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

Completed · Phase 1

Conditions studied: Cancer

In brief

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

Key facts

Study ID

NCT00479583

Run by

Bristol-Myers Squibb

People needed

25

Starts

2007-09-01

Expected to finish

2010-04-01

Last updated by the study team

2011-11-30

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

Where it is running

• University Of Alabama At Birmingham — Birmingham, Alabama, United States
• Fox Chase Cancer Center — Philadelphia, Pennsylvania, United States
• Local Institution — Saint-Herblain, France
• Local Institution — Villejuif, France

Full record on ClinicalTrials.gov

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