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 enrollmentMarch 2009

Overview

Phase: Phase 2
Intervention: BMS-690514
Conditions: Non Small Cell Lung Cancer
Sponsor: Bristol-Myers Squibb
Enrollment: 141
Locations: 10
Primary Endpoint: To compare the progression-free survival of patients on BMS-690514 with those on erlotinib
Status: Completed
Last Updated: 10 years ago

The purpose of this study is to improve disease control and survival for patients who were treated with chemotherapy using BMS-690514 over erlotinib

Registry

clinicaltrials.gov

Start Date

March 2009

End Date

June 2012

Last Updated

10 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Sponsor

Responsible Party

Sponsor

•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

•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

Intervention: BMS-690514

Intervention: Erlotinib

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

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)