Phase 2 Study of MLN0128, Combination of MLN0128 With MLN1117, Paclitaxel and Combination of MLN0128 With Paclitaxel in Women With Endometrial Cancer

Official Title

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

Summary:

The primary purpose of this study is to determine if MLN0128 in combination with weekly paclitaxel improves progression-free survival (PFS) compared to weekly paclitaxel alone.

Trial Description

Primary Outcome:

  • Progression Free Survival (PFS)
Secondary Outcome:
  • Percentage of Participants who Experience at Least One Treatment-emergent Adverse Event (TEAE)
  • Overall Survival (OS)
  • Time to Progression (TTP)
  • Overall Response Rate (ORR)
  • Clinical Benefit Rate (CBR)
  • Clinical Benefit Rate (CBR) at Week 16 (CBR-16)
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 242 participants. 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 multicentre, 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).

View this trial on ClinicalTrials.gov

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Resources

Canadian Cancer Society

These resources are provided in partnership with the Canadian Cancer Society