A Double-Blind, Randomized, Parallel Two-Arm Phase II Trial of BMS-690514 Versus Erlotinib in Previously Treated NSCLC Patients
Phase 2
18 Years
N/A
18 Years
N/A
Not Enrolling
Both
Non Small Cell Lung Cancer
Both
Non Small Cell Lung Cancer
Trial Information
A Double-Blind, Randomized, Parallel Two-Arm Phase II Trial of BMS-690514 Versus Erlotinib in Previously Treated NSCLC Patients
Inclusion Criteria:
- 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 Criteria:
- 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+
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Outcome Measure:
To compare the progression-free survival of patients on BMS-690514 with those on erlotinib
Outcome Time Frame:
CT/MRI at baseline and every 6 weeks for 36 weeks
Safety Issue:
No
Principal Investigator
Bristol-Myers Squibb
Investigator Role:
Study Director
Investigator Affiliation:
Bristol-Myers Squibb
Authority:
United States: Food and Drug Administration
Study ID:
CA187-017
NCT ID:
NCT00743938
Start Date:
March 2009
Completion Date:
June 2012
Related Keywords:
- Non Small Cell Lung Cancer
- Carcinoma, Non-Small-Cell Lung
- Lung Neoplasms
Name | Location |
|---|---|
| Memorial Sloan Kettering Cancer Center | New York, New York 10021 |
| Henry Ford Hospital | Detroit, Michigan 48202 |
| Hematology Oncology, P.C. | Stamford, Connecticut 06902 |
| Oregon Health & Science University | Portland, Oregon 97201 |
| Yale University School Of Medicine | New Haven, Connecticut 06520 |
| Cancer Center of the Carolinas | Greenville, South Carolina 29615 |
| Mass General Hospital | Boston, Massachusetts 02114 |
| Piedmont Hematology Oncology Associates, PLLC | Winston-Salem, North Carolina |
| Hema/Oncology Assoc. Of Nepa | Dunmore, Pennsylvania 18512 |
