A Comparison Between BMS-690514 and Erlotinib in Patients Who Were Previously Treated for NSCLC
Completed · Phase 2
Conditions studied: Non Small Cell Lung Cancer
In brief
The purpose of this study is to improve disease control and survival for patients who were treated with chemotherapy using BMS-690514 over erlotinib
Key facts
- Study ID
- NCT00743938
- Run by
- Bristol-Myers Squibb
- People needed
- 141
- Starts
- 2009-03-01
- Expected to finish
- 2012-06-01
- Last updated by the study team
- 2015-10-12
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
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+
Where it is running
- Yale University School Of Medicine — New Haven, Connecticut, United States
- Hematology Oncology, P.C. — Stamford, Connecticut, United States
- Mass General Hospital — Boston, Massachusetts, United States
- Henry Ford Hospital — Detroit, Michigan, United States
- Memorial Sloan Kettering Cancer Center — New York, New York, United States
- Piedmont Hematology Oncology Associates, Pllc — Winston-Salem, North Carolina, United States
- Oregon Health & Science University — Portland, Oregon, United States
- Hema/Oncology Assoc. Of Nepa — Dunmore, Pennsylvania, United States
- Cancer Center Of The Carolinas — Greenville, South Carolina, United States
- Local Institution — Bahía Blanca, Buenos Aires, Argentina
- Local Institution — Buenos Aires, Buenos Aires, Argentina
- Local Institution — La Plata, Buenos Aires, Argentina
- Local Institution — Córdoba, Córdoba Province, Argentina
- Local Institution — La Rioja, La Rioja Province, Argentina
- Local Institution — Montreal, Quebec, Canada
- Local Institution — Sherbrooke, Quebec, Canada
- Local Institution — Lyon, France
- Local Institution — Marseille, France
- Local Institution — Strasbourg, France
- Local Institution — Toulouse, France
- Local Institution — Villejuif, France
- Local Institution — Otwock, Poland
- Local Institution — Gyeonggi-do, South Korea
- Local Institution — Seoul, South Korea
- Local Institution — Seoul, South Korea
Full record on ClinicalTrials.gov
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