Safety and Efficacy Study of BMS-908662 Alone or in Combination With Cetuximab in Subjects With K-RAS or B-RAF Mutation Positive Advanced or Metastatic Colorectal Cancer
NCT ID: NCT01086267
Last Updated: 2016-06-27
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/PHASE2
17 participants
INTERVENTIONAL
2010-07-31
2011-08-31
Brief Summary
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Detailed Description
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Phase 2: Randomized Controlled, Parallel
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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BMS-908662 (A1)
Phase 1
BMS-908662
Capsules, Oral, escalating doses starting at 25 mg, every 12 hours (Q 12 h), Continuously
Cetuximab (A1)
Phase 1
Cetuximab
Vial, IV, 400 mg/m² loading dose followed by 250 mg/m² maintenance dose, Weekly, Continuously
BMS-908662 (B1)
Phase 2
BMS-908662
Capsules, Oral, (TBD) mg, Q 12 h, Continuously
BMS-908662 + Cetuximab (B2)
Phase 2
BMS-908662
Capsules, Oral, (TBD) mg, Q 12 h, Continuously
Cetuximab
Vial, IV, 400 mg/m² loading dose followed by 250 mg/m² maintenance dose, Weekly, Continuously
Interventions
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BMS-908662
Capsules, Oral, escalating doses starting at 25 mg, every 12 hours (Q 12 h), Continuously
BMS-908662
Capsules, Oral, (TBD) mg, Q 12 h, Continuously
Cetuximab
Vial, IV, 400 mg/m² loading dose followed by 250 mg/m² maintenance dose, Weekly, Continuously
Eligibility Criteria
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Inclusion Criteria
* Histologic or cytologic confirmation of the diagnosis.
* Eastern Cooperative Oncology Group (ECOG) ≤ 1
* Adequate organ \& marrow function.
Exclusion Criteria
* Phase 2: Prior therapy with a RAF inhibitor.
18 Years
ALL
No
Sponsors
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Bristol-Myers Squibb
INDUSTRY
Responsible Party
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Principal Investigators
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Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
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Oncology Research Associates D/B/A
Scottsdale, Arizona, United States
Usc Norris Comprehensive Cancer Center
Los Angeles, California, United States
Local Institution
Ottawa, Ontario, Canada
Countries
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Related Links
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Investigator Inquiry form
Other Identifiers
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2010-018944-15
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CA206-001
Identifier Type: -
Identifier Source: org_study_id
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