A Study of Sapanisertib, Combination of Sapanisertib With MLN1117, Paclitaxel and Combination of Sapanisertib With Paclitaxel in Women With Endometrial Cancer

Phase 2 Completed 241 enrolled Millennium Pharmaceuticals, Inc. European Network of Individualized Treatment in Endometrial Cancer - ENITEC · collab European Network of Translational Research in Ovarian Cancer - EUTROC · collab

RandomizedParallel-groupOpen-labelTreatment

Summary

The primary purpose of this study is to determine if sapanisertib in combination with weekly paclitaxel improves progression-free survival (PFS) compared to weekly paclitaxel alone.

Timeline

Start: 2016-04-01
Primary completion: 2019-07-02
Completion: 2020-10-30

Outcome

Missed primary endpoint

paper The primary endpoint was not met and toxicity was manageable. PMID 37839313 ↗

registry p =0.178; Hazard Ratio (HR) 0.80 (95% CI 0.58 to 1.12); Stratified Log-rank Test NCT02725268 ↗

Publications

Han SN, Oza A, Colombo N, Oaknin A, Raspagliesi F, Wenham RM, Braicu EI, Jewell A, Makker V, Krell J, Alia EMG, Baurain JF, Su Z, Neuwirth R, Vincent S, Sedarati F, Faller DV, Scambia G. A randomized phase 2 study of sapanisertib in combination with paclitaxel versus paclitaxel alone in women with advanced, recurrent, or persistent endometrial cancer. Gynecol Oncol. 2023 Nov;178:110-118. doi: 10.1016/j.ygyno.2023.09.013. Epub 2023 Oct 14.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Paclitaxel	Small molecule	80 mg/m2	Intravenous
Subject	Sapanisertib	Small molecule	4 mg	Oral
Subject	Sapanisertib	Small molecule	30 mg	Oral
Subject	Serabelisib	Small molecule	200 mg	Oral