Combination Trial of BMS-690514 in Combination With FOLFIRI and FOLFOX

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 1

Conditions: Cancer

Treatments: Drug: BMS-690514 / FOLFOX; Drug: BMS-690514 / FOLFIRI

Study type: Interventional

Funder types: Industry

Identifiers

NCT00479583

CA187-005

Details and patient eligibility

About

The purpose of this research study is to determine the highest dose of BMS-690514 that can be safely given in combination with the chemotherapeutic regimens (FOLFIRI and FOLFOX) to patients with advanced cancer

Enrollment: 25 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients eligible for FOLFIRI or FOLFOX therapy
• ECOG performance status score 0-1
• At least 4 weeks since the last chemotherapy, immunotherapy or radiotherapy with:
• At least 4 weeks since anti-cancer hormonal therapy OR targeted therapy (for instance tamoxifen or Tarceva)
• No maximum age for Study Arm A (FOLFOX)
• 18-65 years of age for Study Arm B (FOLFIRI)

Exclusion criteria

• Treatment with other TKIs within the past 4 weeks
• Active inflammatory bowel disease
• Major gastrointestinal surgery which may affect absorption of the drug, any surgery within the last 4 weeks
• History of thromboembolism
• Severe unmanageable diarrhea
• Uncontrolled or significant cardiovascular disease

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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25 participants in 2 patient groups

A

Active Comparator group

Treatment:

Drug: BMS-690514 / FOLFIRI

B

Active Comparator group

Treatment:

Drug: BMS-690514 / FOLFOX