A Comparison Between BMS-690514 and Erlotinib in Patients Who Were Previously Treated for NSCLC

• Status: Completed
• Trial end date: 2012-06-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bristol-Myers Squibb
• Treatments: Erlotinib Hydrochloride

Criteria

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+