NCT00743938CompletedPhase 2
A Double-Blind, Randomized, Parallel Two-Arm Phase II Trial of BMS-690514 Versus Erlotinib in Previously Treated NSCLC Patients
Bristol-Myers Squibb10 sites in 2 countries141 target enrollmentStarted: March 2009Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Enrollment
- 141
- Locations
- 10
- Primary Endpoint
- To compare the progression-free survival of patients on BMS-690514 with those on erlotinib
Study Overview
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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
A1
Experimental
Intervention: BMS-690514 (Drug)
B2
Active Comparator
Intervention: Erlotinib (Drug)
Outcomes
Primary Outcomes
To compare the progression-free survival of patients on BMS-690514 with those on erlotinib
Time Frame: CT/MRI at baseline and every 6 weeks for 36 weeks
Secondary Outcomes
- 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)
- To obtain samples for population pharmacokinetics for BMS-690514 in previously treated NSCLC patients(Days 1,8,15, 29)
Investigators
Study Sites (10)
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