Status:
COMPLETED
A Comparison Between BMS-690514 and Erlotinib in Patients Who Were Previously Treated for NSCLC
Lead Sponsor:
Bristol-Myers Squibb
Conditions:
Non Small Cell Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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+
Key Trial Info
Start Date :
March 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2012
Estimated Enrollment :
141 Patients enrolled
Trial Details
Trial ID
NCT00743938
Start Date
March 1 2009
End Date
June 1 2012
Last Update
October 12 2015
Active Locations (30)
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1
Yale University School Of Medicine
New Haven, Connecticut, United States, 06520
2
Hematology Oncology, P.C.
Stamford, Connecticut, United States, 06902-3628
3
Mass General Hospital
Boston, Massachusetts, United States, 02114
4
Henry Ford Hospital
Detroit, Michigan, United States, 48202-2689