Clinical trial NCT01999985
Conditions: Lung Cancer Non-small Cell Lung Cancer (NSCLC)
Keywords: Epidermal Growth Factor Receptor (EGFR) Tyrosine kinase inhibitors Neoplasms Lung Diseases Respiratory Tract Diseases Pleural Diseases Pleural Neoplasms Lung Neoplasms Pleural Effusion Pleural Effusion, Malignant Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site EGFR mutation Afatinib Dasatinib Carcinoma, Bronchogenic Gene Mutation T790M mutation. Non-small cell lung cancer
Sponsor: H. Lee Moffitt Cancer Center and Research Institute
Start date: 2013-12-31; Completion date: 2019-05-30
Enrollment: 25 participants; Allocation: NA; Intervention model: SEQUENTIAL

Brief summary:
The purpose of this study is to:

* Find out if the study drugs Afatinib and Dasatinib can be safely given together to patients with lung cancer
* Learn how these two drugs work in cancer cells when they are combined
* Learn more about the side effects of these two drugs when combined
* Find the highest doses of the study drugs Afatinib and Dasatinib that can be given safely without causing serious side effects

Detailed description:

Arms: arm 1: Dose escalation followed by dose expansion. Escalation cohort: Afatinib and Dasatinib. This study is divided into two parts. The first 8 - 18 people will be entered in the first part, called Phase 1A. Then this part will end.

Expansion cohort:: Afatinib and Dasatinib. The next 20 people will enter into the second part, called Phase 1B.
Interventions: intervention 1: Dasatinib - 1A intervention 2: Afatinib - 1A intervention 3: Dasatinib - 1B intervention 4: Afatinib - 1B
Intervention descriptions: intervention 1: 1A: Begins Day 8. Level 1 - 100 mg, Level 2 - 100 mg, Level 3 - 140 mg. intervention 2: 1A: Begins Day 1. Level 1 - 30 mg, Level 2 - 40 mg, Level 3 - 40 mg. intervention 3: In Phase 1B, a mutationally selected 20 participants (total) will be treated at the recommended dose to confirm tolerability and evaluate for early response signal. intervention 4: In Phase 1B, a mutationally selected 20 participants (total) will be treated at the recommended dose to confirm tolerability and evaluate for early response signal.

Protocol documents:
Prot_SAP_000.pdf: 
 
 
 
Phase I Trial Evaluating Safety and Tolerability of the Irreversible Epidermal 
Growth Factor Receptor Inhibitor Afatinib (BIBW 2992) in Combination with the 
SRC Kinase Inhibitor Dasatinib for Patients with Non-small Cell Lung Cancer 
(NSCLC) 
 
NCT01999985 
Version 3.0 
March 22, 2017 


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Phase I Cohort
BIBW2992
 
Begins Day #1 
Dasatinib
 
Begins Day #8 
1.0 
30 mg 
100 mg 
2.0 
40 mg 
100 mg 
3.0 
40 mg 
140 mg 
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Protocol: Phase I Dasatinib/Afatinib in NSCLC 
Version 3.0: March 22, 2017 
 
 
   
 
 
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Summary of Changes – MCC17176 
V2.0 
Section 
Description of Changes 
Rationale 
Title page; Table of Contents 
Updated to version 2.0; added information 
on v1.7 and v1.8 approvals; formatting 
changes; co-investigator list removed; 
CTC removed; page numbers revised 
Updated information applicable to 
amendment. Removed staff lists as they 
are not needed and have changed 
throughout study. Page numbers revised 
according to revisions. 
Protocol Synopsis 
Afatinib lowercase 
Formatting change 
Protocol Synopsis 
Inclusion and Exclusion Criteria deleted 
Inclusion and Exclusion Criteria deleted in 
order to eliminate inconsistency with main 
section.  
Protocol Synopsis 
Deleted “An elective patient decline 
questionnaire will be included after 
screening to guide corrective action.” 
Questionnaire was never developed. 
Study Calendar – Phase IA 
Afatinib uppercase 
Formatting change 
1.1.6  Significance of the Src-TKI 
Dasatinib in NSCLC 
SRC capitalized 
Formatting change 
Table 1: Drugs that may overcome EGFR 
resistance 
Recept deleted 
Formatting change 
4.1 Overview 
Name of IRB deleted 
This information is subject to change and 
was removed.  
5.2 Exclusion Criteria 
Criteria #3 now specifies that only women 
of childbearing potential must have a 
negative pregnancy test.  
Clarify that women who are not of child 
bearing potential should not be subjected 
to a pregnancy test.  
5.2 Exclusion Criteria 
Criteria #17 edited to explain that trace 
pericardial or pleural effusion is acceptable 
among subjects at baseline. 
Clarify that not all pericardial and pleural 
effusion not allowed on study.  
5.2 Exclusion Criteria 
Criteria #19 added azithromycin to the list 
of P-gp inhibitors that are not allowed.  
Modified per guidance on P-gp inhibitors.  
5.2 Exclusion Criteria 
ANC <1000 is exclusion cut off instead of 
1500. 
Revised per letter to IRB that was 
previously approved.  
6.1 Study Calendar 
Pregnancy test for women of child-bearing 
potential. 
Edited to conform with wording used in 
Exclusion criteria. 


6.2.1 Screening Evaluation, 6.3.2 
Definition of DLT; 7.3 Assessment of 
Safety 
NCI-CTCAE spelling  
Typographical error 
6.2.2 Cycle 1 
Dosing for Phase 1B explained. 
Revised for consistency with other 
sections 
6.2.2 Cycle 1 
C1D15 description 
This applies to both Phase 1A and Phase 
1B. Requirement to take study drug in 
clinic removed. 
6.4.1.1 Prohibited Therapies 
Carvedilol and quinidine removed from 
prohibited P-Glycoprotein 
List revised 
6.6 Patient Withdrawl Criteria 
Remove description of subject visit. 
All subjects already assessed for new 
related 21 calendar days; however 30 day 
patient visit is not feasible so removed. 
6.11 Management of Adverse Events 
SPF changed; number of weeks of 
minocycline treatment;   
 
 


Liberty protocol 12.09.006 (MCC 17176) 
 
Cover Letter 
Submission Type: ICF Update 
Liberty IRB, Inc 
1450 S Woodland Blvd  DeLand, FL 32720 
June 9, 2014 
Re: Liberty trial protocol 12.09.0006 
Dear Staff of Liberty Institutional Review Board, 
I am writing to notify your office of an amendment to protocol for Liberty 12.09.0006, (BI 
1200.166, MCC 17176), “Phase I Trial Evaluating Safety and Tolerability of the Irreversible 
Epidermal Growth Factor Receptor Inhibitor Afatinib (BIBW 2992) in Combination with the SRC 
Kinase Inhibitor Dasatinib for Patients with Non-small Cell Lung Cancer (NSCLC)”.  
We have received helpful commentary from the Boehringer-Ingelheim office. On the basis of 
this feedback, we have further refined the clinical trial protocol. Included is the trial protocol 
word document with tracked changes. These changes primarily focused on refining the DLT 
definition and clarifying discrepancies present in the prior version. 
Enclosed in this submission is an updated protocol with tracked changes.  
Also attached is the summary of changes on pages 2 and 3. 
 
 
Thank you for your time and consideration.  
 
Sincerely, 
 
Ben Creelan, MD, MS 
Thoracic Oncology 
12902 Magnolia Dr 
FOB-1, THOR 
1.813.745.3328 
ben.creelan@moffitt.org  
 
 
 


Liberty protocol 12.09.006 (MCC 17176) 
 
Summary of changes: 
1. Changed eligibility so that erlotinib may be continued until up to 3 days of C1D1. The 
mean terminal half-life of erlotinib (OSI-774) is 7 hours in healthy subjects, and closer to 
24 hours at steady-state in cancer subjects. The overall rationale for this amendment is 
to avoid flare phenomenon from erlotinib withdrawal.  
2. Changed dasatinib tablet specification to reflect actual dasatinib tablets received (50 mg 
and 20 mg tablets) 
3. Included the 20 mg afatinib tablet supply received in Product Specifications section 
4. Clarified imaging schedule as first evaluation at day 50, and then every 8 weeks 
thereafter. 
5. Removed mandatory pelvis CT from imaging schedule (this was SOC and does not affect 
budget) 
6. Made screening period tests uniformly within 28 days prior to C1D1. (some areas had 
said 30 days). 
7. Specified purple-top tube for plasma samples On page 10 and page 53 
8.  Inclusion Criteria #5, and Core guidance for Afatinib ALT & AST < 2.5 ULN, not < 3 ULN 
as in exclusion criteria. The exclusion criteria has been amended to < 2.5. 
9. Removed inclusion criteria #5, since it redundant with exclusion criteria #23 
10. Specified that afatinib should be taken 1 hour before/ 2 hours after meals. 
11. Specified a flexibility of +/- 3 days for C1D8 and C1D15. 
12. On page 12 and page 55, Exclusion Criteria # 19, and  Additional pgp inhibitor drugs in 
the BI core protocol have been added to this exclusion criterion, and also page 61, under 
Section 6.4.1.1.  
13. On pages 31, 32 & 33, Section 2.3.1 Table 2 has footnotes have been defined. 
14. On page 50, Section 3.5, add “light” to blue color. 
15. On page 52, Section 4.1, value of 50 days changed to 56 days to align with timeframe in 
study schema. 
16. On page 60, under Section 6.3.2, for clarification: Page 67 of protocol stated “In the 
event of CTCAE Grade > 3 rash, treatment with afatinib and dasatinib should be paused 
until recovery to CTCAE Grade <  1.  Treatment should be resumed at a reduced dose 
per Appendix, “Papulopustular Skin Rash”.”   
Pursuant to this, 6.11.1 section was revised to distinguish between routine CTCAE grade 
3 skin rash, and “severe” skin rash. This definition of severity and management 
algorithm is based upon expert opinion. Lacouture et al, Expert Rev. Anticancer Ther 
13(6) 2013. 
On the basis of above, CTC grade 2 and routine grade 3 skin rash will be managed 
identically, with a separate management plan for “severe grade 3 skin rash”.  Only 
severe grade 3 skin rash will be considered a DLT, as the amendment language now 
states. See tracked changes. 
Along these lines, Section 6.3.2 has been amended to include “severe grade 3 rash 
refractory to optimal supportive care” under DLT definition. 


Liberty protocol 12.09.006 (MCC 17176) 
17. On page 87, under Section 8.1.2, added  “light” to blue color. 
18. Amended Section 9.3 to reflect voluntary reporting to MedWatch under GCP only for 
unexpected drug-related SAEs. Note the reporting responsibilities to Boehringer using BI 
CRF forms remain unchanged. 
19. Removed Section 9.4, 9.5. Based upon feedback from our regulatory specialist, this 
section was redundant and non-applicable, because this particular trial is IND exempt. 
The AE reporting plan and guidelines are already outlined in Section 9.3. 
20. Amended Section 9.1.1: Adverse events section. Based upon feedback from our internal 
monitors, clarified reporting plan for adverse events to specify: “Select events, 
regardless of grade, will be recorded as an AE: diarrhea, skin rash, thrombocytopenia,  
neutropenia, and AST/ALT, bilirubin or creatinine elevation. Other changes in vital signs, 
ECG, physical examination and laboratory test results will not be recorded as an AE in 
the CRF, unless there are clinical signs or symptoms, or they required clinical 
intervention or treatment.” 
21. Amended Section 6.1, 6.2.1: Amended screening procedure window to be consistent 
and uniform 28 days prior to C1D1, instead of 30 days. 
 
 
 
 


Re: MCC 17176 
September 9, 2013 
 
Summary of changes for SRC  
 
Title Page:  updated Principal investigator based upon mutual agreement with Dr Haura and Dr 
Creelan. 
 
Title Page: updated clinical trial coordinator and contact information 
 
Title Page, and onwards: Updated relevant nomenclature throughout protocol, from 
investigational drug name (BIBW 2992) to current generic drug name (afatinib). 
 
Page 44 : updated clinical experience based on most recent investigator’s brochure from Jan 15 
2013, including the FDA approval of afatinib on July 12, 2013. 
 
Page 46:  updated information regarding the clinical trial experience leading to FDA approval of 
afatinib for advanced NSCLC 
 
Page 49:  updated Table 7 to reflect status of ongoing trials 
 
Page 120: Included two new appendices, Appendix 2 and Appendix 3. These independent 
appendices were stipulated to be included in the trial protocol based upon contractual 
agreement with the sponsor, Boehringer‐Ingelheim. 
Sincerely, 
Ben Creelan, MD