Clinical trial · Interventional
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
A Phase Ib Ascending Multi-arm, Dose Escalation Study of BMS-906024 Combined With Several Chemotherapy Regimens in Subjects With Advanced or Metastatic Tumors
NCT01653470CI-TRIAL-00043044completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 5-Fluorouracil (5FU) | Drug | Fluorouracil | ALIAS |
| BMS-906024 | Drug | — | UNRESOLVED |
| Carboplatin | Drug | Carboplatin | ALIAS |
| Irinotecan | Drug | Irinotecan | ALIAS |
| Leucovorin | Drug | Leucovorin | ALIAS |
| Paclitaxel | Drug | Paclitaxel | ALIAS |
Design
Arms and outcomes
Arms (5)
- type
- EXPERIMENTAL
- label
- Arm A: Paclitaxel + BMS-906024
- 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
- interventionNames
- Drug: Paclitaxel
- Drug: BMS-906024
- type
- EXPERIMENTAL
- label
- Arm B: FOLFIRI (5FU, Leucovorin, Irinotecan) + BMS-906024
- 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
- interventionNames
- Drug: 5-Fluorouracil (5FU)
- Drug: Leucovorin
- Drug: Irinotecan
- Drug: BMS-906024
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.