A Comparison Between BMS-690514 and Erlotinib in Patients Who Were Previously Treated for NSCLC
A Double-Blind, Randomized, Parallel Two-Arm Phase II Trial of BMS-690514 Versus Erlotinib in Previously Treated NSCLC Patients
2 other identifiers
interventional
141
8 countries
30
Brief Summary
The purpose of this study is to improve disease control and survival for patients who were treated with chemotherapy using BMS-690514 over erlotinib
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Mar 2009
Typical duration for phase_2
30 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 27, 2008
CompletedFirst Posted
Study publicly available on registry
August 29, 2008
CompletedStudy Start
First participant enrolled
March 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2012
CompletedOctober 12, 2015
September 1, 2015
1.4 years
August 27, 2008
September 23, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
To compare the progression-free survival of patients on BMS-690514 with those on erlotinib
CT/MRI at baseline and every 6 weeks for 36 weeks
Secondary Outcomes (6)
To compare the overall survival between BMS-690514 and erlotinib
15 months
To estimate the overall response rate of BMS-690514 or erlotinib
15 months
To estimate the tumor size change and PFS rate at 6 weeks
6 weeks
To assess safety and tolerability of BMS-690514 and erlotinib
15 months
To estimate the association between efficacy and EGFR copy as measured by FISH for both BMS-690514 and erlotinib
15 months
- +1 more secondary outcomes
Study Arms (2)
A1
EXPERIMENTALB2
ACTIVE COMPARATORInterventions
Tablets, Oral, 200 mg, once daily, Until disease progression or toxicity
Capsules, Oral, 150 mg, once daily, Until disease progression or toxicity
Eligibility Criteria
You may qualify if:
- ECOG PS of 0 or 1
- Histologically confirmed NSCLC
- Adequate amount of tumor (archived or fresh) for biomarker evaluation
- Received one to two regimens of chemotherapy (with at least one platinum-containing)
- Serum creatinine of less than 1.0 mg/dL or a 24 hour creatinine clearance of greater than 60 mL/min
- Stable control of blood pressure on agents other than calcium channel blockers
- Women of child-bearing potential must avoid pregnancy or maintain adequate contraception
- Must be able to swallow pills and take the medications at the same time every day on an empty stomach
You may not qualify if:
- ECOG PS 2 or greater
- Women unwilling to avoid pregnancy or use adequate contraception
- Symptomatic brain metastases
- Recent history of TIA, CVA, or thrombotic/thromboembolic event (within 6 months)
- History of hemoptysis greater than 10 mL/day
- Significant cardiovascular disease
- Uncontrolled diarrhea, Crohn's disease, ulcerative colitis, or any malabsorptive disease
- History of use of other TKIs
- Uncontrolled hypertension
- HIV+
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (30)
Yale University School Of Medicine
New Haven, Connecticut, 06520, United States
Hematology Oncology, P.C.
Stamford, Connecticut, 06902-3628, United States
Mass General Hospital
Boston, Massachusetts, 02114, United States
Henry Ford Hospital
Detroit, Michigan, 48202-2689, United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
Piedmont Hematology Oncology Associates, Pllc
Winston-Salem, North Carolina, 27103, United States
Oregon Health & Science University
Portland, Oregon, 97239, United States
Hema/Oncology Assoc. Of Nepa
Dunmore, Pennsylvania, 18512, United States
Cancer Center Of The Carolinas
Greenville, South Carolina, 29605, United States
Local Institution
Bahía Blanca, Buenos Aires, Argentina
Local Institution
Buenos Aires, Buenos Aires, Argentina
Local Institution
La Plata, Buenos Aires, 1900, Argentina
Local Institution
Córdoba, Córdoba Province, X5000AAI, Argentina
Local Institution
La Rioja, La Rioja Province, 5300, Argentina
Local Institution
Montreal, Quebec, H3T 1E2, Canada
Local Institution
Sherbrooke, Quebec, J1H 5N4, Canada
Local Institution
Lyon, 69373, France
Local Institution
Marseille, 13915, France
Local Institution
Strasbourg, 67000, France
Local Institution
Toulouse, 31052, France
Local Institution
Villejuif, 94800, France
Local Institution
Otwock, 05-400, Poland
Local Institution
Gyeonggi-do, 410-769, South Korea
Local Institution
Seoul, 135-710, South Korea
Local Institution
Seoul, 138-736, South Korea
Local Institution
Barcelona, 08035, Spain
Local Institution
Madrid, 28046, Spain
Local Institution
Vizcaya, 48903, Spain
Local Institution
Taipei, 100, Taiwan
Local Institution
Taipei, 112, Taiwan
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Bristol-Myers Squibb
Bristol-Myers Squibb
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 27, 2008
First Posted
August 29, 2008
Study Start
March 1, 2009
Primary Completion
August 1, 2010
Study Completion
June 1, 2012
Last Updated
October 12, 2015
Record last verified: 2015-09