A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics (PK) of TAK-228 as Single Agent in Adult East Asian Participants With Advanced Nonhematological Malignancies

Phase 1 Terminated 28 enrolled Calithera Biosciences, Inc

Non-randomizedParallel-groupOpen-labelOther

Summary

The purpose of this study is to evaluate the safety and tolerability, recommended phase 2 dose (RP2D), and to characterize PK of TAK-228 administered once daily or once weekly to East Asian participants with advanced nonhematological malignancies.

Timeline

Start: 2018-01-17
Primary completion: 2019-08-28
Completion: 2019-08-28

Publications

Shimizu T, Kuboki Y, Lin CC, Yonemori K, Yanai T, Faller DV, Dobler L, Gupta N, Sedarati F, Kim KP. A Phase 1 Study of Sapanisertib (TAK-228) in East Asian Patients with Advanced Nonhematological Malignancies. Target Oncol. 2022 Jan;17(1):15-24. doi: 10.1007/s11523-021-00855-w. Epub 2021 Nov 29.

Drugs

Evaluation	Drug	Modality	Dose	Route
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	20 mg	Oral
Subject	Sapanisertib	Small molecule	30 mg	Oral

A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics (PK) of TAK-228 as Single Agent in Adult East Asian Participants With Advanced Nonhematological Malignancies

Summary

Timeline

Publications

Drugs

Indications