Sapanisertib and Serabelisib (PIKTOR) With Paclitaxel and a Substudy With an Insulin-Suppressing Diet in Patients With Advanced/Recurrent Endometrial Cancer

Phase 2 Recruiting 40 enrolled Faeth Therapeutics GOG Foundation · collab

NaSingle-groupOpen-labelTreatment

Summary

This is a Phase 2, multicenter, open-label, single-arm study to evaluate the efficacy and safety of sapanisertib and serabelisib (PIKTOR) with paclitaxel in participants with advanced or recurrent endometrial cancer.

Timeline

Start: 2024-12-12
Primary completion: 2028-09
Completion: 2029-09

Publications

Background 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	Sapanisertib	Small molecule	—	Oral
Subject	Serabelisib	Small molecule	—	Oral
Background	Paclitaxel	Small molecule	—	Intravenous

Sapanisertib and Serabelisib (PIKTOR) With Paclitaxel and a Substudy With an Insulin-Suppressing Diet in Patients With Advanced/Recurrent Endometrial Cancer

Summary

Timeline

Publications

Drugs

Indications