from first dose date of IP in lead-in phase to 
death from any cause.

Progression free survival (PFS) – defined as the interval from first dose date of IP in lead-in 
phase to the earlier of the first documentation of definitive disease progression or death from 
any cause; definitive disease progression is progression based on RECIST criteria v1.1. Data 
from survival, non-progressing subjects will be censored at the earliest of the time of 
initiation of anti-tumor therapy other than the study treatment or the last time that lack of 
definitive disease progression was objectively documented while on study.

Objective response rate (ORR) - defined as the proportion of subjects who achieve a 
Complete Response (CR) or Partial Response (PR) as assessed by RECIST v1.1.

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Randomized u·eatment: Progression free smvival (PFS) and objective response rate (ORR). 
• 
Progression free survival (PFS) - defmed as the interval from randomization to the earlier of 
the first documentation of defmitive disease progression or death from any cause; definitive 
disease progression is progression based on RECIST vl.l criteria. Data from smvival, 
non-progressing subjects will be censored at the earliest of the time of initiation of anti-tumor 
therapy other than the study u·eatment or the last time that lack of defmitive disease 
progression was objectively documented while on study. 
• 
Objective response rate (ORR) - defmed as the prop01iion of subjects who achieve a 
Complete Response (CR) or Partial Response (PR) as assessed by RECIST vl.l. 
8.1.4. 
Exploratory Endpoints 
Explorat01y endpoints for randomized u·eatment phase are: 
PPO 
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8.2.
Analysis Conventions
8.2.1.
Analysis Sets
8.2.1.1.
Intent-to-Treat (ITT) Analysis Set
The Intent-to-Treat (ITT) Analysis Set consists of all randomized subjects regardless of whether 
subjects receive any study drug. Following the ITT principle, subjects are analyzed according to 
the treatment they are assigned to at randomization.
The ITT Analysis Set will be used for demographic and baseline characteristics, medical and 
disease history, and efficacy analyses. The analysis of OS based on the ITT Analysis Set will be 
considered the primary analysis of the study. Subjects in the ITT Analysis Set will be considered 
the primary analysis of the study. Subjects in the ITT Analysis Set who do not have sufficient 
baseline or on-study tumor status information to be adequately assessed for response status will 
be included in the denominators in the calculation of response rates.
8.2.1.2.
Per-Protocol (PP) Analysis Set
The Per-Protocol (PP) Analysis Set consists of all subjects in the ITT Analysis Set who meet the 
general criteria defining the target population for this study, are adherent to the protocol, 
compliant with study drug, and are evaluable for relevant efficacy endpoints. Study treatment 
assignment will be designated according to the actual treatment received. The specific 
classification of subjects to be excluded from the PP Analysis Set will be included in the 
statistical analysis plan (SAP) and finalized prior to database lock.
The PP Analysis Set will be used in sensitivity analyses of the primary and secondary endpoints 
as needed.
8.2.1.3.
Safety Analysis Set
The Safety Analysis Set consists of subjects in the ITT Analysis Set who received ≥ 1 dose of 
study drug, with study treatment assignment designated according to the actual treatment 
received.
The Safety Analysis Set will be used in the analyses of safety variables, study treatment 
administration and compliance.
8.2.1.4.
Pharmacodynamic and Pharmacokinetic (PK) Analysis Sets
The Pharmacodynamic and PK Analysis Sets consist of all subjects in the Safety Analysis Set 
who have the necessary baseline and on-study measurements to provide interpretable results for 
the specific parameters of interest.
8.3.
Data Handling Conventions
Unless otherwise specified, data from the lead-in and randomized treatment parts will be 
summarized and analyzed separately.

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By-subject listings will be created for important variables from each eCRF module. Summary 
tables for continuous variables will contain the following statistics: N (number in population), 
n (number with data), mean, standard deviation (StD), 95% confidence intervals (CIs) on the 
mean, median, minimum, and maximum. Summary tables for categorical variables will include: 
N, n, percentage, and 95% CIs on the percentage. Unless otherwise indicated, 95% CIs for binary 
variables will be calculated using the binomial distribution (exact method) and will be 2-sided. 
Data will be described and summarized by relevant treatment arm, analysis set, and timepoint. 
As appropriate, changes from baseline to each subsequent timepoint will be described and 
summarized by treatment arm. Similarly, as appropriate, the best change from baseline during 
the study will also be described and summarized by treatment arm. Graphical techniques 
(eg, waterfall plots, Kaplan-Meier curves, line plots) may be used when such methods are 
appropriate and informative.
The baseline value will be the last (most recent) pre-treatment value in safety analyses and the 
last (most recent) pre-randomization value for efficacy analyses. Subjects with discrepancies 
between the stratification factor values at randomization and the actual values as documented on 
data review will be categorized in the analyses according to the actual values. In the situation 
that there is insufficient information in a stratum (ie, if there are <6 subjects or there is no 
informative event in a stratum), that stratum will be pooled with the smallest adjacent stratum for 
stratified analyses; the smallest stratum is defined as that stratum having the fewest number of 
subjects or the fewest number of events in case the former is a tie and the adjacent stratum is 
defined as a stratum having one factor of the 2 at the same level. Data from all sites will be 
pooled for all analyses. Analyses will be based upon the observed data unless methods for 
handling missing data are specified. If there is a significant degree of non-normality, analyses 
may be performed on log-transformed data or nonparametric tests may be applied, as 
appropriate.
Unless otherwise specified, all analyses will be 2-sided at the 0.05 level of significance.
The following censoring conventions will be applied for time-to-event endpoints:

OS: Data from surviving subjects will be censored at the last time that the subject was known 
to be alive.

PFS and DOR: Data from surviving, non-progressing subjects will be censored at the earliest 
of the time of initiation of anti-tumor therapy other than the study treatment or the last time 
that lack of definitive progression was objectively documented. Data from subjects who have 
disease progression or die after ≥ 2 consecutive missing tumor assessments or after the 
initiation of anti-tumor therapy other than the study treatment will be censored at the last 
time prior to the missing assessments that lack of definitive progression was objectively 
documented or at the time of initiation of anti-tumor therapy other than the study treatment, 
whichever is earlier. If a subject does not have a baseline tumor assessment, then the PFS 
time will be censored at the randomization date, regardless of whether or not definitive 
disease progression or death has been observed. 

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Demographic Data and Baseline Characteristics 
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Subject demographic and baseline characteristics will be listed and summarized by treatment rum 
for the ITT Analysis Set. Imbalances in subject characteristics may be compared using the 
Wilcoxon rank-sum test for continuous variables and the Fisher's exact test for categorical 
vru·iables. 
8.5. 
Efficacy Analysis 
8.5.1. 
Primary Analysis 
The prima1y endpoint for randomized treatment phase is OS as defined in Section 8.1.2. For the 
prima1y efficacy analysis, the difference in OS between the treatment rums will be assessed in 
the ITT Analysis Set using Kaplan-Meier (KM) methods and the stratified log-rank test adjusted 
for the stratification factors. Median, ranges, the prop01iion of subjects who ru·e smviving at 24 
and 48 weeks from randomization (based on KM estimates), hazard ratios and con esponding 
95% Cis (as calculated using a Cox prop01iional hazards regression model) will be presented. 
The following explorat01y sensitivity analyses may be perfonned: 
IT 
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The Cox regression approach will be used to explore the influences of the stratification factors, 
other baseline chru·acteristics, and treatment on OS. 
8.5.2. 
Other Time-to-Event Endpoints 
Differences between the treatment rums in PFS, TTR, and DOR will be assessed in the 
appropriate analysis set using Kaplan-Meier methods and stratified log-rank tests. Medians, 
quruiiles, ranges, hazru·d ratios and conesponding 95% Cis will be presented. 
A supp01iive Cox regression analysis of PFS in the ITT analysis set will be perfonned using the 
Saine methods as in the analysis of OS if a sufficient number of events occm . 
8.5.3. 
Categorical Endpoints 
Difference in ORR and other categorical endpoints between treatment an ns will be compru·ed 
using Cochran-Mantel-Haenszel (CMH) Chi-squru·e tests for association between treatment and 
response, after adjusting for stratification factors. Subjects who do not have sufficient baseline or 
on-study assessment to characterize tumor response will be counted as non-responders. Odds 
ratio and the con esponding 95% Cis will be presented. 
The potential influence of subject baseline characteristics and of treatment on response rates will 
be explored with logistic regression modeling. 
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8.5.4.
Continuous Endpoints
Differences between treatment arms for continuous endpoints will be assessed using analysis of 
covariance (ANCOVA) with stratification factor and treatment as factors and baseline value as 
covariate. In these analyses, both changes from baseline to each subsequent time point and best 
overall on-study changes will be evaluated. Means and standard errors will be presented. 
Least-squares means and 95% CI will be presented.
8.5.5.
Control of Type I Error Rate in Efficacy Analyses
In the efficacy analyses, the following procedures will be implemented to preserve the overall 
type I error rate across the primary and secondary endpoints of the study at a 2-sided significance 
level of 0.05.
The primary endpoint analysis will serve as the gatekeeper for the secondary endpoint analyses, 
ie, the primary efficacy hypothesis must be rejected at the 2-sided 0.05 significance level before 
the efficacy hypotheses for the secondary endpoints will be evaluated.  If the primary hypothesis 
is rejected, the 2 secondary endpoints will be tested sequentially in the order listed (PFS, ORR), 
at the 2-sided 0.05 significance level.  If a null hypothesis is not rejected, formal sequential 
testing will be stopped and only nominal significance will be cited for the remaining secondary 
endpoints.
Analyses and p-values will be reported for all of the efficacy endpoints, including the primary 
endpoints, the secondary endpoints, and all of the exploratory endpoints.
8.6.
Safety Analysis
All safety data collected on or after the date that study drug was first dispensed up to the date of 
last dose of study drug (MMB or placebo) plus 30 days will be summarized by treatment group 
(according to the study drug received). Data for the pretreatment will be included in data listings.
8.6.1.
Extent of Exposure
Descriptive information will be provided by treatment arm regarding the number of doses of 
study drug prescribed, the total number of doses taken, the percent of expected doses taken, the 
number of days of study drug, and the number and timing of prescribed dose modification and 
interruptions.
Compliance will be described by treatment arm in terms of the proportion of study drug actually 
taken based on returned pill count relative to the amount that was dispensed (taking into account 
physician-prescribed modification and interruptions).
8.6.2.
Adverse Events
All AEs will be listed. The focus of AE summarization will be on treatment-emergent AEs. A 
treatment-emergent AE is defined as an AE that occurs or worsens in the period from the first 
dose of IP to 30 days after the last dose of study drug (MMB or placebo).

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AEs will be coded using the Medical Dictionary for Regulatory Activities (MedDRA 
http://www.meddramsso.com) with descriptions by System Organ Class, High-Level Group 
Term, High-Level Term, Preferred Term, and Lower-Level Term. The severity of AEs will be 
graded by the investigator according to the CTCAE, Version 4.03 
(http://evs.nci.nih.gov/ftp1/CTCAE/CTCAE_4.03_2010-0614_QuickReference_8.5x11.pdf), 
whenever possible. If a CTCAE criterion does not exist for a specific type of AE, the grade 
corresponding to the appropriate adjective will be used by the investigator to describe the 
maximum intensity of the AE: Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe), Grade 4 
(life threatening), or Grade 5 (fatal). The relationship of the AE to the IP will be categorized as 
related or unrelated.
Treatment-emergent AEs will be summarized by treatment arm. Summary tables will be
presented to show the number of subjects reporting treatment-emergent AEs by severity grade 
and corresponding percentages. A subject who reports multiple treatment-emergent AEs within 
the same Preferred Term (or System Organ Class) is counted only once for that Preferred Term
(or System Organ Class) using the worst severity grade. AE descriptions will be presented by 
decreasing frequency for a given System Organ Class and Preferred Term. Separate listings and 
summaries will be prepared for the following types of treatment emergent AEs:

Study-drug-related AEs

AEs that are Grade ≥ 3 in severity

AEs leading to IP interruption and/or dose modification

AEs leading to IP discontinuation

SAEs
8.6.3.
Laboratory Evaluations
All laboratory data will be listed. Summaries of laboratory data will be based on observed data.
The focus of laboratory data summarization will be on treatment-emergent laboratory 
abnormalities. A treatment-emergent laboratory abnormality is defined as an abnormality that, 
compared to baseline, worsens by 1 grade in the period from the first dose of study drug 
(MMB or placebo) to 30 days after the last dose of study drug (MMB or placebo). If baseline 
data are missing, then any graded abnormality (ie, an abnormality that is Grade 1 in severity) 
will be considered treatment emergent.
Hematological, serum biochemistry, and urine data will be programmatically graded according 
to CTCAE severity grade, when applicable. For parameters for which a CTCAE scale does not 
exist, reference ranges from the central laboratory will be used to determine programmatically if 
a laboratory parameter is below, within, or above the normal range for the subject’s age, sex, etc.

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Hematological and sennn biochemistiy and their changes from baseline will be summarized by 
u·eatment rum, by visit. Summruy tables will be presented for each relevant assay to show the 
number of subjects by CTCAE severity grade with conesponding percentages. For pru·ameters 
for which a CTCAE scale does not exist, the frequency of subjects with values below, within, 
and above the nonnal ranges will be smnmru·ized. Subjects will be chru·acterized only once for a 
given assay, based on their worst severity grade observed dming a period of interest 
(eg, dming the study or from baseline to a prui iculru· visit). 
Shift tables for hematology and senun biochemistiy will also be presented by showing change in 
CTCAE severity grade from baseline to the worst grade post-baseline. For paraiUeters for which 
a CTCAE scale does not exist, shift tables will be presented showing change in results from 
baseline to the worst grade post baseline. Sepru·ate listings and sUIIllnru·ies will be prepru·ed for 
laborat01y abn01malities that are Grade :2: 3 in severity. 
8.7. 
Pharmacokinetic Analysis 
The concenu·ation data ofMMB and metabolites (GS-644603 and GS-642112), will be 
smnmru·ized by nominal sampling time using descriptive statistics. PK pru·ameters 
(Cmax, Tmax, Clast, T!ast, Ctau, Az, AUCtau, and TY>), if available, will be listed and summru·ized using 
descriptive statistics ( eg, sample size, arithmetic mean, geomeu·ic mean, coefficient of variation 
(%) standru·d deviation, median, minimum, and maximum). Plasma concenu·ations over time will 
be plotted in semi-logru·ithmic and lineru· fonnats as mean± standru·d deviation, and median 
(Q1, Q3) if applicable. 
8.8. 
8.8.1. 
Biomarker Analysis 
Pharmacodynamic Analysis 
The baseline level, and the modulation pattem of tumor tissue pSTAT3 upon u·eatment, 
including change over time from baseline level, will be evaluated. Descriptive statistics will be 
provided at each sampling time, by u·eatment rums. Repeated measmement mixed model 
analysis will be perf01med to assess mean change from baseline over time by u·eatment 
rums. This analysis will be limited to the randomized u·eatment phase substudy subjects 
providing a tumor biopsy tissue saiUple at Week 8. 
8.8.2. 
Exploratory Biomarker Analysis 
PD 
8.9. 
Sample Size 
Based on the historical data (MP ACT u·ial in patients with metastatic pancreatic cancer), the 
median OS was 8.5 months in the nab-P+G group. Ruxolitinib Phase 2 RECAP u·ial (mxolitinib 
or placebo in combination with capecitabine in patients with refract01y metastatic pancreatic 
cancer) reported, in a pre-specified subgroup identified prospectively as most likely to benefit 
from JAK inhibitor u·eatment, the hazru·d ratio (HR) for OS was 0.47. 
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For the randomized treatment phase of the study, a total of 162 OS events need to be observed to 
detect a HR of 0.6 with 90% power at a 2-sided 0.05 significance level. Assuming an accrual rate 
of 20 subjects per months, median OS of 8.5 months in the control arm, and no lost-to-
follow-up, a sample size of 150 subjects in each arm need to be enrolled to observe the 162 OS 
events. The expected study duration of observing 162 OS events in the randomized treatment 
phase is ~21 months.
8.10.
Interim Analysis
One formal interim analysis may be conducted after ~50% of the expected number of OS events 
have been observed. At a constant accrual rate of 20 subjects per month, the interim analysis is 
expected to take place when approximately 230 subjects have been accrued in the study. An 
O’Brien-Fleming boundary will be applied to assess the efficacy at the interim analysis. The 
efficacy boundaries (p-value) for the interim and final analyses will be 0.0031 and 0.049, 
respectively. Boundary-crossing probabilities for the study are provided in Table 8-1.
Table 8-1.
Boundary-Crossing Probabilities at Interim and Final Analyses Based 
on the Assumptions of the Study
Analysis
Expected Events
n (%)
Boundary to 
Reject H0
Boundary-Crossing Probabilities at Each Analysis
Under H0
Under H1
Interim
81 (50%)
0.0031
0.0031
0.2525
Final
162 (100%)
0.0490
0.0469
0.6475
8.11.
Data Monitoring Committee
An external multidisciplinary DMC will review the progress of the study and perform interim 
reviews of safety data on a regular and ongoing basis, and provide recommendation to Gilead 
whether the nature, frequency, and severity of adverse effects associated with study treatment 
warrant the early termination of the study in the best interests of the participants, whether the 
study should continue as planned, or the study should continue with modifications. The 
committee will convene and review the safety data from subjects in the lead-in before the 
initiation of randomized treatment phase, and from subjects in randomized treatment phase at 
approximately 6 months after the first subject is enrolled, and thereafter at intervals of 
approximately 6 months.
The DMC’s specific activities will be defined by a mutually agreed charter, which will define the 
DMC’s membership, conduct and meeting schedule.
While the DMC will be asked to advise Gilead regarding future conduct of the study, including 
possible early study termination, Gilead retains final decision-making authority on all aspects of 
the study.

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9.
RESPONSIBILITIES
9.1.
Investigator Responsibilities
9.1.1.
Good Clinical Practice
The investigator will ensure that this study is conducted in accordance with the principles of the 
Declaration of Helsinki (as amended in Edinburgh, Tokyo, Venice, Hong Kong, and South 
Africa), International Conference on Harmonisation (ICH) guidelines, or with the laws and 
regulations of the country in which the research is conducted, whichever affords the greater 
protection to the study subject. These standards are consistent with the European Union Clinical 
Trials Directive 2001/20/EC and Good Clinical Practice Directive 2005/28/EC.
The investigator will ensure adherence to the basic principles of Good Clinical Practice, as 
outlined in 21 CFR 312, subpart D, “Responsibilities of Sponsors and Investigators,” 21 CFR, 
part 50, 1998, and 21 CFR, part 56, 1998.
The investigator and all applicable subinvestigators will comply with 21 CFR, Part 54, 1998, 
providing documentation of their financial interest or arrangements with GSI, or proprietary 
interests in the investigational drug under study. This documentation must be provided prior to 
the investigator’s (and any subinvestigator’s) participation in the study. The investigator and 
subinvestigator agree to notify GSI of any change in reportable interests during the study and for 
1 year following completion of the study. Study completion is defined as the date when the last 
subject completes the protocol-defined activities.
9.1.2.
Institutional Review Board (IRB)/Independent Ethics Committee (IEC) 
Review and Approval
The investigator (or sponsor as appropriate according to local regulations) will submit this 
protocol, informed consent form, and any accompanying material to be provided to the subject 
(such as advertisements, subject information sheets, or descriptions of the study used to obtain 
informed consent) to an IRB (for studies conducted in the United States) or IEC (for studies 
conducted outside of the United States). The investigator will not begin any study subject 
activities until approval from the IRB or IEC has been documented and provided as a letter to the 
investigator.
Before implementation, the investigator will submit to and receive documented approval from 
the IRB or IEC any modifications made to the protocol or any accompanying material to be 
provided to the subject after initial approval, with the exception of those necessary to reduce 
immediate risk to study subjects.

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9.1.3.
Informed Consent
The investigator is responsible for obtaining written informed consent from each individual 
participating in this study after adequate explanation of the aims, methods, objectives, and
potential hazards of the study and before undertaking any study-related procedures. The 
investigator must use the most current IRB/IEC approved consent form for documenting written 
informed consent. Each informed consent (or assent as applicable) will be appropriately signed 
and dated by the subject or the subject’s legally authorized representative and the person 
conducting the consent discussion, and also by an impartial witness if required by local 
requirements. The consent form will inform subjects about pharmacogenomic testing and 
sample retention, and their right to receive clinically relevant pharmacogenomic analysis results.
9.1.4.
Confidentiality
The investigator must assure that subjects’ anonymity will be strictly maintained and that their 
identities are protected from unauthorized parties. Only subject initials, date of birth, another 
unique identifier (as allowed by local law) and an identification code will be recorded on any 
form or biological sample submitted to the Sponsor or laboratory. Laboratory specimens must be 
labeled in such a way as to protect subject identity while allowing the results to be recorded to 
the proper subject. Refer to specific laboratory instructions.  NOTE: The investigator must keep 
a screening log showing codes, names, and addresses for all subjects screened and for all 
subjects enrolled in the trial. Subject data will be processed in accordance with all applicable 
regulations. 
The investigator agrees that all information received from GSI, including but not limited to the
investigator brochure, this protocol, CRF/eCRF, the IP, and any other study information, remain 
the sole and exclusive property of GSI during the conduct of the study and thereafter. This 
information is not to be disclosed to any third party (except employees or agents directly 
involved in the conduct of the study or as required by law) without prior written consent from 
GSI. The investigator further agrees to take all reasonable precautions to prevent the disclosure 
by any employee or agent of the study site to any third party or otherwise into the public domain.
9.1.5.
Study Files and Retention of Records
The investigator must maintain adequate and accurate records to enable the conduct of the study 
to be fully documented and the study data to be subsequently verified. These documents should 
be classified into at least the following two categories: (1) investigator’s study file, and 
(2) subject clinical source documents.
The investigator’s study file will contain the protocol/amendments, CRF and query forms, and 
governmental approval with correspondence, informed consent, drug records, staff curriculum 
vitae and authorization forms, and other appropriate documents and correspondence.

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The required source data should include sequential notes containing at least the following 
information for each subject:

Subject identification (name, date of birth, gender);

Documentation that subject meets eligibility criteria, eg, history, physical examination, and 
confirmation of diagnosis (to support inclusion and exclusion criteria);

Documentation of the reason(s) a consented subject is not enrolled;

Participation in study (including study number);

Study discussed and date of informed consent;

Dates of all visits;

Documentation that protocol specific procedures were performed;

Results of efficacy parameters, as required by the protocol;

Start and end date (including dose regimen) of IP, including dates of dispensing and return;

Record of all adverse events and other safety parameters (start and end date, and including
causality and severity);

Concomitant medication (including start and end date, dose if relevant; dose changes);

Date of study completion and reason for early discontinuation, if it occurs.
All clinical study documents must be retained by the investigator until at least 2 years or 
according to local laws, whichever is longer, after the last approval of a marketing application in 
an ICH region (eg, United States, Europe, or Japan) and until there are no pending or planned 
marketing applications in an ICH region; or, if no application is filed or if the application is not 
approved for such indication, until 2 years after the investigation is discontinued and regulatory 
authorities have been notified. Investigators may be required to retain documents longer if 
specified by regulatory requirements, by local regulations, or by an agreement with GSI. The 
investigator must notify GSI before destroying any clinical study records.
Should the investigator wish to assign the study records to another party or move them to another 
location, GSI must be notified in advance.
If the investigator cannot provide for this archiving requirement at the study site for any or all of 
the documents, special arrangements must be made between the investigator and GSI to store 
these records securely away from the site so that they can be returned sealed to the investigator 
in case of an inspection. When source documents are required for the continued care of the 
subject, appropriate copies should be made for storage away from the site.

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9.1.6.
Case Report Forms
For each subject consented, an eCRF will be completed by an authorized study staff member 
whose training for this function is documented according to study procedures. eCRF should be 
completed on the day of the subject visit to enable the sponsor to perform central monitoring of 
safety data.  Subsequent to data entry, a study monitor will perform source data verification 
within the EDC system. Original entries as well as any changes to data fields will be stored in 
the audit trail of the system.  Prior to database lock (or any interim time points as described in the 
clinical data management plan), the investigator will use his/her log in credentials to confirm that 
the forms have been reviewed, and that the entries accurately reflect the information in the 
source documents. The eCRF capture the data required per the protocol schedule of events and 
procedures. System-generated or manual queries will be issued to the investigative site staff as 
data discrepancies are identified by the monitor or internal GSI staff, who routinely review the 
data for completeness, correctness, and consistency. The site coordinator is responsible for 
responding to the queries in a timely manner, within the system, either by confirming the data as 
correct or updating the original entry, and providing the reason for the update (e.g. data entry 
error). At the conclusion of the trial, GSI will provide the site with a read-only archive copy of 
the data entered by that site. This archive must be stored in accordance with the records 
retention requirements outlined in Section 9.1.5.
9.1.7.
Investigational Product Accountability and Return
GSI recommends that used and unused IP supplies be returned to the shipping facility from 
which it came for eventual destruction. The study monitor will provide instructions for return. If 
return is not possible, the study monitor will evaluate each study center’s IP disposal procedures 
and provide appropriate instruction for destruction of unused IP supplies. If the site has an 
appropriate standard operating procedure (SOP) for drug destruction as determined by GSI QA, 
the site may destroy used (empty or partially empty) and unused IP supplies in accordance with 
that site’s approved SOP. A copy of the site’s approved SOP will be obtained for central files. 
If IP is destroyed on site, the investigator must maintain accurate records for all IP destroyed. 
Records must show the identification and quantity of each unit destroyed, the method of 
destruction, and the person who disposed of the IP. Upon study completion, copies of the IP
accountability records must be filed at the site. Another copy will be returned to GSI.
The study monitor will review IP supplies and associated records at periodic intervals.
9.1.8.
Inspections
The investigator will make available all source documents and other records for this trial to 
GSI’s appointed study monitors, to IRBs or IECs, or to regulatory authority or health authority 
inspectors.
9.1.9.
Protocol Compliance
The investigator is responsible for ensuring the study is conducted in accordance with the 
procedures and evaluations described in this protocol.

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9.2.
Sponsor Responsibilities
9.2.1.
Protocol Modifications
Protocol modifications, except those intended to reduce immediate risk to study subjects, may be 
made only by GSI. The investigator must submit all protocol modifications to the IRB/IEC in 
accordance with local requirements and receive documented approval before modifications can 
be implemented.
9.2.2.
Study Report and Publications
A clinical study report (CSR) will be prepared and provided to the regulatory agency. GSI will 
ensure that the report meets the standards set out in the ICH Guideline for Structure and Content 
of Clinical Study Reports (ICH E3). Note that an abbreviated report may be prepared in certain 
cases.
Investigators in this study may communicate, orally present, or publish in scientific journals or 
other scholarly media only after the following conditions have been met:

the results of the study in their entirety have been publicly disclosed by or with the consent of 
GSI in an abstract, manuscript, or presentation form or the study has been completed at all 
study sites for at least 2 years

The investigator will submit to GSI any proposed publication or presentation along with the 
respective scientific journal or presentation forum at least 30 days before submission of the 
publication or presentation. 

No such communication, presentation, or publication will include GSI’s confidential 
information (see Section 9.1.4).

The investigator will comply with GSI’s request to delete references to its confidential 
information (other than the study results) in any paper or presentation and agrees to withhold 
publication or presentation for an additional 60 days in order to obtain patent protection if 
deemed necessary.
9.3.
Joint Investigator/Sponsor Responsibilities
9.3.1.
Payment Reporting
Investigators and their study staff may be asked to provide services performed under this 
protocol, e.g. attendance at Investigator's Meetings.  If required under the applicable statutory 
and regulatory requirements, GSI will capture and disclose to Federal and State agencies any 
expenses paid or reimbursed for such services, including any clinical trial payments, meal, travel 
expenses or reimbursements, consulting fees, and any other transfer of value.

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9.3.2.
Access to Information for Monitoring
In accordance with regulations and guidelines, the study monitor must have direct access to the 
investigator’s source documentation in order to verify the accuracy of the data recorded in the 
CRF/eCRF.
The monitor is responsible for routine review of the CRF/eCRF at regular intervals throughout 
the study to verify adherence to the protocol and the completeness, consistency, and accuracy of 
the data being entered on them. The monitor should have access to any subject records needed to 
verify the entries on the CRF/eCRF. The investigator agrees to cooperate with the monitor to 
ensure that any problems detected through any type of monitoring (central, on site) are resolved.
9.3.3.
Access to Information for Auditing or Inspections
Representatives of regulatory authorities or of GSI may conduct inspections or audits of the 
clinical study. If the investigator is notified of an inspection by a regulatory authority the 
investigator agrees to notify the GSI Medical Monitor immediately. The investigator agrees to 
provide to representatives of a regulatory agency or GSI access to records, facilities, and 
personnel for the effective conduct of any inspection or audit.
9.3.4.
Study Discontinuation
Both the sponsor and the investigator reserve the right to terminate the study at any time. Should 
this be necessary, both parties will arrange discontinuation procedures and notify the appropriate 
regulatory authority(ies), IRBs, and IECs. In terminating the study, GSI and the investigator will 
assure that adequate consideration is given to the protection of the subjects’ interests (see 
Section 6.7.2).

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10.
REFERENCES
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Oken MM, Creech RH, Tormey DC, Horton J, Davis TE, McFadden ET, et al. 
Toxicity and response criteria of the Eastern Cooperative Oncology Group. Am J 
Clin Oncol 1982;5 (6):649-55.
17153
Burris HA, 3rd, Moore MJ, Andersen J, Green MR, Rothenberg ML, Modiano 
MR, et al. Improvements in survival and clinical benefit with gemcitabine as first-
line therapy for patients with advanced pancreas cancer: a randomized trial. J Clin
Oncol 1997;15 (6):2403-13.
21890
Conroy T, Desseigne F, Ychou M, Bouche O, Guimbaud R, Becouarn Y, et al. 
FOLFIRINOX versus gemcitabine for metastatic pancreatic cancer. N Engl J Med 
2011;364 (19):1817-25.
24651
Siegel R, Naishadham D, Jemal A. Cancer statistics, 2013. CA Cancer J Clin 
2013;63 (1):11-30.
24788
Wu J, Jester WF, Jr., Orth JM. Short-type PB-cadherin promotes survival of 
gonocytes and activates JAK-STAT signalling. Developmental biology 2005;284 
(2):437-50.
27596
Barbie DA, Tamayo P, Boehm JS, Kim SY, Moody SE, Dunn IF, et al. 
Systematic RNA interference reveals that oncogenic KRAS-driven cancers 
require TBK1. Nature 2009;462 (7269):108-12.
27599
Chan KS, Sano S, Kiguchi K, Anders J, Komazawa N, Takeda J, et al. Disruption 
of Stat3 reveals a critical role in both the initiation and the promotion stages of 
epithelial carcinogenesis. J Clin Invest 2004;114 (5):720-8.
27601
Corcoran RB, Contino G, Deshpande V, Tzatsos A, Conrad C, Benes CH, et al. 
STAT3 plays a critical role in KRAS-induced pancreatic tumorigenesis. Cancer 
Res 2011;71 (14):5020-9.
27602
Downward J. Targeting RAS signalling pathways in cancer therapy. Nature 
reviews. Cancer 2003;3 (1):11-22.
27604
Hedvat M, Huszar D, Herrmann A, Gozgit JM, Schroeder A, Sheehy A, et al. The 
JAK2 inhibitor AZD1480 potently blocks Stat3 signaling and oncogenesis in solid 
tumors. Cancer cell 2009;16 (6):487-97.
27605
Huang C, Cao J, Huang KJ, Zhang F, Jiang T, Zhu L, et al. Inhibition of STAT3 
activity with AG490 decreases the invasion of human pancreatic cancer cells in 
vitro. Cancer science 2006;97 (12):1417-23.

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27612
Toyonaga T, Nakano K, Nagano M, Zhao G, Yamaguchi K, Kuroki S, et al. 
Blockade of constitutively activated Janus kinase/signal transducer and activator 
of transcription-3 pathway inhibits growth of human pancreatic cancer. Cancer 
letters 2003;201 (1):107-16.
27725
Feig C, Gopinathan A, Neesse A, Chan DS, Cook N, Tuveson DA. The pancreas 
cancer microenvironment. Clin Cancer Res 2012;18 (16):4266-76.
27726
Ou YH, Torres M, Ram R, Formstecher E, Roland C, Cheng T, et al. TBK1 
directly engages Akt/PKB survival signaling to support oncogenic transformation. 
Mol Cell 2011;41 (4):458-70.
27727
Scholz A, Heinze S, Detjen KM, Peters M, Welzel M, Hauff P, et al. Activated 
signal transducer and activator of transcription 3 (STAT3) supports the malignant 
phenotype of human pancreatic cancer. Gastroenterology 2003;125 (3):891-905.
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Von Hoff DD, Ramanathan RK, Borad MJ, Laheru DA, Smith LS, Wood TE, et 
al. Gemcitabine Plus nab-Paclitaxel Is an Active Regimen in Patients With 
Advanced Pancreatic Cancer: A Phase I/II Trial. J Clin Oncol 2011;29:4548-54.
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Increased Survival in Pancreatic Cancer with nab-Paclitaxel plus Gemcitabine. N 
Engl J Med 2013;369 (18):1691-703.

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11.
APPENDICES
Appendix 1.
Investigator Signature Page
Appendix 2.
Study Procedures Table
Appendix 3.
Pregnancy Precautions, Definition for Female of Childbearing Potential, and 
Contraceptive Requirements
Appendix 4.
ECOG Performance Status
Appendix 5.
Dose-Escalation Flowchart- Lead-in Phase

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Appendix 1. 
Investigator Signature Page 
GILEAD SCIENCES, INC. 
333 LAKESIDE DR 
FOSTER CITY, CA 94404 
STUDY ACKNOWLEDGEMENT 
A Phase 2, Randomized, Double-blind Study of Gemcitabine and Nab-paclitaxel combined 
with Momelotinib in Subjects with Previously Untreated Metastatic Pancreatic Ductal 
Adenocarcinoma Preceded by a Dose-finding, Lead-in Phase 
GS-US-370-1296, Original, 11 February 2014 
This protocol has been approved by Gilead Sciences, Inc. The following signature documents 
tlrisaf?~ L£t: 
_ P P 0=------
N arne (Pnnted) 
Medical Monitor 
Date 
INVESTIGATOR STATEMENT 
I have read the protocol, including all appendices, and I agree that it contains all necessary 
details for me and my staff to conduct this study as described. I will conduct this study as 
outlined herein and will make a reasonable effort to complete the study within the time 
designated. 
I will provide all study personnel under my supervision copies of the protocol and access to all 
infonnation provided by Gilead Sciences, Inc. I will discuss this material with them to ensure 
that they are fully informed about the drugs and the study. 
Principal Investigator Name (Printed) 
Signature 
Date 
Site Number 
CONFIDENTIAL 
Page 82 
11 February 2014 

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Appendix 2.
Study Procedures Table
Study Phase
Screening
Randomization/
Baseline
Each Cycle 
(28 days +/- 3 
business days)
Every 8 
weeks
Every 12 
weeks
EOT
30-day 
Safety 
Follow-up
5-year Long 
Term Survival 
Follow-up 
Cycle Day
Screening
C1D1
1
8
15
N/A
N/A
N/A
Window (day)
-21
-3
0
±3
±3
N/A
±3
±7
±7
N/A
General and Safety 
Assessments
Informed Consent
X
Medical and Medication 
History 
X
X
X
X
Physical Examination
X
X
X
X
X
Vital Signs1
X
X
X
X
X
X
X
12-lead ECG2
X
X
X
X
X
Adverse events/Concomitant 
medications3
X
X
X
X
X
X
X
IP Accountability and 
Dispensing  
X
X
X
X
X
IXRS Registration
X
X
X
Overall Survival and Other 
Antitumor Therapy
X (Every 6 
months)
1
C1D1 vital signs will be taken pre- and post-MMB/placebo dose every 2 hours for 4 hours; Vital signs will be taken pre-dose only at all subsequent visits
2
Approximately every 2 weeks for first 3 cycles, then on Day 1 of each subsequent cycle. Following completing of a planned thorough QT study and a review of 
cardiovascular-related events, ECG monitoring may be discontinued in this study
3
Adverse events will be assessed at pre- and post-MMB/placebo, nab-P+G dosing during applicable clinic visits. Subjects will also return to clinic at 30-day post last dose 
MMB/placebo or gemcitabine or nab-paclitaxel whichever is later, to assess AEs and SAEs

Momelotnib
Protocol GS-US-370-1296
Final
Gilead Sciences, Inc.
Original
CONFIDENTIAL
Page 84
11 February 2014
Study Phase
Screening
Randomization/
Baseline
Each Cycle (28 
days +/- 3 
business days)
Every 8 
weeks
Every 12 
weeks
EOT
30-day 
Safety 
Follow-up
5-year Long 
Term Survival 
Follow-up 
Cycle Day
Screening
C1D1
1
8
15
N/A
N/A
N/A
Window (day)
-21
-3
0
±3
±3
N/A
±3
±7
±7
N/A
Patient-Reported Outcomes
FACT-Hep
X
X
X
X
EQ-5D
X
X
X
X
Laboratory Assessment
CBC with differential
X
X
X
X
X
X
X
Chemistry
X
X
X
X
X
X
X
Coagulation
X
X
X
X
X
Hepatitis B and C
X
Thiamine status
X
X
Urinalysis and Urine 
Chemistry
X
X
X
X
X
Pregnancy Test4
X
X
X
X
MMB PK5
X
X
X
MMB pharmacodynamic and 
exploratory biomarkers6
X
X
X
4 
If applicable (females of child bearing potential). Serum pregnancy will be conducted at Screening. Urine pregnancy will be conducted pre-dose on Days 1 of each cycle and   
at EOT
5
PK sampling to be performed at the following timepoints: Lead-in phase – Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 12, and 24 hours post-MMB dose on Day 1 and Day 15 of Cycle 1 
(24 hour post-MMB dose sampling is not applicable in twice-daily dosing cohort); Randomized treatment phase – trough samples at approximately 20-26 hours post-MMB 
dose on Day 1 of Cycle 2 and 3 (or at 10-14 hours post-MMB dose in twice-daily dosing cohort) , and pre-dose on Day 1 of Cycles 4, 5, and 6
6
Pharmacodynamic sampling to be performed at the following timepoints: Lead-in phase only – Pre-dose, 1, 2, 4, 12, and 24 hours post-MMB dose on Day 1 and Day 15 of 
Cycle 1 (24 hour post-MMB dose sampling is not applicable in twice-daily dosing cohort); and exploratory biomarkers sampling to be performed at the following timepoints
in both lead-in and randomized treatment phases: Pre-dose at Baseline, Day 1 and Day 15 of each cycle

Momelotnib
Protocol GS-US-370-1296
Final
Gilead Sciences, Inc.
Original
CONFIDENTIAL
Page 85
11 February 2014
Study Phase
Screening
Randomization/
Baseline
Each Cycle (28 
days +/- 3 
business days)
Every 8 
weeks
Every 12 
weeks
EOT
30-day 
Safety 
Follow-up
5-year Long 
Term Survival 
Follow-up 
Cycle Day
Screening
C1D1
1
8
15
N/A
N/A
N/A
Window (day)
-21
-3
0
±3
±3
N/A
±3
±7
±7
N/A
Biopsy tissue sample7
X
Collect archival tumor tissue8
X
Disease Assessments
ECOG Performance Status
X
X
X
X
X
X
X
Treatment Response 
Assessment9
X
X
X
X
CT with contrast or MRI10
X
X
X
7
Biopsy tissue sample to be collected in subset of patients after completion of Cycle 2 at approximately week 8 in both lead-in and randomized treatment phases, and in a 
second subset of patients at disease progression in the randomized treatment phase only. 
8
Unstained slides from archival tumor tissues prepared within 8 weeks of shipment to Gilead or its designee will be collected after Day 1 of Cycle 1 only
9
As per RECIST v1.1
10
Tumor evaluation by CT or MRI will be performed during screening and approximately every 8 weeks regardless of cycle number or dose interruption. Scans may be 
performed at other time points during the treatment phase as clinically indicated. Scans should continue to be done approximately every 8 weeks in subjects who stop 
treatment but did not have disease progression (eg, experienced unexpected toxicity) until progression is documented. The same radiographic procedure to define measurable 
lesion(s) must be used throughout the study for each subject. 

Momelotnib
Protocol GS-US-370-1296
Final
Gilead Sciences, Inc.
Original
CONFIDENTIAL
Page 86
11 February 2014
Appendix 3.
Pregnancy Precautions, Definition for Female of Childbearing 
Potential, and Contraceptive Requirements
1. Pregnancy and Contraception Requirements for Males and Females of Childbearing 
Potential 
The risks of treatment with momelotinib (MMB) during pregnancy have not been evaluated.  
Data available at this time suggest that this drug does not have a drug-drug interaction (DDI) 
with hormones used for contraception.  Please refer to the latest version of the investigator’s 
brochure for additional information.
Please refer to the regional prescribing information for information on the potential risks of 
treatment with gemcitabine and nab-paclitaxel.
2. Definition of Female of Childbearing Potential
For the purposes of this study, a female subject of childbearing potential is a woman who has not 
had a hysterectomy, bilateral oophorectomy, or medically documented ovarian failure. This 
definition includes pubertal females regardless of whether or not she has had a menses 
(premenarchal, Tanner Stage 3) and perimenopausal women who have had a spontaneous 
menses in the last 12 months. A woman who has had a tubal sterilization is considered to be of 
childbearing potential.

Women ≤ 54 years of age with amenorrhea of any duration will be considered to be of 
childbearing potential unless they have had a hysterectomy, bilateral oophorectomy, or 
medically documented ovarian failure.

Women > 54 years of age with cessation (for ≥12 months) of previously occurring menses 
due to ovarian failure will not be considered to be of childbearing potential.
3. Contraceptive Requirements
Male subjects and female subjects of childbearing potential who engage in intercourse must 
agree to utilize protocol specified methods of contraception from the screening/enrollment visit 
throughout the study period and for 30 days following the last dose of study drug MMB. 
Female study subjects who are not heterosexually active must provide periodic confirmation of 
continued abstinence from heterosexual intercourse and regular pregnancy testing while taking 
MMB. The investigator will counsel subjects on the protocol specified method(s) for avoiding 
pregnancy in case the subject chooses to engage in heterosexual intercourse. See 
Appendix Table 1 for the protocol specified contraceptive methods.
Female subjects of childbearing potential must have a negative serum pregnancy test at screening 
and a negative urine pregnancy test at baseline (Day 1) prior to receiving the first dose of study 
drug. Lactating females must discontinue nursing before IP administration.

Momelotnib
Protocol GS-US-370-1296
Final
Gilead Sciences, Inc.
Original
CONFIDENTIAL
Page 87
11 February 2014
Appendix Table 1
Protocol Specified Contraceptive Methods
Methods to Use by 
Themselves
Combination Methods
Hormone Methods
(choose one and use with a barrier 
method)
Barrier Methods
(use both OR choose one and use 
with a hormone method)
Intrauterine Devices (IUDs)

Copper T 380A IUD

LNg 20 IUD
Tubal Sterilization
Estrogen and Progesterone

Oral contraceptives

Transdermal patch

Vaginal ring
Progesterone

Injection

Implant

Diaphragm with spermicide
OR
Cervical cap with spermicide

Male condom (with or without 
spermicide)
Partner’s vasectomy must be used with a hormone or barrier method.
The investigator will counsel all subjects on the most effective method(s) for avoiding pregnancy 
during the study.
4. Additional Requirements for Male Subjects
Male subjects must agree to use condoms during heterosexual intercourse and avoid sperm 
donation while enrolled in the study and for at least 90 days after administration of the last dose 
of IP. 
5. Procedures to be Followed in the Event of Pregnancy
Subjects should be instructed to notify the investigator if they become pregnant at any time 
during the study, or if they become pregnant within 30 days of last study drug dose. Subjects 
who become pregnant or who suspect that they are pregnant during the study must report the 
information to the investigator and discontinue study drug immediately. The investigator should 
report all pregnancies to the CRO Safety Department or Gilead DSPH using the pregnancy report 
form within 24 hours of becoming aware of the pregnancy. The investigator should counsel the 
subject regarding the possible effects of prior study drug exposure on the fetus and the need to 
inform the study site of the outcome of the pregnancy. Subjects whose partner has become 
pregnant or suspects she is pregnant during the study must report the information to the 
investigator. Instructions for reporting pregnancy and pregnancy outcome are outlined in 
Section 7.7.2.1.

Momelotnib
Protocol GS-US-370-1296
Final
Gilead Sciences, Inc.
Original
CONFIDENTIAL
Page 88
11 February 2014
Appendix 4.
ECOG Performance Status
Grade
0
Fully active, able to carry on all pre-disease performance without restriction
1
Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or 
sedentary nature, e.g., light house work, office work
2
Ambulatory and capable of all self care but unable to carry out any work activities.  Up and 
about more than 50% of waking hours
3
Capable of only limited self care, confined to bed or chair more than 50% of waking hours
4
Completely disabled.  Cannot carry on any self care.  Totally confined to bed or chair
5
Dead
Reference for ECOG {9480}

Momelotnib 
Protocol GS-US-370-1296 
Final 
Gilead Sciences, Inc. 
Original 
Appendix 5. 
Dose-Escalation Flowchart- Lead-in Phase 
* Starting dose 
Oosc Level -2 
}..fMB 100 mg(lneednily 
C 
SOO rns'm1 
Nab·P IOO mg m1 
Dos< Lev< I -1 
MMll I 00 mg once dru ly 
0 
1000 n1,y'rn1 
Nab·P JOOmw m' 
Dose L<'••el t• 
MMB 100 mgonccdaily 
G 
JOOO my'm1 
N•b·P 125 mgl m' 
l)oSt l.evc I 2 
MMB 150 n~g once dru ly 
0 
t000 m,g/m1 
Nab·P 125 mg/ m1 
l)osc r .... ,.el 2a 
MM6 1 ~0 mgonccdaily 
0 
JOOO mgt.n1 
Nab·P I 00 mgl no' 
Dose Level 3 
MMB 200 mgonccdaily 
0 
lOOO m.;tm' 
Nllb·P 125 mg/ m' 
CONFIDENTIAL 
Page 89 
11 Febmaty 2014 

Momelotnib 
Protocol GS-US-370-1296 
Gilead Sciences, Inc. 
Dosel.tnl3a 
MMB 200mg Olt<.'C daily 
C 
1000 my m1 
Nab·P 100 m1j m2 
Dosruvd4 
~(9 I SOms twiced3ily 
G 
I 000 n~&ln
2 
Nab·P 1 25m.;;ln•2 
Dose Level 4a 
MMB 150mg ~vice daily 
G 
I 000 mg:m' 
NRb·P IOOm.st m1 
l)osc l,evel 5 
M1\ffi 200 mg twice daily 
G 
1000 mglm' 
Nab-P 12Smg/m2 
Dose Level 5!1 
MMD 200 mg bvict daily 
0 
1000 mg"n' 
Nab-P 100msf m2 
CONFIDENTIAL 
Page 90 
Final 
Original 
11 Febmaty 2014