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A Phase 2, Randomized Study of MLN0128 (a Dual TORC1/2 Inhibitor), MLN0128+MLN1117 (a PI3KÎ± Inhibitor), Weekly Paclitaxel, or the Combination of Weekly Paclitaxel and MLN0128 in Women With Advanced, Recurrent, or Persistent Endometrial Cancer
Millennium Pharmaceuticals, Inc.
The drugs being evaluated in this study are MLN0128 and MLN1117. MLN0128 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 260 patients. Participants will be randomly assigned (by chance, like flipping a coin) to one of 4 treatment groups:
Paclitaxel 80 mg/m^2 weekly
Paclitaxel 80 mg/m^2 weekly + MLN0128 4 mg 3 consecutive days each week
MLN0128 30 mg weekly
MLN0128 4 mg + MLN1117 200 mg both given 3 consecutive days each week
Participants will receive either Paclitaxel intravenous (IV) weekly, Paclitaxel IV along with MLN0128 orally, MLN0128 orally, or MLN0128 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).