Study to Evaluate Safety & Tolerability of BMS-906024 in Combination With Chemotherapy & to Define DLTs & MTD of BMS-906024 in Combination With One of the Following Chemotherapy Regimens; Weekly Paclitaxel, 5FU+Irinotecan or Carboplatin+Paclitaxel in Subjects With Advanced / Metastatic Solid Tumors
NCT ID: NCT01653470
Last Updated: 2020-01-28
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
141 participants
INTERVENTIONAL
2012-10-12
2017-05-08
Brief Summary
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Detailed Description
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MTD = Maximum tolerated dose
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Arm F: Carboplatin/Paclitaxcel and BMS-906024
Carboplatin AUC 6 / Paclitaxel 200 mg/m2 solution once every 3 weeks and BMS-906024 4 mg or 6 mg solution once every 3 weeks intravenously continuously until disease progression or unacceptable toxicity
Carboplatin
Paclitaxel
BMS-906024
Arm A: Paclitaxel + BMS-906024
Paclitaxel 80 mg/m2 solution and BMS-906024 4 mg or 6 mg solution intravenously once weekly continuously until disease progression or unacceptable toxicity
Paclitaxel
BMS-906024
Arm B: FOLFIRI (5FU, Leucovorin, Irinotecan) + BMS-906024
5FU Bolus 400 mg/m2, 5FU Infusion 2400 mg/m2, Irinotecan 180 mg/m2 solution, Leucovorin 400 mg/m2 solution intravenously once every 2 weeks and BMS- 906024 4 mg or 6 mg solution intravenously once weekly continuously until disease progression or unacceptable toxicity
5-Fluorouracil (5FU)
Leucovorin
Irinotecan
BMS-906024
Arm C: Carboplatin/Paclitaxel + BMS-906024
Carboplatin AUC 6 / Paclitaxel 200 mg/m2 solution once every 3 weeks and BMS-906024 4 mg or 6 mg solution once weekly intravenously continuously until disease progression or unacceptable toxicity
Carboplatin
Paclitaxel
BMS-906024
Arm D: Paclitaxel + BMS-906024
Paclitaxel 80 mg/m2 solution once weekly and BMS-906024 4 mg or 6 mg solution once every 2 weeks intravenously continuously until disease progression or unacceptable toxicity
Paclitaxel
BMS-906024
Interventions
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Paclitaxel
5-Fluorouracil (5FU)
Carboplatin
Leucovorin
Irinotecan
Paclitaxel
BMS-906024
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Subjects with non-small cell lung cancer and triple-negative breast cancer are preferred
* Biopsy accessible tumor (may use archived tumor samples under certain circumstances)
* Life expectancy of at least 3 months
* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1
* Measurable disease
Exclusion Criteria
* Infection
* Gastrointestinal (GI) disease with increased risk of diarrhea (e.g. inflammatory bowel disease)
* Uncontrolled or significant cardiovascular disease
* Subjects taking medications known to increase risk of Torsades de Pointes
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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Usc/Norris Comprehensive Cancer Center
Los Angeles, California, United States
Local Institution
Brussels, , Belgium
Local Institution
Edmonton, Alberta, Canada
Local Institution
Toronto, Ontario, Canada
Local Institution
Ottawa, Quebec, Canada
Countries
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Related Links
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BMS Clinical Trial Information
BMS Clinical Trial Patient Recruiting
Investigator Inquiry Form
FDA Safety Alerts and Recalls
Other Identifiers
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2012-003232-23
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CA216-003
Identifier Type: -
Identifier Source: org_study_id
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