Phase 2 Study of MLN0128, Combination of MLN0128 With MLN1117, Paclitaxel and Combination of MLN0128 With Paclitaxel in Women With Endometrial Cancer
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02725268|
Recruitment Status : Recruiting
First Posted : March 31, 2016
Last Update Posted : September 7, 2018
|Condition or disease||Intervention/treatment||Phase|
|Endometrial Neoplasms||Drug: Paclitaxel Drug: MLN0128 Drug: MLN1117||Phase 2|
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 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).
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||242 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
|Actual Study Start Date :||April 1, 2016|
|Estimated Primary Completion Date :||February 28, 2019|
|Estimated Study Completion Date :||September 30, 2019|
Experimental: Paclitaxel 80 mg/m^2
Paclitaxel 80 milligram per square meter (mg/m^2), IV, weekly on Days 1, 8, and 15 of a 28-day cycle until disease progression, unacceptable toxicity, or withdraw consent.
Paclitaxel intravenous solution
Experimental: Paclitaxel 80 mg/m^2 + MLN0128 4 mg
Paclitaxel 80 mg/m^2, IV, weekly on Days 1, 8, and 15 of a 28-day cycle along with MLN0128 4 mg, capsule, orally on Days 2-4, 9-11, 16-18, and 23-25 of a 28-day cycle until disease progression, unacceptable toxicity, or withdraw consent.
Paclitaxel intravenous solution
Experimental: MLN0128 30 mg
MLN0128 30 milligram (mg), capsule, orally, once weekly on Days 1, 8, 15, and 22 of a 28-day cycle until disease progression, unacceptable toxicity, or withdraw consent.
Experimental: MLN0128 4 mg + MLN1117 200 mg
MLN0128 4 mg, capsule, orally and MLN1117 200 mg, capsule, orally on Days 1-3, 8-10, 15-17, and 22-24 of a 28-day cycle until disease progression, unacceptable toxicity, or withdraw consent.
- Progression Free Survival (PFS) [ Time Frame: Up to 30 months ]PFS is defined as the time from the date of randomization to the date of first documentation of progressive disease or death due to any cause, whichever occurs first. For a participant who has not progressed and is last known to be alive, PFS will be censored at the last response assessment that is stable disease (SD) or better.
- Percentage of Participants who Experience at Least One Treatment-emergent Adverse Event (TEAE) [ Time Frame: From the first dose of study drug through 30 days after the last dose of study drug (Up to 30 Months) ]
- Overall Survival (OS) [ Time Frame: Up to 30 months ]OS is defined as the time from the date of randomization to the date of death. Participants without documentation of death at the time of analysis will be censored at the date last known to be alive.
- Time to Progression (TTP) [ Time Frame: Up to 30 months ]TTP is defined as the time from the date of randomization to the date of first documentation of progression. For a participant who has not progressed, TTP will be censored at the last response assessment that is SD or better.
- Overall Response Rate (ORR) [ Time Frame: Up to 30 months ]ORR is defined as the percentage of participants who achieve a best response of a complete response (CR) or partial response (PR) using Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1. CR: Disappearance of all target lesions, non-target lesions, no new lesions, and normalization of tumor marker level. PR: At least a 30% decrease in the sum of diameters of target lesions, no progression in non-target lesion, and no new lesions.
- Clinical Benefit Rate (CBR) [ Time Frame: Up to 30 months ]CBR is defined as the percentage of participants with CR or PR or SD.
- Clinical Benefit Rate (CBR) at Week 16 (CBR-16) [ Time Frame: Up to 30 months ]CBR-16 is defined as the percentage of participants who achieve CR or PR of any duration or have SD with a duration of at least 16 weeks.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02725268
|Contact: Takeda Study Registration Call Center||+1-866-835-2233||GlobalOncologyMedinfo@takeda.com|
Show 75 Study Locations
|Study Director:||Medical Monitor||Millennium Pharmaceuticals, Inc.|