a study on Endometrial Neoplasms
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.
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
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:
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).
Endometrial Neoplasms Drug Therapy Paclitaxel Albumin-Bound Paclitaxel
Open to females ages 18 years and up
Female patients who:
Clinical laboratory values as specified below within 4 weeks before the first dose of study drug:
History of any of the following within the last 6 months before administration of the first dose of study drug:
Significant active cardiovascular or pulmonary disease before administration of the first dose of study drug, including:
We will not share your information with anyone other than the team in charge of this study. Submitting your contact information does not obligate you to participate in research.
The study team should get back to you in a few business days.
You will also receive an email with next steps. Check your junk/spam folder if needed.
If you do not hear from the study team, please call 888-689-8273 and tell them you’re interested in study number NCT02725268.
© The Regents of the University of California