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A Phase II Study of MLN0128 Alone and with MLN1117, and Paclitaxel Alone and with MLN0128, in Women with Endometrial Cancer

Full Title

C31004: A Phase 2, Randomized Study of MLN0128 (a Dual TORC1/2 Inhibitor), MLN0128+MLN1117 (a PI3Ka Inhibitor), Weekly Paclitaxel, or the Combination of Weekly Paclitaxel and MLN0128 in Women with Advanced, Recurrent, or Persistent Endometrial Cancer


The purpose of this study is to evaluate the safety and effectiveness of different drug combinations to treat women with advanced, recurrent, or persistent endometrial cancer. Women will be randomly assigned to receive one of these treatments:

  • The investigational drug MLN0128 alone
  • MLN0128 with another investigational drug, MLN1117
  • Paclitaxel
  • Paclitaxel plus MLN0128

MLN0128 (also called sapanisertib) interferes with cancer growth by blocking a protein involved in cancer growth called mTOR. MLN1117 works against cancer by inhibiting a protein called PI3 kinase-alpha. Paclitaxel is a commonly used anticancer drug. MLN0128 and MLN1117 are taken orally (by mouth), and paclitaxel is given intravenously (by vein).


To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have advanced, recurrent, or persistent endometrial cancer that continues to grow despite prior therapy that included a platinum-containing drug.
  • Patients may not have received previous taxane therapy or medications that work against mTOR, PI3 kinase, or other targets of the drugs used in this study.
  • Patients must be able to walk and do routine activities for more than half of their normal waking hours.
  • This study is for women age 18 and older.

For more information about this study and to inquire about eligibility, please contact Dr. Vicky Makker at 646-888-4224.