Clinical trial NCT02291614
Conditions: GI Adenocarcinoma
Keywords: Amgen Phase 1 Clinical Trial Oncology GI adenocarcinoma Immunotherapy
Sponsor: Amgen
Start date: 2014-11-27; Completion date: 2018-01-09
Enrollment: 45 participants; Allocation: NON_RANDOMIZED; Intervention model: SEQUENTIAL

Brief summary:
The purpose of this Phase 1 study is to determine if AMG 211 given as a continous intravenous (IV) infusion is safe and tolerable in adult participants that have advanced gastrointestinal adenocarcinoma. The study will be conducted in multiple sites and test increasing doses of AMG 211. The safety of participants will be monitored by intensive assessment of vital signs, electrocardiograms, physical examinations, and laboratory tests. Efficacy will be assessed by the usual imaging procedures and their interpretation.

Detailed description:

Arms: arm 1: In cycle 1 participants receive 200 µg/day AMG 211 administered as a continuous intravenous infusion (cIV) infusion at a constant flow rate for 7 days followed by a 3-week treatment-free interval. In cycle 2 and thereafter, participants receive 200 µg/day AMG 211 administered as a cIV infusion for 14 days followed by a 2-week treatment-free interval. arm 2: Participants receive 200 µg/day AMG 211 administered as a cIV infusion for 14 days followed by a 2-week treatment-free interval. arm 3: Participants receive 400 µg/day AMG 211 administered as a cIV infusion for 14 days followed by a 2-week treatment-free interval. arm 4: Participants receive 800 µg/day AMG 211 administered as a cIV infusion for 14 days followed by a 2-week treatment-free interval. arm 5: Participants receive 1600 µg/day AMG 211 administered as a cIV infusion for 14 days followed by a 2-week treatment-free interval. arm 6: Participants receive 1600 µg/day AMG 211 administered as a cIV infusion for 28 days followed by a 2-week treatment-free interval. arm 7: Participants receive 3200 µg/day AMG 211 administered as a cIV infusion for 14 days followed by a 2-week treatment-free interval. arm 8: Participants receive 3200 µg/day AMG 211 administered as a cIV infusion for 28 days followed by a 2-week treatment-free interval. arm 9: Participants receive 6400 µg/day AMG 211 administered as a cIV infusion for 14 days followed by a 2-week treatment-free interval. arm 10: Participants receive 6400 µg/day AMG 211 administered as a cIV infusion for 28 days followed by a 2-week treatment-free interval. arm 11: Participants receive 12,800 µg/day AMG 211 administered as a cIV infusion for 28 days followed by a 2-week treatment-free interval.
Interventions: intervention 1: AMG 211
Intervention descriptions: intervention 1: continuous intravenous infusion (cIV) infusion in cycles from 7 to 28 days

Protocol documents:
Prot_000.pdf: 
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Product:  AMG 211 
Protocol Number:  20130354 
Date:  10 May 2016 
Page 7 of 113 
CONFIDENTIAL 
 
 
Study Design and Treatment Schema* 
Screening (21 days) 
 
 
 
 
6400 µg/d AMG 211 cIV for 28d all cycles 
 
End of Treatment 
 
End of Study (at least 30d after last dose of AMG 211) 
 
 
6400 µg/d AMG 211 cIV for 14d all cycles 
 
 
 
 
 
3200 µg/d AMG 211 cIV for 28d all cycles 
 
 
 
 
 
 
 
 
3200 µg/d AMG 211 cIV for 14d all cycles 
 
 
 
 
1600 µg/d AMG 211 cIV for 28d all cycles 
 
 
 
 
 
 
 
 
1600 µg/d AMG 211 cIV for 14d all cycles 
 
 
 
 
800 µg/d AMG 211 cIV for 28d all cycles 
 
 
 
 
 
 
 
 
 
800 µg/d AMG 211 cIV for 14d all cycles 
 
 
 
 
 
 
 
 
 
 
 
400 µg/d AMG 211 cIV for 14d all cycles 
 
 
 
 
 
 
 
 
 
 
 
200 µg/d AMG 211 cIV for 14d all cycles 
 
Dose Expansion Cohort 
Will begin at the MTD or lower dose 
n = 39 
 
 
 
 
 
 
200 µg/d AMG 211 cIV for 7d cycle 1 
14d cycle 2 and all subsequent cycles 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
AMG 211 7-day & 14-day Schedule 
 7 days cIV dosing followed by 21 days off 
treatment (28-day cycle) cohort 1/cycle 1 only 
 14 days of cIV dosing followed by 14 days off 
treatment (28-day cycle) 
 DLT window is 28 days in all cohorts 
 7 nominal dose levels with potential alternative 
doses 
 The TPI Model may propose a new dose after 
occurrence of the first DLT; decision by DLRT 
 n = 3 to 6 
 
AMG 211 28-day Schedule 
 28 days cIV dosing followed by 14 days off treatment (42-day cycle) 
for cycle 1 
 DLT window is 28 days in all cohorts 
 Expansion to the 28-day schedule will be determined by DLRT 
 The TPI Model may propose a new dose with a 14-day infusion and/or 
a new dose for a 28-day infusion; decision by DLRT 
 Cohorts with 28-day and 14-day schedule can run in parallel or one 
schedule can be prioritized 
 n = 3 to 6 
 
 
 
 
 
 
 
* Depending on the safety data from the 6400 µg/day cohorts, a level of 12800 µg/day can be added, if agreed by the DLRT. The longest schedule allowing highest 
dose intensity (14-day or 28-day infusion) found to be tolerated will be selected for the additional cohort. 
cIV = continuous intravenous; d = day; DLRT = dose level review team; DLT = dose-limiting toxicity; MTD = maximum tolerated dose; TPI = toxicity probability interval 


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SAP_001.pdf: 
20130354
Statistical Analysis Plan, Version 1.0
Dated: 19 May 2014
Page 1 of 34
EFFECTIVE DATE 04-Oct-2010
VERSION NO.V 4.0
STATISTICAL ANALYSIS PLAN 
A Phase 1 Study Evaluating the Safety, Tolerability, Pharmacokinetics, 
Pharmacodynamics, and Efficacy of AMG 211 Administered as Continuous Intravenous 
Infusion in Subjects with Relapsed/Refractory Gastrointestinal Adenocarcinoma
Protocol Number 20130354
Version: Version 1.0
Date:
19 May 2014
Authors: PPD
NCT Number: 02291614
This NCT number has been applied to the document 
for purposes of posting on clinicaltrials.gov


20130354
Statistical Analysis Plan, Version 1.0
Dated: 19 May 2014
                                                                                 Page 2 of 34
                           EFFECTIVE DATE 04-Oct-2010
VERSION NO.V 4.0
TABLE OF CONTENTS
TABLE OF ABBREVIATIONS .........................................................................................4
1.
INTRODUCTION....................................................................................................5
2.
OBJECTIVES.........................................................................................................5
2.1
Primary Objectives......................................................................................5
2.2
Secondary Objectives .................................................................................5
2.3
Exploratory Objectives ................................................................................5
3.
STUDY OVERVIEW ...............................................................................................6
3.1
Study Design...............................................................................................6
3.1.1
Dose Escalation Phase ...............................................................7
3.1.2
Dose Expansion Phase ...............................................................9
3.1.3
Study Schema...........................................................................10
3.2
Sample Size..............................................................................................11
4.
STUDY ENDPOINTS............................................................................................11
4.1
Primary Endpoints.....................................................................................11
4.2
Secondary Endpoints................................................................................11
4.3
Exploratory Endpoints...............................................................................11
5.
HYPOTHESES AND/OR ESTIMATION................................................................12
6.
DEFINITIONS.......................................................................................................12
7.
ANALYSIS SUBSETS ..........................................................................................18
7.1
Safety Analysis Set ...................................................................................18
7.2
Pharmacokinetic Concentration Analysis Set ............................................18
7.3
Dose Escalation Analysis Set....................................................................18
8.
INTERIM ANALYSIS AND EARLY STOPPING GUIDELINES..............................18
9.
DATA SCREENING AND ACCEPTANCE ............................................................19
9.1
General Principles.....................................................................................20
9.2
Data Handling and Electronic Transfer of Data .........................................20
9.3
Handling of Missing and Incomplete Data .................................................20
9.4
Detection of Bias.......................................................................................20
9.5
Outliers .....................................................................................................20
9.6
Distributional Characteristics.....................................................................20
9.7
Validation of Statistical Analyses...............................................................20
10.
STATISTICAL METHODS OF ANALYSIS............................................................21
10.1
General Principles.....................................................................................21
10.2
Subject Accountability...............................................................................21
10.3
Important Protocol Deviations ...................................................................21


20130354
Statistical Analysis Plan, Version 1.0
Dated: 19 May 2014
                                                                                 Page 3 of 34
                           EFFECTIVE DATE 04-Oct-2010
VERSION NO.V 4.0
10.4
Demographic and Baseline Characteristics...............................................22
10.5
Safety Analyses ........................................................................................22
10.5.1
Adverse Events .........................................................................22
10.5.2
Laboratory Test Results ............................................................23
10.5.3
Vital Signs .................................................................................24
10.5.4
Electrocardiogram (ECG) ..........................................................25
10.5.5
Karnofsky Performance Status..................................................26
10.5.6
Physical Measurements ............................................................26
10.5.7
Antibody Formation ...................................................................26
10.5.8
Exposure to Investigational Product ..........................................26
10.5.9
Exposure to Concomitant Medication ........................................26
10.6
Efficacy Analyses......................................................................................26
10.6.1
Disease Response Analyses.....................................................26
10.6.2
Best Overall Response..............................................................27
10.6.3
Time to Progression ..................................................................27
10.6.4
Progression Free Survival .........................................................27
10.6.5
Tumor Burden ...........................................................................27
10.6.6
Tumor Biopsy............................................................................28
10.6.7
Duration of Response................................................................28
10.6.8
Time to Response .....................................................................28
10.7
Analyses of Exploratory Endpoints............................................................28
10.8
Pharmacokinetic or Pharmacokinetic/Pharmacodynamic Endpoints .........28
10.9
Changes from Protocol-Specified Analyses ..............................................29
11.
LIST OF PLANNED TABLES, FIGURES AND LISTINGS [TFLs] .........................29
12.
LITERATURE CITATIONS REFERENCES ........................................................29
13.
PRIORITIZATION OF ANALYSES .......................................................................29
14.
DATA NOT COVERED BY THIS PLAN................................................................29
15.
APPENDICES ......................................................................................................30
Appendix A.  Technical Detail and Supplemental Information Regarding Statistical 
Procedures and Programs......................................................................30
Appendix B.  Code Fragments.......................................................................................31
Appendix C.  Toxicity Probability Interval (TPI) Bayesian Design ..................................32
Appendix D.  DLRM Outputs List...................................................................................34


20130354
Statistical Analysis Plan, Version 1.0
Dated: 19 May 2014
                                                                                 Page 4 of 34
                           EFFECTIVE DATE 04-Oct-2010
VERSION NO.V 4.0
TABLE OF ABBREVIATIONS
Abbreviation/Acronym
Definition
AE
Adverse event
BQL
Lower limit of quantifications
CI
Confidence interval
cIV
Continuous intravenous
CL
Systemic clearance
Css
Steady-state drug concentration in plasma 
during constant-rate infusion
CSR
Clinical study report
CT 
Computed tomography 
CTCAE 
Common terminology criteria for adverse 
events 
DLT 
Dose limiting toxicity 
DMP
Data management plan
ECG
Electrocardiogram
ECOG 
Eastern Cooperative Oncology Group 
EOS
End of study
irCR
Immune-related Complete Response
irPD
Immune-related Progressive Disease
irRC
Immune-related Response Criteria  
irSD
Immune-related Stable Disease
PK
Pharmacokinetic(s)
PKDM
Pharmacokinetics and drug metabolism
MRI 
Magnetic resonance imaging 
MTD 
Maximum tolerated dose 
PD 
Progressive disease 
PR 
Partial response 
RECIST 
Response evaluation criteria in solid 
tumors 
SAE 
Serious adverse event 
SAP
Statistical analysis plan
SLD
Sum of longest diameters


20130354
Statistical Analysis Plan, Version 1.0
Dated: 19 May 2014
                                                                                 Page 5 of 34
                           EFFECTIVE DATE 04-Oct-2010
VERSION NO.V 4.0
1.
INTRODUCTION 
The purpose of this statistical analysis plan (SAP) is to provide details of the statistical analyses 
that have been outlined within the protocol for AMG 211 Study 20130354 dated 24 March 2014.  
The scope of this plan includes the interim analysis and the final analysis that are planned and 
will be executed by the Biostatistics department or designee unless otherwise specified eg, 
standard PK tables may be provided by PKDM.
2.
OBJECTIVES 
2.1
Primary Objectives

Evaluate the safety and tolerability of AMG 211 in adult subjects with relapsed/refractory GI 
adenocarcinomas

Determine the maximum tolerated dose (MTD) and/or biologically active dose (eg, 
recommended phase 2 dose)
2.2
Secondary Objectives

Describe the pharmacokinetics (PK) of AMG 211

Determine the formation of anti-AMG 211 antibodies

Evaluate time to progression and to evaluate the proportion of subjects progression-free at 6 
months

Evaluate the anti-tumor activity of AMG 211 by evaluating
−
The number and proportion of subjects with objective response according to the modified
Immune-related Response Criteria (irRC)
−
The duration of response and time to response
2.3
Exploratory Objectives

Evaluate the protein, nucleic acid, and cellular biomarkers in blood (eg, cytokines, 
lymphocyte subsets) before and following treatment with AMG 211

Evaluate the effects of genetic variations in cancer genes and multiple other aspects of the
tumor and tumor microenvironment before and following treatment with AMG 211 which may
include CEA expression, markers of necrosis or apoptosis, and potential changes in the
nature and number of tumor infiltrating lymphocytes


20130354
Statistical Analysis Plan, Version 1.0
Dated: 19 May 2014
                                                                                 Page 6 of 34
                           EFFECTIVE DATE 04-Oct-2010
VERSION NO.V 4.0
3.
STUDY OVERVIEW
3.1
Study Design
This is a multi-center, open-label, sequential dose-escalation study evaluating AMG 211 as a 
cIV infusion in adult subjects who have relapsed/refractory GI adenocarcinoma. Table 1
presents an overview of the study design. Additional details follow below.
Table 1. Study Design Overview
Part
Cohort
Dose Level
Number of 
Subjects
Dose 
Escalation
1
200 µg/d for 7 days in cycle 1
200 µg/d for 14 days in cycle 2 and all 
subsequent cycles
3-6
2
200 µg/d for 14 days in all cycles
3-6
3
400 µg/d for 14 days in all cycles
3-6
4
800 µg/d for 14 days in all cycles
3-6
5
1600 µg/d for 14 days in all cycles
3-6
6
3200 µg/d for 14 days in all cycles
3-6
7
6400 µg/d for 14 days in all cycles
3-6
28-day 
Schedule
X-1
Dose Level -1 of 14-day Schedule × 28 days
3-6
X-2
MTD × 28 days
3-6
Dose Expansion
A
MTD or Highest Tested Dose
10
Abbreviations: d = day; DLT = dose-limiting toxicity; DRLM = dose level review meeting; EC50 = 50% of 
the maximal effective concentration level; MTD = maximum tolerated dose; PD = pharmacodynamic; PK = 
pharmacokinetic.
a Alternative dosing regimens (eg, 28-day infusions) may be explored after a DLRM decision based on
1) occurrence of DLT(s) or other emerging safety data; 2) PK/PD data demonstrating drug exposure that 
is in the range or above the mean EC50 concentration of 29 ng/mL; 3) absence of objective responses in 
the 14-day infusion schedule.
In the dose-escalation cohorts, subjects will be assigned sequentially into cohorts as they open. 
Three subjects will initially be enrolled into each dose-escalation cohort with at least a 48-hour 
interval between treatment of subject 1 and subject 2 of each cohort. In the event that a DLT is 
observed, additional subjects may be enrolled for a total of up to 6 evaluable subjects.


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VERSION NO.V 4.0
The dose-expansion cohort will be initiated after completion of the dose-escalation cohorts. Up 
to 10 subjects will be enrolled and treated at the dose level determined in the dose-escalation 
cohorts.
Subjects will be treated with AMG 211 until confirmed disease progression per modified irRC 
(Appendix D in the protocol), or intolerance of study treatment, or clinically significant 
deterioration of health status requiring discontinuation, whichever occurs first. Due to the 
mechanism of action of immune-enhancing therapies, subjects may experience an apparent
enlargement of existing lesions or the appearance of new lesions prior to maximal clinical 
benefit of AMG 211.
For the schedule of assessment, please refer to section 7.1 in the protocol.
3.1.1
Dose Escalation Phase
The dose-escalation part of the study is aimed at determining the MTD, safety, tolerability, PK, 
and PD of AMG 211. Planned dose levels for the dose-escalation cohorts are as follows: 200, 
400, 800, 1600, 3200, and 6400 μg/d. Alternative dose levels may be explored based on 
emerging data.
Subjects in cohort 1 of the dose-escalation cohorts will receive AMG 211 for 7 days followed by 
21 days off treatment (cycle 1). After completing cycle 1, if no DLTs are observed, all subjects in 
cohort 1 will be allowed to continue treatment with the same dose of AMG 211, but the infusion 
duration will be 14 days followed by 14 days off treatment.
In the subsequent dose-escalation cohorts, AMG 211 will be administered at escalating doses in 
a 2 weeks on and 2 weeks off schedule. Based on the results, the Dose Level Review Team 
(DLRT) may choose to extend the infusion duration from 14 to 28 days (a 4 weeks on and 2 
weeks off schedule) if the 14-day administration schedule has been well tolerated and the safety 
profile allows for a longer infusion duration, and no anti-tumor response has been observed in 
the 14-day administration schedule.
Moreover, the DLRT may decide to enroll in parallel into a cohort with a 28-day treatment 
duration or to prioritize one infusion schedule.
Dose escalation decisions will consider the incidence of DLTs among DLT-evaluable subjects
that occur during the first 28 days of treatment. For definition of DLT-evaluable subjects, please 
refer to section 3.4 in the protocol.
A safety review of dose escalation is planned after all subjects in dose escalation have had the 
opportunity to complete 6 months of the treatment.


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3.1.1.1
Dose Escalation and Dose Stopping Rules
Escalation to a higher dose cohort will only proceed when the previous dose(s) has (have) been
found to be reasonably tolerated based on available study data through the DLT period for all 
DLT-evaluable subjects enrolled within a cohort and upon unanimous decision of the DLRM 
members. Dosing changes will be made on a treatment cohort basis and a case-by-case basis. 
Dose schedule changes will be made on a case-by-case basis. Dose decisions are planned 
after every 3 to 6 DLT-evaluable subjects are enrolled throughout the dose-escalation cohorts. 
Decisions made during the meeting will be documented in a dose level review memo. 
The DLRT considers the recommendation for subsequent doses based on the following rules:

Based on the modified TPI Bayesian model, the next dose is the one with the highest 
probability of the target TPI (0.20, 0.35), but with a less than 0.25 probability of an excessive 
or unacceptable TPI.

If ≥ 1 subject has a DLT at a dose level, then dose escalation cannot occur unless there are 
6 or more DLT-evaluable subjects at that dose level. However, if a transient cytokine-release 
syndrome is reported as the DLT, but resolves within 48 hours and can be managed with 
prophylactic corticosteroids, the DLRT may decide to escalate the dose with the institution of 
prophylactic corticosteroid administration.

The maximum allowed dose increase will be 1 dose level above the maximum of previous 
evaluated doses.

Dose escalation can be achieved by evaluating a higher dose level with the same infusion 
duration (eg, 800 μg/day for 14 days to 1600 μg/day for 14 days), or by evaluating the same 
dose level with a prolonged infusion duration (eg, from 800 μg/day for 14 days to 800 μg/day 
for 28 days). The DLRT may also decide to explore in parallel both options mentioned above 
after the dose-escalation decision is made, or to prioritize one schedule. In this case, 2 TPI 
models may be run in parallel to obtain dose recommendations for these 2 schedules 
separately.

Intermediate dose levels not pre-specified may be considered based on the optimal dose 
recommended by the TPI model.
The DLRT is responsible for making the decision to end dose escalation. The DLRT may 
consider the modeling of dose escalation complete if 1 of the following rules is met:

The highest planned dose level is evaluated and no DLTs occur at any dose level. In this 
case the maximum administered dose will be used in a dose-expansion cohort.

The TPI Bayesian model recommends the same dose 3 times (not necessarily sequentially).


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
A total of approximately 24 DLT-evaluable subjects have been enrolled.
3.1.2
Dose Expansion Phase 
At the completion of the dose-escalation cohorts, additional subjects (up to 10) will be enrolled 
into a dose-expansion cohort to gain further clinical experience with AMG 211.
The dose to be evaluated will be at or below the MTD from the dose-escalation cohorts.
A final estimate of the recommended phase 2 dose will be based on the toxicity probability 
interval (TPI) Bayesian model using all DLT-evaluable subjects.
See Section 3 of the protocol for further details.


Product:  AMG 211
Protocol Number:  20130354
Date:  19 May 2014                                                                                                  Page 10 of 34
3.1.3
Study Schema
Screening (14 days)
6,400 µg/d AMG 211 cIV for 28d all cycles
End of Treatment
End of Study (at least 30d after last dose of AMG 211)
6,400 µg/d AMG 211 cIV for 14d all cycles
3,200 µg/d AMG 211 cIV for 28d all cycles
3,200 µg/d AMG 211 cIV for 14d all cycles
1,600 µg/d AMG 211 cIV for 28d all cycles
1,600 µg/d AMG 211 cIV for 14d all cycles
800 µg/d AMG 211 cIV for 28d all cycles
800 µg/d AMG 211 cIV for 14d all cycles
400 µg/d AMG 211 cIV for 14d all cycles
200 µg/d AMG 211 cIV for 14d all cycles
Dose Expansion
Will begin at the MTD or lower dose
n=10
200 µg/d AMG 211 cIV for 7d cycle 1
14d cycle 2 and all subsequent cycles
AMG 211 7-day & 14-day Schedule
7 days cIV dosing followed by 21 days off 
treatment (28-day cycle) cohort 1/cycle 1 only
14 days of cIV dosing followed by 14 days off 
treatment (28-day cycle)
DLT window is 28 days in all cohorts
7 nominal dose levels with potential additional
doses
The TPI Model may propose a new dose after 
occurrence of the first DLT; decision by DLRT
n=3 to 6
AMG 211 28-day Schedule
28 days cIV dosing followed by 14 days off treatment (42-day cycle) 
for cycle 1
DLT window is 28 days in all cohorts
Expansion to the 28-day schedule will be determined by DLRT
The TPI Model may propose a new dose with a 14-day infusion and/or 
a new dose for a 28-day infusion; decision by DLRT
Cohorts with 28-day and 14-day schedule can run in parallel or one 
schedule can be prioritized
n=3 to 6
cIV = continuous intravenous; d = day; DLRT = dose level review team; DLT = dose-limiting toxicity; MTD = maximum tolerated dose; TPI = toxicity probability interval


Product:  AMG 211
Protocol Number:  20130354
Date:  19 May 2014                                                                                                  Page 11 of 34
3.2
Sample Size 
It is anticipated that up to 34 subjects will be enrolled in this study. Approximately 24 subjects 
will be enrolled in the dose-escalation cohorts and up to 10 subjects will be enrolled in the dose-
expansion cohort.
The sample size in dose-escalation cohort is determined empirically and is consistent with this 
type of study using a modified TPI Bayesian model design (Bailey et al, 2009; Neuenschwander 
et al, 2008).
Refer to Appendix E in the protocol for details of the modified TPI Bayesian model, the average 
sample size, and other design operating characteristics.
In the dose-escalation cohorts, with 3 DLT-evaluable subjects per dose level, there is a 49% to 
73% probability of observing at least 1 DLT if the true DLT rate is 20% to 35%.
In the dose-expansion cohort, an exact 80% binomial confidence interval (CI) will be provided 
for the ORR. With 10 subjects and 20% ORR, the expected 80% CI and its half-width would be 
5.4% to 45.0% and 19.8%, respectively. In this case, the probability of observing at least 1 ORR 
among 10 subjects is 89.2% and the probability of observing at least 2 ORRs is 62.4%.
4. STUDY ENDPOINTS 
4.1
Primary Endpoints

Safety: subject incidence of adverse events, DLTs, and clinically significant changes in vital 
signs, ECGs, physical examination findings, and clinical laboratory tests
4.2
Secondary Endpoints

PK of AMG 211 after cIV infusion across 2 cycles

Incidence of anti-AMG 211 antibody formation

Time to progression

6-month progression-free rate

Efficacy parameters: overall response rate (ORR; per modified irRC), duration of response, 
time to response
4.3
Exploratory Endpoints

Changes in methylation and mutations in circulating free DNA present in plasma

Lymphocyte counts, T-cell activation and immune checkpoint regulator status


Product:  AMG 211
Protocol Number:  20130354
Date:  19 May 2014                                                                                                  Page 12 of 34

Changes in serum cytokine levels

Biomarkers and mutations in tumor cells

Changes in CTCs

sCEA serum levels
5. HYPOTHESES AND/OR ESTIMATION
The hypothesis for this phase 1 study is that objective responses according to modified irRC will 
be observed at dose levels that achieve acceptable safety and tolerability.
6. DEFINITIONS
Adverse Event (AE) 
An adverse event is defined as any untoward medical occurrence in a clinical trial subject. The 
event does not necessarily have a causal relationship with study treatment. The definition of 
adverse events includes worsening of a preexisting medical condition. Worsening indicates that 
the preexisting medical condition (eg, diabetes, migraine headaches, gout) has increased in 
severity, frequency, and/or duration, and/or has an association with a significantly worse 
outcome. A preexisting condition that has not worsened during the study, or involves an 
intervention such as elective cosmetic surgery or a medical procedure while on study, is not 
considered an adverse event.
Age at Enrollment
Subject age at enrollment will be determined using the age in years reported in the clinical 
database.
AUCinf
Area under the concentration-time curve from time zero to infinity.
Baseline
Unless otherwise specified, the baseline value for parameters/assessments scheduled to be 
performed on the same day as the first administration of AMG 211, is the last value measured 
before the first administration of AMG 211 on that day. For parameters/assessments not 
scheduled to be performed (or scheduled but not performed) on the same day as the first 
administration of AMG 211, the baseline value is the value from the screening period measured 


Product:  AMG 211
Protocol Number:  20130354
Date:  19 May 2014                                                                                                  Page 13 of 34
closest to the day of first administration of AMG 211. In the event that multiple assessments are 
done on the same day as the first administration of AMG 211 and there is no time associated 
with the assessments, the value associated with the last clinically planned event before the first 
administration of AMG 211 will be used as the baseline value. 
Best Overall Response
Best overall response for a subject is the best observed post baseline disease response per 
modified Immune-Related Response Criteria (irRC). Any irCR or irPR must be confirmed by 
consecutive repeat assessments performed at least 4 weeks after the criteria for response are 
first met. The confirmatory scan can also be performed at the next scheduled imaging visit. An 
irPD must be confirmed by consecutive repeat assessments performed at least 4 weeks apart in 
the absence of rapid clinical deterioration. The confirmation scan may also be performed at the 
next imaging assessment as defined by the schedule of assessment after the first observation if 
the subject has stable or improved clinical status. Subjects with a global deterioration of health 
status requiring discontinuation of treatment without objective evidence of disease progression 
at the time should have the reason for treatment discontinuation classified as non-confirmed 
disease progression. The investigator reported response information collected on the CRF 
and/or Independent review committee assessments will be used to determine the response.  
Change From Baseline
Change from Baseline is the arithmetic difference between post-Baseline and Baseline.
Css
Steady-state drug concentration in serum calculated as average concentration between 
achievement of plateau and EOI during constant-rate infusion. 
Complete Response
Complete response is defined using the modified irRC as outlined in Appendix D of the protocol.  
Dose Limiting Toxicity (DLT) 
Please refer to section 6.2.1.3 in the protocol for definition of DLT. 


Product:  AMG 211
Protocol Number:  20130354
Date:  19 May 2014                                                                                                  Page 14 of 34
Duration of Response
Duration of response is defined as the number of days between the date of the first tumor 
assessment indicating an objective response through to the subsequent date of progression as
classified by modified irRC or death due to any cause, or where applicable date of censoring
[date of first progressive disease assessment or death or date of censoring – date of the first 
objective response result +1].  Subjects who respond and have not progressed while on study or 
died for reasons other than disease progression will be censored at the date of assessment of 
the last evaluable radiological assessment. Subjects who do not achieve an objective response 
will be excluded from the analysis of duration of response. 
End of Investigational Product Administration 
End of IP Administration for each subject is defined as the date the decision was made to end IP 
as recorded on the End of IP CRF page.
End-of-Study
The end of study date for an individual subject is recorded on the end of study CRF page. End 
of study (EOS) for an individual subject is defined as the date of the final study visit (EOS visit) 
when safety assessments and procedures are performed. The EOS visit should occur 
approximately 4 weeks (+ 1 week) after the last dose of AMG 211 or at the initiation of other 
therapy. Subjects who complete the EOS visit will be considered to have completed the study.
Primary Completion: the time when the last subject is assessed or receives an intervention for 
the purposes of final collection of data for the primary analysis; the primary analysis for this 
study will occur after all dose-escalation cohort subjects and dose-expansion cohort subjects 
have completed 6 months of treatment or have discontinued treatment with AMG 211.
End of Trial: the time when the last subject is assessed or receives an intervention for evaluation 
in the study; the final analysis will occur at this time.
Enrollment 
A subject is considered enrolled on day 1 (cycle 1 day 1) when the cIV infusion with 
investigational product is first administered. See protocol section 5.0 for further details.
Fridericia-corrected QT Interval (QTcF)


Product:  AMG 211
Protocol Number:  20130354
Date:  19 May 2014                                                                                                  Page 15 of 34
The Fridericia correction will be calculated from the investigator reported QT (msec) and RR 
interval (msec), as follows: 
QTcF=QT/(RR/1000)1/3
Investigational Product
The term ‘investigational product’ is used in reference to AMG 211.
Last Investigational Product Dose Date 
The last IP dose date for each subject is defined as the latest date IP is administered.
Maximum Tolerated Dose (MTD)
Given the toxicity probability interval (TPI) specified, after each cohort, the model’s 
recommended MTD dose for evaluation is the dose with the highest probability of the target TPI, 
but with a less than 0.25 probability of an excessive or unacceptable TPI. The actual dose 
selected at each dose decision may be at or below the model’s recommended dose as 
determined at a DLRM by the dose level review team (DLRT) after considering all information. 
A final model estimate of the MTD will be obtained utilizing all the dose-escalation cohort and 
dose-expansion cohort DLT-evaluable subjects.
Percent Change From Baseline
Percent change from Baseline is the arithmetic difference between post-Baseline and Baseline 
divided by Baseline values times 100.
Progression-Free Survival Time
Progression-free survival time is calculated as the number of days from the first administration of 
AMG 211 to the first assessment of disease progression as per modified irRC or clinical 
progression, whichever occurs first or death due to any cause, or if applicable date of censoring 
(date of progressive disease or death or censoring – date of study day 1 +1). Progression-free 
Survival Time will incorporate the independent radiologic review and/or the Investigator-reported 
assessment. The progression-free rate at 6 months is defined as the proportion of subjects with 
no disease or clinical progression at 6 months from the first administration of AMG 211. 


Product:  AMG 211
Protocol Number:  20130354
Date:  19 May 2014                                                                                                  Page 16 of 34
The following censoring strategies for missing assessment dates will be used for the 
progression free survival analysis:
If a subject’s disease has not progressed and the subject is alive, progression-free survival time 
will be censored at the last date they are known to be progression-free (ie, the last evaluable 
radiological assessment date).
If a subject has no tumor evaluation in the study, progression-free survival time will be censored 
at the date of the first administration of AMG 211.
Subjects who withdraw consent to participate in the study prior to disease progression will be 
censored at their last evaluable radiological assessment date.
Screened
A subject is considered in screening once a consent form has been signed.
Study Day
Post study day 1:
study day= (date - date of Study Day 1) + 1
Pre study day 1:       study day= (date – date of Study Day 1)
Study Day 1
Study day 1 is defined as the first day of administration of the investigational product after 
enrollment.  The day prior to Study Day 1 is considered Day -1.  
Treatment-Emergent Adverse Event (TEAE)
A treatment-emergent adverse event is any adverse event starting on or after the first dose of 
investigational product, as determined by the flag indicating if the adverse event started prior to 
the first dose on the Adverse Events Summary CRF, and up to and including 30 days after the 
end of investigational product.


Product:  AMG 211
Protocol Number:  20130354
Date:  19 May 2014                                                                                                  Page 17 of 34
Treatment-Related AE
A treatment-related AE is any treatment-emergent AE that per investigator review has a 
reasonable possibility of being caused by the investigational product.
Time to Progression (TTP)
Time to progression is calculated as the number of days from the first administration of AMG
211 to the first objective assessment of disease progression as per modified irRC or if applicable 
date of censoring (date of progressive disease or censoring – date of study day 1 +1). Time to 
progression will incorporate the independent radiologic review and/or the Investigator-reported 
assessment.
The following censoring strategies for missing assessment dates will be used for the time to 
progression analysis:
If a subject’s disease has not progressed and the subject is alive, time to progression will be 
censored at the last date they are known to be progression-free (ie, the last evaluable 
radiological assessment date).
If a subject has died, time to progression will be censored at the date of death.
If a subject has no tumor evaluation in the study, progression-free survival time will be censored 
at the date of the first administration of AMG 211.
Subjects who withdraw consent to participate in the study prior to disease progression will be 
censored at their last evaluable radiological assessment date.
Time to Response
Time to response is calculated as the number of days from the first administration of AMG 211
to the first objective assessment of response as per modified irRC or if applicable date of
censoring (date of first response or censoring – date of study day 1 +1). 
The following censoring strategies for missing assessment dates will be used for the time to 
response analysis:
If a subject did not respond, time to response will be censored at the latest evaluable 
radiological assessment date.
If a subject has no tumor evaluation in the study, time of response will be censored at the date 
of the first administration of AMG 211.
Tumor Burden


Product:  AMG 211
Protocol Number:  20130354
Date:  19 May 2014                                                                                                  Page 18 of 34
Tumor burden is derived as the sum of the products of the 2 longest perpendicular diameters 
(SPD) of all index lesions (5 lesions per organ and up to 10 total lesions) and new measurable 
lesions (≥5 × 5 mm; up to 5 new lesions per organ and 10 total lesions) if any, per irRC
guidelines.

Tumor burden = SPDindex lesions + SPDnew, measurable lesions
7. ANALYSIS SUBSETS
The analysis of all endpoints, unless noted otherwise, will be conducted on the Safety Analysis 
Set defined in Section 7.1.
7.1
Safety Analysis Set
The Safety Analysis Set will consist of all subjects that are enrolled and receive at least 1 dose 
of AMG 211. For the dose escalation part of the study subjects analyzed according to the initial 
AMG 211 dose received. For the dose expansion, subjects will be analyzed according to the 
dose selected for this part of the study.
7.2
Pharmacokinetic Concentration Analysis Set
The pharmacokinetic (PK) concentration analysis set will contain all subjects who received 
investigational product and have at least one PK sample collected.
7.3
Dose Escalation Analysis Set
The analysis of DLT will be restricted to DLT-evaluable subjects.  The DLT window is 28 days 
for all cohorts and is independent of the length of the infusion.  A subject is not DLT-evaluable if 
he/she drops out before completion of cycle 1 (defined as completed 90% of the planned dose 
in cycle 1) for reasons other than an adverse event related to the investigational product.  This 
analysis Set will consist of all available data from all DLT-evaluable subjects, with subjects 
analyzed according to the treatment received initially as described for the Safety Analysis Set.
Ineligible subjects may be replaced.   
8. INTERIM ANALYSIS AND EARLY STOPPING GUIDELINES


Product:  AMG 211
Protocol Number:  20130354
Date:  19 May 2014                                                                                                  Page 19 of 34
Dose decision analyses are planned after every 3 to 6 DLT-evaluable subjects are enrolled 
throughout the dose-escalation cohorts.  The DLRT considers the recommendation for 
subsequent doses based on the following rules:

Based on the modified TPI Bayesian model (Bailey et al, 2009; Neienschwander et al, 2008), 
the next dose is the one with the highest probability of the target TPI (0.20, 0.35), but with a 
less than 0.25 probability of an excessive or unacceptable TPI.

If ≥ 1 subject has a DLT at a dose level, then dose escalation cannot occur unless there are 
6 or more DLT-evaluable subjects at that dose level.  However, if a transient cytokine-
release syndrome is reported as the DLT, but resolves within 48 hours and can be managed 
with prophylactic corticosteroids, the DLRT may decide to escalate the dose with the 
institution of prophylactic corticosteroid administration.

The maximum allowed dose increase will be 1 dose level above the maximum of previous 
evaluated doses.  

Dose escalation can be achieved by evaluating a higher dose level with the same infusion 
duration (eg, 800 µg/day for 14 days to 1600 µg/day for 14 days), or by evaluating the same 
dose level with a prolonged infusion duration (eg, from 800 µg/day for 14 days to 800 µg/day 
for 28 days).  The DLRT may also decide to explore in parallel both options mentioned 
above after the dose-escalation decision is made, or to prioritize one schedule.  In this case, 
2 TPI models may be run in parallel to obtain dose recommendations for these 2 schedules 
separately.  

Intermediate dose levels not pre-specified may be considered based on the optimal dose 
recommended by the TPI model.  
The DLRT is responsible for making the decision to end dose escalation.  Generally, the DLRT 
may consider the modeling of the dose escalation complete if 1 of the following rules is met:

The highest planned dose level is evaluated and no DLTs occur at any dose level.  In this 
case the maximum administered dose will be used in a dose-expansion cohort.

The TPI Bayesian model recommends the same dose 3 times (not necessarily sequentially).

A total of approximately 24 DLT-evaluable subjects have been enrolled.
The Amgen Medical Monitor and Amgen Global Safety Officer can make dose decisions without 
convening the DRLT in the following limited circumstances:

If a cohort has at least 3 DLT-evaluable subjects and 1 subject experiences a DLT, then the 
Amgen Medical Monitor and Amgen Global Safety Officer may decide to expand the number 
of subjects treated in this cohort.

The Amgen Medical Monitor and Amgen Global Safety Officer may decide to open the next 
cohort using a de-escalated dose (de-escalated from the dose level of the most recent 
cohort), if this de-escalated dose had been previously evaluated by the DLRT.
A safety review of dose escalation is planned after all subjects in dose escalation have had the 
opportunity to complete 6 months of the treatment.
9. DATA SCREENING AND ACCEPTANCE


Product:  AMG 211
Protocol Number:  20130354
Date:  19 May 2014                                                                                                  Page 20 of 34
9.1
General Principles
The objective of the data screening is to assess the quantity, quality and statistical 
characteristics of the data relative to the requirements of the planned analyses.
9.2
Data Handling and Electronic Transfer of Data 
Amgen’s Clinical Data Management department will provide all data to be used in the planned 
analyses.   The database will be subject to edit checks outlined in the Clinical Data Management 
Plan (DMP). See details of this section in the DMP.
9.3
Handling of Missing and Incomplete Data
The following imputation for missing or incomplete data will be performed if required:
Incomplete adverse event and concomitant medication dates missing data will be imputed as 
described in Appendix A.
Non-pharmacokinetic measurements (eg. biomarker data) that are below the lower limit of 
quantification will be considered equal to half of the lower limit of quantification for all analyses 
unless specified otherwise.  
Please refer to section 10.8 for details of handling missing or incomplete PK concentration data.
9.4
Detection of Bias 
Lack of protocol compliance and the potential for biased statistical analyses will be examined by 
assessing the incidence of important protocol deviations in each cohort.  The clinical study team 
will identify and document the criteria for important protocol deviations. 
9.5
Outliers
Outlier data will not be excluded unless scientifically justified.
PK plasma concentration data will be evaluated for outliers by visual inspection and decisions to 
re-assay individual samples will be made in accordance with standard PKDM practices.
9.6
Distributional Characteristics
Where appropriate, the assumptions underlying the proposed statistical methodologies will be 
assessed. If required data transformations or alternative non-parametric methods of analyses 
will be utilized.  
9.7
Validation of Statistical Analyses


Product:  AMG 211
Protocol Number:  20130354
Date:  19 May 2014                                                                                                  Page 21 of 34
Programs will be developed and maintained, and output will be verified in accordance with 
current risk-based quality control procedures. Tables, figures and listings will be produced with 
validated standard macro programs where standard macros can produce the specified outputs.  
The production environment for statistical analyses consists of Amgen-supported versions of 
statistical analysis software, for example the SAS System and S-plus. 
10. STATISTICAL METHODS OF ANALYSIS
10.1
General Principles
Descriptive statistics will be provided for selected demographic, safety, PK, PD, and biomarker 
data by dose schedule and time as appropriate.  Descriptive statistics on continuous data will 
include means, medians, SDs, and ranges, while categorical data will be summarized using 
frequency counts and percentages.  Graphical summaries of the data may also be presented.  
When data are summarized by time, the values recorded against the scheduled time points 
listed in the protocol will be used.  When assessing minimum/maximum increases or decreases 
over the study, all assessments, including unscheduled assessments will be used.  In general, 
data listings will be sorted by dose, subject, and time.
The primary analysis is planned after all dose-escalation cohorts and dose-expansion subjects 
have had the opportunity to complete 6 months of treatment.
A final analysis is planned after all dose-escalation cohorts and dose-expansion subjects have 
ended the study.
10.2
Subject Accountability
The number and percent of subjects who were screened, enrolled, received investigational 
product, completed investigational product, discontinued from investigational product (including 
reasons for discontinuing),completed study, discontinued the study (including reasons for 
discontinuing) will be summarized by dose schedule and time.  
Key study dates for the first subject enrolled, last subject enrolled, last subject’s end of study will 
be presented.
A subject listing and summary noting inclusion in each analysis subset will be provided for all 
subjects enrolled.  A subject listing noting duration of AMG 211 administration, reason for 
discontinuation of treatment, and reason for discontinuing the study will be provided.  A list of 
subjects screened but not enrolled (screen failures) will be provided.
10.3
Important Protocol Deviations
Important Protocol Deviations (IPDs) categories are defined by the study team before the first 


Product:  AMG 211
Protocol Number:  20130354
Date:  19 May 2014                                                                                                  Page 22 of 34
patient visit and updated during the IPD reviews throughout the study prior to database lock.  If a 
snapshot is being taken during the study rather than a database lock at the end of the study, 
categories should be updated during the IPD reviews throughout the study prior to database 
lock.  These definitions of IPD categories, sub-category codes and descriptions will be used 
during the course of the study.  The final IPD list is used to produce the Summary of IPDs table 
and the List of Subjects with IPDs. In addition, a separate listing of all inclusion and exclusion 
deviations will be provided.
10.4
Demographic and Baseline Characteristics
Demographic (ie, age, age groups [< 65, >= 65 and >= 75], sex, race, ethnicity, and baseline 
characteristics (height, weight, and Karnofsky performance status) will be summarized by dosing 
schedule and overall using descriptive statistics. If multiple races have been reported for a 
subject, the subject will be categorized as multiple races as well as by the combination of races.
A listing of the demographic and baseline characteristics will be provided. In addition listings of 
medical history (including antecedent hematologic or oncologic disease, other 
diseases/symptoms such as fatigue, bleeding, and infection whether resolved and ongoing), 
surgical history, prior anti-cancer usage and prior radiotherapy usage will be provided.
10.5
Safety Analyses
10.5.1
Adverse Events
The Medical Dictionary for Regulatory Activities (MedDRA) version 16.0 or later will be used to 
code all adverse events to a system organ class and a preferred term.  The subject incidence of 
adverse events will be summarized for all treatment-emergent, serious treatment emergent, 
treatment-related, serious treatment-related, those leading to withdrawal of investigational
product or other protocol-required therapies, fatal adverse events, and significant treatment 
emergent adverse events.  The identification of significant adverse events is a continuous 
process.  Events may be identified and documented as the safety profile of the drug is 
characterized. The severity of each adverse event will be graded using CTCAE version 4.03
criteria. 
Subject incidence of all treatment-emergent, serious, treatment-related, serious 
treatment-related, those leading to withdrawal of investigational product or other protocol-
required therapies, significant treatment-emergent adverse events, and fatal adverse events will 
be tabulated by system organ class and preferred term in descending order of frequency. Where 
appropriate the tables will also be presented by worst grade. The above adverse event tables 
will not be created if two or fewer subjects experience the adverse event. 


Product:  AMG 211
Protocol Number:  20130354
Date:  19 May 2014                                                                                                  Page 23 of 34
Details of each adverse event will be listed.  Listings and/or narratives of any on-study deaths, 
serious and significant treatment-emergent adverse events, including early withdrawals due to 
adverse events, also will be provided should they occur.
10.5.1.1
Dose Limiting Toxicities
The analysis of the probability of dose limiting toxicities (DLT) will be based on the Dose 
Escalation Analysis Set defined in Section 7.3. A listing and summary of the subject incidence of 
dose limiting toxicities (DLT) will be provided should they occur.
The planned primary nominal doses are 200, 400, 800, 1600, 3200 and 6400 µg/d. Potential 
intermediate doses with a 2- fold increment and a 50% reduction from the starting dose will be 
considered after DLT is observed. The dose-escalation cohorts will use a TPI Bayesian design
to guide dose escalation.  The MTD target TPI for DLT is (0.20, 0.35), and TPIs of (0.35, 0.60) 
and (0.60, 1.00) are defined as excessive and unacceptable, respectively.  The design seeks to 
identify a dose most likely to have a DLT rate in the target TPI, but with overdose control that 
limits the possibility that the dose has an excessive or unacceptable DLT rate (Babb et al, 1998).  
The probability of a DLT at dose level di is assumed to follow a Bernoulli distribution with 
probability pi where the logit of pi increases linearly with the log of the standardized dose in the 
following 2-parameter logistic model:
log [pi / (1-pi)] = logit(pi) = log[a] + exp(log[b]) log (di / dmax)
where a and b are random variables and dmax is the maximum planned dose.  
The probability of each TPI and of a DLT will be summarized by dose along with the estimated 
dose-toxicity curve. A final estimate of the MTD will be estimated from the TPI Bayesian model 
utilizing all DLT-evaluable subjects. Please refer to Appendix C for more details on the TPI 
model and its operation characteristics.
10.5.2
Laboratory Test Results
10.5.2.1
Chemistry, Hematology and Coagulation
Individual chemistry, hematology and coagulation laboratory data will be listed and select 
parameters of interest plotted.  Values outside the normal laboratory reference ranges will be 
flagged as high or low on the listings.  CTCAE grades will also be highlighted where appropriate.
Unscheduled assessments will be incorporated in the laboratory analyses where possible. 
The number and percentage of subjects experiencing treatment emergent laboratory toxicities
with worst post dose CTCAE grades of ≥1, ≥2, ≥3 and 4 will be presented.   The direction of the 
laboratory worsening will be denoted. The summary will be presented for all laboratory 


Product:  AMG 211
Protocol Number:  20130354
Date:  19 May 2014                                                                                                  Page 24 of 34
parameters for which at least one subject experienced a treatment emergent toxicity with a 
worst grade ≥3. 
Additionally, the number and percentage of subjects experiencing 1, 2, 3 and 4 worsening
CTCAE grade shifts from baseline will be presented.  The direction of the laboratory worsening 
will again be denoted.  
Shifts tables indicating the change between the baseline and the maximum post dose CTCAE 
grades for an increased value, and the maximum post dose grade for a decreased value will be 
provided for selected laboratory parameters of interest.
A listing of CTCAE grade 3 or higher laboratory toxicities will be provided.  This listing will 
include all laboratory data for the subject and laboratory parameter of interest in order to provide 
proper context.  A flag will indicate the grade 3 or higher toxicity.
Summaries of the absolute value and/or changes from baseline at each scheduled assessment 
will be provided for selected laboratory parameters of interest.
A summary of the change from baseline to the post dose maximum, time to post-dose 
maximum, change from baseline to the post dose minimum, and the time to the post dose 
minimum may also be provided for selected parameters of interest.     
Potential Hy’s law cases will be listed and may also be summarized.
10.5.2.2
Urinalysis
Individual urinalysis data will be listed and select parameters of interest plotted.
Blood, protein, glucose and ketones will be graded in the following manner: 0=’0 or Trace’, 
1=’1+’, 2=’2+’, 3=’3+’, 4=’4+’. Microscopic parameters (WBC, epithelial cells, bacteria, casts, 
crystals) will be graded in the following manner: 0=’0-4 none, rare, occasional’, 1=’5-50 
moderate, few’, 2=’>50 many, heavy, too numerous to count’.
The number and percent of subjects with a worst post-dose presence of blood in the urine of ‘0 
or Trace’, ‘1+’,’3+’, or ‘4+’ will be presented (also for protein, glucose, and ketones in the urine).
Summaries of the absolute value and/or changes from baseline at each scheduled assessment 
will also be provided.
10.5.3
Vital Signs


Product:  AMG 211
Protocol Number:  20130354
Date:  19 May 2014                                                                                                  Page 25 of 34
Vital signs will be listed for each subject.   The analysis of vital signs will include summary 
statistics at selected time points for each subject.  Shifts in vital sign values from baseline over 
time will be tabulated for each subject.
10.5.4
Electrocardiogram (ECG)
All on-study electrocardiogram (ECG) data will be listed and select parameters of interest may 
be plotted.
Summaries over time and/or changes from baseline over time will be provided for all 12-lead 
ECG parameters.  
The analysis of Fridericia’s (QTcF) QT correction will use the results recorded on the CRF.
Subjects’ maximum change from baseline in QT interval corrected by Fridericia’s formula will be 
categorized into the following groups per their maximum change from baseline in QTcF.
Unscheduled assessments will be included in the determination of the maximum change.

<=30 msec

>30 – 60 msec

>60 msec
The number and percentage of subjects in each group will be summarized.
Subjects will also be categorized into the following groups per their maximum post baseline 
QTcF. Unscheduled assessments will be included in the determination of the maximum post 
baseline value.

<=450 msec

>450 – 480 msec

>480 – 500 msec

>500 msec
The number of subjects in each group will be summarized for each dosing group. 
In addition, the relationship between plasma concentration of AMG 211 and change from 
baseline in QTcF will be explored graphically.


Product:  AMG 211
Protocol Number:  20130354
Date:  19 May 2014                                                                                                  Page 26 of 34
10.5.5
Karnofsky Performance Status
Karnofsky performance status scores will be summarized at each assessed time point. The 
change in scores from baseline to each assessed time point and from baseline to safety follow-
up will also be summarized.
10.5.6
Physical Measurements 
The change in weight from baseline to each scheduled assessment time point will be 
summarized.   
10.5.7
Antibody Formation 
Positive anti-AMG 211 anti-body data will be listed and reviewed for each subject. Summaries of 
positive anti-AMG 211 anti-body test results over time may be provided. 
10.5.8
Exposure to Investigational Product
Descriptive statistics will be produced to describe the exposure to investigational product by 
dosing schedule. The number of cycles, number of doses of investigational product and the total
dose in µg will be summarized. 
Details for each AMG 211 administration will be listed for every subject.  In addition a listing of 
the unique manufacturing lot numbers, and a listing of the subjects administered each 
manufacturing lot number will be provided.   
10.5.9
Exposure to Concomitant Medication 
All medication will be coded using the WHO drug dictionary.  A subject listing of all prior and 
concomitant medications will be presented.
10.6
Efficacy Analyses 
Statistical analyses of efficacy endpoints will be considered exploratory. Efficacy data will be 
conducted on the Safety Analysis Set. Dose/exposure-response relationship may be explored 
graphically.
10.6.1
Disease Response Analyses
All disease response data will be reported descriptively in the form of listings for all subjects. 
Listings will be produced for all subjects in the dose-escalation cohorts and the dose-expansion 
cohorts indicating the time to progression, objective response, time to response, and duration of 
response.  
Unscheduled tumor assessments will be included in the response classifications for any analysis 
incorporating disease response data.


Product:  AMG 211
Protocol Number:  20130354
Date:  19 May 2014                                                                                                  Page 27 of 34
10.6.2
Best Overall Response
The number and percentage of subjects with a best overall disease/tumor response of complete 
response (irCR), partial response (irPR), stable disease (irSD) or progressive disease (irPD) will 
be presented for the dose escalation and/or expansion parts of the study. Subjects with best 
overall response of irSD should meet a minimum duration of 8 weeks at the time of scan. 
In addition, the proportion of subjects treated at MTD with an overall response (ORR) and 
corresponding exact 80% confidence interval calculated using the Clopper-Pearson method
(Clopper and Pearson, 1934) will be tabulated. Unevaluable subjects treated at MTD will be 
treated as non-responders and included in the calculation of ORR.
10.6.3
Time to Progression
Kaplan Meier curve will be presented for time to tumor progression with estimates for rates and 
80% CI at selected weeks. Subjects treated at MTD will be included for this analysis.
10.6.4
Progression Free Survival
The proportion of subjects that are progression free at 6 months with corresponding exact 80% 
CI will be calculated using the Clopper-Pearson method. Subjects treated at MTD will be 
included for this analysis.
Kaplan Meier curve will also be presented as a sensitivity analysis with estimates for rates and 
80% CI if subjects come off study prior to 6 months for reasons besides disease progression.   
10.6.5
Tumor Burden
At each on-study radiological assessment, tumor burden will be derived as the sum of the 
products of the longest perpendicular diameters of the all index and new measurable lesions will 
be recorded. Baseline tumor burden will be the sum of the products of the 2 longest 
perpendicular diameters (SPD) of all the index lesions. The percentage change from baseline in 
tumor burden and percentage change from nadir will be recorded on the eCRF: 
Individual subject time profiles of the percentage change from baseline will be generated for 
each part of the study.  The initial dose group and primary tumor type will be highlighted.
For the dose escalation, the maximum percentage improvement (maximum decrease or 
minimum increase over the whole study) in the tumor burden will be plotted for each subject
(waterfall plot). The initial dose group, primary tumor type and best overall response will be 
highlighted.  This analysis will be repeated for subjects in the dose expansion part of the study.


Product:  AMG 211
Protocol Number:  20130354
Date:  19 May 2014                                                                                                  Page 28 of 34
In addition, summary statistics on percentage change from baseline by time point will be 
generated for subject treated at MTD.
10.6.6
Tumor Biopsy
Tumor biopsy data will be listed.
10.6.7
Duration of Response
Duration of response will be analyzed using the Kaplan-Meier method.  Kaplan-Meier curves 
and median duration along with 80% CI will be presented.  Subjects without an objective 
response are excluded from the analyses of this endpoint.
10.6.8
Time to Response
Time to response will be analyzed using the Kaplan-Meier method.  Kaplan-Meier survival 
curves and median time along with 80% CI will be presented.
10.7
Analyses of Exploratory Endpoints 
Graphical summaries of changes from baseline over time in biomarker levels may be provided.  
Association between baseline levels or presence of tumor biomarkers will be explored 
graphically for objective response and PD effects. If evident, correlation analyses for changes in 
biomarkers and tumor response or progression free survival will be performed.
10.8
Pharmacokinetic or Pharmacokinetic/Pharmacodynamic Endpoints
AMG 211 serum concentration-time data will be used to determine the PK parameters using 
non-compartmental methods and will be listed for individual subjects. The following parameter 
will be estimated:  Css, calculated as average concentration between achievement of plateau 
and EOI.  Only in cycle 1 the following parameters will be estimated: t1/2 and AUCinf.  Other 
parameters such as CL and Vss may be estimated. Post dose serum concentrations below the 
lower limit of quantifications (BLQ) will be set to missing for non-compartmental analysis or 1/2 
BQL for potential population PK analysis while those at predose will be set to zero.  Actual 
dosing and sampling time will be used for PK analysis.  The reasons for excluding any sample 
from the analyses will be provided. Other types of analysis such as compartmental modeling 
and population PK may be performed if necessary dependent on the data. The result of 
additional analysis may be reported separately from the clinical study report (CSR).
Individual concentration-time data will be tabulated and presented graphically.  Mean 
concentration-time profiles for each dose will be provided using scheduled time.  PK parameters 
will be summarized for each dose level using descriptive statistics, including subject numbers, 
means, standard deviations, medians, minimums, and maximums.


Product:  AMG 211
Protocol Number:  20130354
Date:  19 May 2014                                                                                                  Page 29 of 34
For dose proportionality analyses, Css will be dose normalized and log transformed prior to 
analysis. A linear regression may be performed using ln(Css) as the dependent variable and 
ln(dose) as the independent variable. The scatter plots will show these estimated curves as well 
as the 90% confidence region around these curves. Tables will be generated to show the 
parameter estimates as well as the 90% confidence interval for the slope of the model. Given 
the broad dose range included in this study, the dose proportionality analyses may be restricted 
to the dose range being considered for the next stage of development.
PK/PD modeling may be performed if data are adequate to explore the relationship between 
AMG 211 exposure and various PD endpoints.
10.9
Changes from Protocol-Specified Analyses
There are no changes to the protocol-specified analyses. 
11. LIST OF PLANNED TABLES, FIGURES AND LISTINGS [TFLs]
The definitive list of TFLs to be produced for this study is documented in the Programme Index.
12. LITERATURE CITATIONS REFERENCES
Babb, J, Rogatko A, Zacks S.  Cancer phase I clinical trials: efficient dose escalation with 
overdose control.  Stat Med 1998;17:1103-1120.
Bailey S, Neuenschwander B, Laird G, Branson M. A Bayesian case study in oncology
phase I combination dose-finding using logistic regression with covariates. J Biopharm
Stat. 2009;19:469-484.
Clopper CJ, Person ES. The use of confidence or fiducial limits illustrated in the case of the 
binomial.  Biometrika.  1934;26:404-413.
Neuenschwander B, Branson M, Gosponer T. Critical aspects of the Bayesian approach to 
phase I cancer trials. Stat Med. 2008;27:2420-2439.
13. PRIORITIZATION OF ANALYSES 
There is no prioritization of analyses.
14. DATA NOT COVERED BY THIS PLAN 
Exploratory data not included in this plan may be analyzed at a later date or may be analyzed by 
a different Amgen Department.


Product:  AMG 211
Protocol Number:  20130354
Date:  19 May 2014                                                                                                  Page 30 of 34
15. APPENDICES 
Appendix A.  Technical Detail and Supplemental Information Regarding Statistical 
Procedures and Programs
Imputation Rules for Partial or Missing Stop Dates
If the month and year are present, impute the last day of the month.  If only the year is present, 
impute December 31 of that year.  If the stop date is entirely missing, assume the event or 
medication is ongoing.  If a partial or complete stop date is present and the ‘ongoing’ or 
‘continuing’ box is checked, then it will be assumed that the AE or conmed stopped and the stop 
date will be imputed, if partial.
Imputation Rules for Partial or Missing Start Dates
Stop Date
Complete: 
yyyymmdd
Partial: yyyymm
Partial: yyyy
Missing
Start Date
<1st
Dose
1st
Dose
<1st Dose 
yyyymm
1st Dose 
yyyymm
<1st
Dose 
yyyy
1st
Dose 
yyyy
Partial: 
yyyymm
=1st Dose 
yyyymm
2
1
2
1
N/A
1
1
1st Dose 
yyyymm
2
2
2
2
2
Partial: 
yyyy
=1st Dose 
yyyy
3
1
3
1
N/A
1
1
1st Dose 
yyyy
3
3
3
3
3
Missing
4
1
4
1
4
1
1
1 = Impute the date of first dose
2 = Impute the first of the month
3 = Impute January 1 of the year
4 = Impute January 1 of the stop year
Note: For subjects who were never treated (first dose date is missing), partial start dates will be 
set to the first day of the partial month.
Note: If the start date imputation leads to a start date that is after the stop date, then do not 
impute the start date.


Product:  AMG 211
Protocol Number:  20130354
Date:  19 May 2014                                                                                                  Page 31 of 34
CCI


Product:  AMG 211
Protocol Number:  20130354
Date:  19 May 2014                                                                                                  Page 32 of 34
Appendix C.  Toxicity Probability Interval (TPI) Bayesian Design
The dose-escalation cohorts will use a TPI Bayesian design to guide dose escalation.  The MTD 
target TPI for DLT is (0.20, 0.35), and TPIs of (0.35, 0.60) and (0.60, 1.00) are defined as 
excessive and unacceptable, respectively.  The design seeks to identify a dose most likely to 
have a DLT rate in the target TPI, but with overdose control that limits the possibility that the 
dose has an excessive or unacceptable DLT rate (Babb et al, 1998).  The probability of a DLT at 
dose level di is assumed to follow a Bernoulli distribution with probability pi where the logit of pi
increases linearly with the log of the standardized dose in the following 2-parameter logistic 
model:
log [pi / (1-pi)] = logit(pi) = log[a] + exp(log[b]) log (di / dmax)
where a and b are random variables and dmax is the maximum planned dose.  
A minimally informative prior distribution (Neuenschwander et al, 2008) was selected for theta = 
(log a, log b) where the probability that the true DLT rate is ≤ 0.60 at the lowest dose (200 
µg/day for 7 days) is 0.90 and the probability the true DLT rate is ≤ 0.20 at the maximum dose 
(6400 µg/day for 14 days) is 0.21.  Median values for pi were interpolated per the logistic model.  
For each di, 2 quantiles for pi were selected from a Beta distribution with the target median and a 
precision < 2.  This set of quantiles fully specified a target prior for theta.  A bivariate normal 
distribution for theta was assumed where (log a) has a normal distribution with mean ma and 
standard deviation sa, and (log b) has a normal distribution with mean mb and standard 
deviation sb, and r is the correlation between (log a) and (log b).  Numerical integration was 
used to calculate Pr[pi ≤ q(di)], where q(di) is a quantile for dose di.  An optimal bivariate normal 
distribution was estimated that achieved the minimum sum of squared difference between 
achieved and specified quantiles across all doses.  The bivariate normal distribution prior 
solution has ma = 0.0536, sa = 1.685, mb = -0.1469, sb = 1.001, and r = -0.216.
The operating characteristics of the TPI Bayesian design were evaluated via simulation.  The 
cohort size was fixed to be 3 subjects.  All simulated studies started with an initial dose of 200 
µg/day for 7 days and subsequent doses were selected based on the rules specified in 
Section 8.
The design was evaluated for two possible dose-response scenarios consistent with the 
design’s model:  “Low” and “High” MTDs.  The target MTD of these 2 scenarios are set to be 
1/3, and this target was set at a dose of 400 µg/day for 14 days, and 3200 µg/day for 14 days for 
the Low High scenarios, respectively.  An “acceptable” final dose was defined as one with the 


Product:  AMG 211
Protocol Number:  20130354
Date:  19 May 2014                                                                                                  Page 33 of 34
highest or second highest target TPI probability and a less than 0.25 excessive or unacceptable 
TPI probability.  The acceptable doses by scenario were 200, 400 for Low and 1600, 3200 for 
High.  The bivariate normal distribution for each scenario was estimated as per the prior.  A 
Bernoulli probability for each subject in the simulations was selected from a random sample for 
the bivariate normal distribution for a given scenario, and a random DLT outcome for the subject 
was generated based on this DLT probability.  
The simulation results are summarized in the table below.  The average sample size increased 
from 15.7 to 20.8 in Low to High MTD scenarios.  Early DLTs resulted in close to 5% chance of 
stopping with no dose selection in both cases due to the over-dose control criteria.  The average 
Low and High final dose was about 360 and 1600 µg/d.  The rate of acceptable dose selection is 
higher in Low scenario (83.1%), comparing with High scenario (51.4%).  The average number of 
DLTs and DLT rate is higher in Low scenario than High scenario due to early occurrence of 
DLTs.
Simulation Results of TPI Model
Low
Acceptable Dose: 200, 400
High
Acceptable Dose: 1600, 3200
Number of Subjects (IQR)
15.7 (15, 18)
20.8 (18, 24)
Acceptable Rate (95% CI)
83.1% (80.6%, 85.4%)
51.4% (48.3%, 54.5%)
No Dose Rate (95% CI)
4.5% (3.3%, 6.0%)
3.7% (2.6%, 5.1%)
Dose (IQR)
358.0 (200, 400)
1583.8 (800, 1600)
Number of DLTs (IQR)
3.8 (2, 4)
3.1 (2, 4)
DLT Rate
24.1%
15.0%
      CI = confidence interval; DLT = dose-limiting toxicity; IQR = interquartile range


Product:  AMG 211
Protocol Number:  20130354
Date:  19 May 2014                                                                                                  Page 34 of 34
Appendix D.  DLRM Outputs List
Listings:
1. subject demographics 
2. date, time, dose of investigational product administration
3. electrocardiogram (ECG) results, change from baseline
4. vital signs 
5. reported adverse events (AEs)
6. safety laboratory data (chemistry, hematology, Urinalysis, coagulation )
7. medical history 
8. concomitant medications
9. prior chemotherapy data
Figures
1. line plot of vital signs by time course
2. line plot of all safety labs by time course
3. line plot of ECGs results by time course 
4. DLT probability plot at each dose [TPI design if DLT is observed]