NCT02725268

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

A Phase 2, Randomized Study of MLN0128 (a Dual TORC1/2 Inhibitor), MLN0128+MLN1117 (a PI3Kα Inhibitor), Weekly Paclitaxel, or the Combination of Weekly Paclitaxel and MLN0128 in Women With Advanced, Recurrent, or Persistent Endometrial Cancer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 241 (actual)
• Sponsor: Millennium Pharmaceuticals, Inc. · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The drugs being evaluated in this study are sapanisertib and MLN1117. Sapanisertib is being evaluated as a single agent and in combination with paclitaxel or MLN1117 to treat women with advanced, recurrent, or persistent endometrial cancer. This study will evaluate the efficacy and safety of each drug or drug combination. The study will enroll approximately 241 participants. Participants will be randomly assigned (by chance, like flipping a coin) to one of 4 treatment groups: * Paclitaxel 80 mg/m\^2 * Paclitaxel 80 mg/m\^2 + Sapanisertib 4 mg * Sapanisertib 30 mg * Sapanisertib 4 mg + MLN1117 200 mg Participants will receive either paclitaxel intravenous (IV) weekly, Paclitaxel IV along with sapanisertib orally, sapanisertib orally, or sapanisertib and MLN1117 orally. This is a multicenter, multinational trial. Participants will make multiple visits to the clinic, with an end of treatment visit (EOT) which will occur 30 to 40 days after receiving their last dose of study drug or before the start of any subsequent anticancer therapy. After EOT, participants will be followed for PFS and overall survival (OS).

Conditions

• Endometrial Neoplasms

Interventions

Type	Name	Description
DRUG	Paclitaxel	Paclitaxel intravenous solution.
DRUG	Sapanisertib	Sapanisertib capsules.
DRUG	MLN1117	MLN1117 capsules.

Timeline

• Start date: 2016-04-01
• Primary completion: 2019-07-02
• Completion: 2020-10-30
• First posted: 2016-03-31
• Last updated: 2021-11-24
• Results posted: 2020-06-09

Locations

78 sites across 10 countries: United States, Australia, Belgium, Canada, Germany, Italy, Netherlands, Norway, Spain, United Kingdom

Regulatory

• FDA-regulated drug study