A Phase I Study of BMS-690514 in Patients With Advanced or Metastatic Solid Tumors

• Status: Completed
• Trial end date: 2009-07-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this research study is to determine the highest dose of the drug (BMS-690514) that can be safely given to patients with advanced cancer.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bristol-Myers Squibb

Criteria

Inclusion Criteria:

• Men and women 18 and older

• Diagnosis of any solid tumor

• ECOG performance status score 0-1

• Prior chemo-therapy, immunotherapy or radiotherapy with at least 4 weeks since the last treatment

• Treatment with VEGFR2 or HER1 TKI allowed but not both (for instance Avastin or Tarceva, but not both)

Exclusion Criteria:

• Treatment with other TKIs within the past 4 weeks

• Patients with brain metastasis

• Patients with centrally located squamous cell carcinoma of the lung

• Major gastrointestinal surgery which may affect absorption of the drug

• Any surgery within last 4 weeks

• History of thromboembolism

• Severe unmanageable diarrhea

• Subjects in Part B will have Non-Small Cell Lung Cancer (NSCLC)

• Part B/Cohort I erlotinib-naive subjects

• Part B/Cohort II subjects who have experienced disease progression while receiving erlotinib (erlotinib-resistant subjects)