Evaluation of the Safety and Tolerability of TAK-228 With TAK-117 and Paclitaxel in Advanced Solid Tumors

Phase 1 Completed 19 enrolled Avera McKennan Hospital & University Health Center

Non-randomizedSequentialOpen-labelTreatment

Summary

This is an open-label, cohort study to determine the feasibility and tolerability of the combination of TAK-228 and TAK-117 given on days 2-4, 9-11, 16-18, and 23-25 with paclitaxel on days 1, 8, and 15 for one 28-day cycle in patients with advanced solid tumors.

Timeline

Start: 2017-07-06
Primary completion: 2020-11-20
Completion: 2022-11-20

Publications

Starks DC, Rojas-Espaillat L, Meissner T, Williams CB. Phase I dose escalation study of dual PI3K/mTOR inhibition by Sapanisertib and Serabelisib in combination with paclitaxel in patients with advanced solid tumors. Gynecol Oncol. 2022 Sep;166(3):403-409. doi: 10.1016/j.ygyno.2022.07.005. Epub 2022 Jul 15.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Paclitaxel	Small molecule	60 mg/m2	—
Subject	Paclitaxel	Small molecule	80 mg/m2	—
Subject	Sapanisertib	Small molecule	2 mg	Oral
Subject	Sapanisertib	Small molecule	3 mg	Oral
Subject	Sapanisertib	Small molecule	4 mg	Oral
Subject	Serabelisib	Small molecule	100 mg	Oral
Subject	Serabelisib	Small molecule	200 mg	Oral

Indications

No indication recorded.