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

Part of paid clinical trials in Los Angeles, California.

Sponsor
Bristol-Myers Squibb
Study ID
NCT01653470
Phase
PHASE1
Status
Completed

Conditions

  • Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Paclitaxel — DRUG
  • 5-Fluorouracil (5FU) — DRUG
  • Carboplatin — DRUG
  • Leucovorin — DRUG
  • Irinotecan — DRUG
  • Paclitaxel — DRUG
  • BMS-906024 — DRUG

Study Details

The purpose of this study is to identify a safe and tolerable dose of BMS-906024 in combination with each of the following three chemotherapy regimens: Paclitaxel, 5FU plus Irinotecan (FOLFIRI), or Carboplatin plus Paclitaxel in subjects with advanced or metastatic solid tumors

Key Dates

Start date
Oct 12, 2012
Status verified
Jan 2020
Primary completion
May 3, 2017
Completion
May 8, 2017

Study Design

Enrollment
141 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: 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
  • Experimental: 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
  • Experimental: 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
  • Experimental: 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
  • Experimental: 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

Primary Outcome Measure

Safety assessment based on reports of adverse events and clinical laboratory tests as graded by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) [ Time Frame: Up to 30 days after the last dose of study medication ]

Locations (1)

FacilityCityStateZIPSite coordinators
Usc/Norris Comprehensive Cancer CenterLos AngelesCalifornia90033-

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By research site
Usc/Norris Comprehensive Cancer Center· Los Angeles, CA

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