drugset / Trial / NCT01653470

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

NCT01653470

Phase 1 Completed 141 enrolled Bristol-Myers Squibb
Non-randomizedParallel-groupOpen-labelTreatment

Summary

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

Timeline

Start
2012-10-12
Primary completion
2017-05-03
Completion
2017-05-08

Drugs

EvaluationDrugModalityDoseRoute
Subject AL101 Small molecule 4 mg Intravenous
Subject AL101 Small molecule 6 mg Intravenous
Subject Paclitaxel Small molecule 80 mg/m2 Intravenous
Subject Paclitaxel Small molecule 200 mg/m2 Intravenous
Background Carboplatin Small molecule Intravenous
Background Irinotecan Small molecule 180 mg/m2 Intravenous
Background Leucovorin Small molecule 400 mg/m2 Intravenous
Background fluorouracil Small molecule 400 mg/m2 Intravenous
Background fluorouracil Small molecule 2400 mg/m2 Intravenous

Indications