drugset
drugset / Trial / NCT02327169

A Study MLN2480 in Combination With MLN0128 or Alisertib, or Paclitaxel, or Cetuximab, or Irinotecan in Adult Participants With Advanced Nonhematologic Malignancies

NCT02327169 ↗

Phase 1 Completed 81 enrolled Millennium Pharmaceuticals, Inc.
Non-randomizedParallel-groupOpen-labelTreatment

Summary

The primary purpose of this study is to determine the safety profile and the maximum tolerated doses (MTDs)/ potential recommended phase 2 doses (RP2Ds) of the combination treatments of MLN2480 + MLN0128, MLN2480 + alisertib, MLN2480 + paclitaxel, MLN2480 + cetuximab, and MLN2480 + irinotecan in participants with advanced nonhematologic malignancies.

Timeline

Start
2015-01-14
Primary completion
2018-07-02
Completion
2018-07-02

Drugs

EvaluationDrugModalityDoseRoute
Subject Alisertib Small molecule 30 mg Oral
Subject Alisertib Small molecule 40 mg Oral
Subject Cetuximab Monoclonal antibody 250 mg/m2 Intravenous
Subject Irinotecan Small molecule 180 mg/m2 Intravenous
Subject Paclitaxel Small molecule 80 mg/m2 Intravenous
Subject Paclitaxel Small molecule 80 mg Intravenous
Subject Sapanisertib Small molecule 2 mg Oral
Subject Tovorafenib Small molecule 100 mg Oral
Subject Tovorafenib Small molecule 200 mg Oral
Subject Tovorafenib Small molecule 400 mg Oral
Subject Tovorafenib Small molecule 600 mg Oral

Indications

neoplastic disease or syndrome