drugset
drugset / Trial / NCT02393209

Docetaxel With or Without TAK-117 (MLN1117) in Participants With Locally Advanced or Metastatic Non-small Cell Lung Cancer

NCT02393209 ↗

Phase 1/2 Terminated 14 enrolled Millennium Pharmaceuticals, Inc.
RandomizedParallel-groupOpen-labelTreatment

Summary

The purpose of this study is to determine the recommended phase 2 dose (RP2D) of TAK-117 when administered in combination with docetaxel in participants with non-small cell lung cancer (NSCLC) and to evaluate efficacy, safety, and tolerability of TAK-117 administered alone and in combination with docetaxel at the RP2D in participants with locally advanced or metastatic non-small cell lung cancer.

Timeline

Start
2015-06-03
Primary completion
2017-01-12
Completion
2017-01-20

Drugs

EvaluationDrugModalityDoseRoute
Subject Docetaxel Small molecule 36 mg/m2 Intravenous
Subject Docetaxel Small molecule 75 mg/m2 Intravenous
Subject Serabelisib Small molecule 200 mg Oral
Subject Serabelisib Small molecule 300 mg Oral

Indications

non-small cell lung carcinoma