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

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 1

Conditions: Cancer

Treatments: Drug: BMS-906024; Drug: Paclitaxel; Drug: Irinotecan; Drug: 5-Fluorouracil (5FU); Drug: Carboplatin; Drug: Leucovorin

Study type: Interventional

Funder types: Industry

Identifiers

NCT01653470

CA216-003

2012-003232-23 (EudraCT Number)

Details and patient eligibility

About

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

Full description

DLTs = dose-limiting toxicities

MTD = Maximum tolerated dose

Enrollment: 141 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com.

Inclusion Criteria:

• Subjects with advanced or metastatic solid tumors for whom a chemotherapy regimen is considered appropriate
• 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:

• Uncontrolled brain metastases
• 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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141 participants in 5 patient groups

Arm A: Paclitaxel + BMS-906024

Experimental group

Description:

Paclitaxel 80 mg/m2 solution and BMS-906024 4 mg or 6 mg solution intravenously once weekly continuously until disease progression or unacceptable toxicity

Treatment:

Drug: BMS-906024

Drug: Paclitaxel

Drug: Paclitaxel

Arm B: FOLFIRI (5FU, Leucovorin, Irinotecan) + BMS-906024

Experimental group

Description:

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

Treatment:

Drug: 5-Fluorouracil (5FU)

Drug: Leucovorin

Drug: Irinotecan

Drug: BMS-906024

Arm C: Carboplatin/Paclitaxel + BMS-906024

Experimental group

Description:

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

Treatment:

Drug: Carboplatin

Drug: BMS-906024

Drug: Paclitaxel

Drug: Paclitaxel

Arm D: Paclitaxel + BMS-906024

Experimental group

Description:

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

Treatment:

Drug: BMS-906024

Drug: Paclitaxel

Drug: Paclitaxel

Arm F: Carboplatin/Paclitaxcel and BMS-906024

Experimental group

Description:

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

Treatment:

Drug: Carboplatin

Drug: BMS-906024

Drug: Paclitaxel

Drug: Paclitaxel