TAS-117 in Patients With Advanced Solid Tumors Harboring Germline PTEN Mutations

Phase 1 Terminated 17 enrolled Taiho Oncology, Inc.

Non-randomizedParallel-groupOpen-labelTreatment

Summary

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and antitumor activity of TAS-117 in patients with advanced or metastatic solid tumors (excluding primary brain tumors) harboring germline PTEN inactivating mutations.

Timeline

Start: 2021-03-31
Primary completion: 2023-02-28
Completion: 2023-03-06

Outcome

Outcome not reported

Stopped (Enrollment): “The Sponsor had decided to terminate this clinical trial due to an insufficient rate of accrual of patients.”

Publications

Rodon J, Funchain P, Laetsch TW, Arkenau HT, Hervieu A, Singer CF, Murciano-Goroff YR, Chawla SP, Anthony K, Yamamiya I, Liu M, Halim AB, Benhadji KA, Takahashi O, Delaloge S. A phase II study of TAS-117 in patients with advanced solid tumors harboring germline PTEN-inactivating mutations. Future Oncol. 2022 Sep;18(30):3377-3387. doi: 10.2217/fon-2022-0305. Epub 2022 Aug 30.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	PIFUSERTIB	Small molecule	—	Oral