Combination Trial of BMS-690514 in Combination With FOLFIRI and FOLFOX
NCT ID: NCT00479583
Last Updated: 2011-11-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
25 participants
INTERVENTIONAL
2007-09-30
2010-04-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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A
BMS-690514 / FOLFIRI
Tablets / IV, Oral / IV, up to 200 mg / irinotecan 180mg/m2, leucovorin 400 mg/m2, 5FU 400mg/m2 bolus, 2400 mg/m2 inf, once daily / q 2 weeks, up to 24 mos
B
BMS-690514 / FOLFOX
Tablets / IV, Oral / IV, up to 200 mg / oxaliplatin 85 mg/m2, leucovorin 400 mg/m2, 5FU 400mg/m2 bolus, 2400 mg/m2 inf, once daily / q 2 weeks, up to 24 mos
Interventions
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BMS-690514 / FOLFIRI
Tablets / IV, Oral / IV, up to 200 mg / irinotecan 180mg/m2, leucovorin 400 mg/m2, 5FU 400mg/m2 bolus, 2400 mg/m2 inf, once daily / q 2 weeks, up to 24 mos
BMS-690514 / FOLFOX
Tablets / IV, Oral / IV, up to 200 mg / oxaliplatin 85 mg/m2, leucovorin 400 mg/m2, 5FU 400mg/m2 bolus, 2400 mg/m2 inf, once daily / q 2 weeks, up to 24 mos
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
65 Years
ALL
No
Sponsors
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Bristol-Myers Squibb
INDUSTRY
Responsible Party
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Bristol-Myers Squibb
Principal Investigators
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Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
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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
Countries
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Related Links
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Investigator Inquiry form
Other Identifiers
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CA187-005
Identifier Type: -
Identifier Source: org_study_id