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

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 1

Conditions: Tumor; Cancer

Treatments: Drug: BMS-690514

Study type: Interventional

Funder types: Industry

Identifiers

NCT00329004

CA187-002

Details and patient eligibility

About

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.

Enrollment: 89 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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89 participants in 1 patient group

1

Experimental group

Treatment:

Drug: BMS-690514