drugset
drugset / Trial / NCT01899053

A Safety and Pharmacokinetic Study of TAK-228 in Combination With TAK-117 in Adult Participants With Advanced Nonhematologic Malignancies

NCT01899053 ↗

Phase 1 Completed 101 enrolled Millennium Pharmaceuticals, Inc.
Non-randomizedParallel-groupOpen-labelTreatment

Summary

The purpose of this study was to evaluate the safety and to determine dose-limiting toxicities (DLTs), maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D), and dosing schedules of oral TAK-228+TAK-117. It also evaluated the single- and multiple-dose plasma pharmacokinetics (PK) of TAK-228+TAK-117 in participants with advanced nonhematologic malignancies.

Timeline

Start
2013-06-28
Primary completion
2017-01-31
Completion
2018-04-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Sapanisertib Small molecule 2 mg Oral
Subject Sapanisertib Small molecule 3 mg Oral
Subject Sapanisertib Small molecule 4 mg Oral
Subject Sapanisertib Small molecule 6 mg Oral
Subject Sapanisertib Small molecule 8 mg Oral
Subject Serabelisib Small molecule 100 mg Oral
Subject Serabelisib Small molecule 200 mg Oral
Subject Serabelisib Small molecule 300 mg Oral
Subject Serabelisib Small molecule 400 mg Oral

Indications

neoplasm