CT837 : 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

Female<br/>OnlyGender Female
Only

RecruitingStatus Recruiting

Systemic<br/>Therapy TrialTypeSystemic
Therapy Trial

TwoPhase Two

18+Age Over 18

Female Reproductive<br/>System CancersCancer LocationFemale Reproductive
System Cancers

Systemic therapy | Female reproductive organsEndometrium

Trial Overview Read MoreRead more

This phase II trial is trying to determine what effect adding an oral drug (MLN1028) to weekly paclitaxel will have in the treatment of advanced, recurrent or persistant Endometrial Cancer .
 

This trial is treating patients with Endometrial Cancer.

This is a systemic therapy trial.

You may be able to join this trial if:

  • You are able to swallow medication by mouth.
  • You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.
  • You have had treatment, but your cancer has come back.
  • Your cancer has spread to other parts of the body.

You may be excluded from this trial if:

  • You have a certain disease or psychological condition.
  • You have been diagnosed with a prior or secondary type of cancer.
  • You have had certain treatments, surgical procedures or drugs.

Clinical trials have complex eligibility criteria - talk to your doctor about your interest in this trial.

Clinical Summary Read MoreRead more

Trial Identifiers

Use the hyperlinks, where available to access additional clinical trial information.

Scientific 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

Commercial Sponsor

Millennium Pharmaceuticals, Inc.

Summary

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).

Recruiting Hospitals Read MoreRead more

Monash Health, Medical Oncology
Clayton
Ms Karen Gillett
Karen.Gillett@monashhealth.org
(03) 8572 2018

Not Recruiting Hospitals Read MoreRead more

Closed

Cabrini Education and Research Precinct
Malvern
Li Hoon Lai
lihoonlai@cabrini.com.au
(03) 9508 3421

Western Health - Sunshine Hospital
St Albans
Ms Heike Raunow
Heike.Raunow@wh.org.au
03 8395 9167

Trial Overview: General information about a clinical trial. This section provides an overview of who might be able to join this trial and what type of treatment is involved.

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