Treatment of Milademetan Versus Trabectedin in Patient With Dedifferentiated Liposarcoma (MANTRA)
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|ClinicalTrials.gov Identifier: NCT04979442|
Recruitment Status : Active, not recruiting
First Posted : July 28, 2021
Last Update Posted : August 5, 2022
|Condition or disease||Intervention/treatment||Phase|
|Dedifferentiated Liposarcoma||Drug: RAIN-32 Drug: Trabectedin||Phase 3|
Approximately 160 patients will be randomly assigned in a 1:1 ratio to receive milademetan or trabectedin. Randomization will be stratified by the ECOG performance status (0 or 1) and number of prior treatments (≤ 2 or > 2) for the patient's liposarcoma.
Patients will receive study drug (i.e., milademetan or trabectedin) until reaching unequivocal disease progression (RECIST v.1.1) as determined by the Investigator, experiencing unmanageable toxicity, or until other treatment discontinuation criteria are met. Patients may be treated beyond tumor progression if they are experiencing clinical benefit based on the assessment of the Investigator in discussion with the Medical Monitor. All patients will be followed for documentation of disease progression and survival information (i.e., date and cause of death) and subsequent treatment information (i.e., date/duration of treatment, response, and subsequent disease progression). Long-term follow-up will continue every 12 weeks (± 7 days) until the endpoint of death, the patient is lost to follow-up, or for 24 months following the final dose of study drug, whichever comes first.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||160 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Randomized Multicenter Phase 3 Study of Milademetan Versus Trabectedin in Patients With Dedifferentiated Liposarcoma|
|Actual Study Start Date :||July 14, 2021|
|Estimated Primary Completion Date :||July 2025|
|Estimated Study Completion Date :||July 2025|
Experimental: RAIN-32 (Milademetan)
260 mg once daily orally on Days 1 to 3 and Days 15 to 17 of each 28-day cycle.
260 mg once daily orally on Days 1 to 3 and Days 15 to 17 of each 28-day cycle
Other Name: Milademetan
Active Comparator: Trabectedin
1.5 mg/m2 body surface area as a 24-hour IV infusion, every 3 weeks.
1.5 mg/m2 body surface area as a 24-hour IV infusion, every 3 weeks
Other Name: Yondelis
- Compare progression-free survival (PFS) as determined by Blinded Independent Central Review (BICR) between the milademetan treatment arm and trabectedin control arm [ Time Frame: 4 years ]
- Overall survival (OS) [ Time Frame: 4 years ]OS as measured from the date of randomization to date of death by any cause
- Disease control rate (DCR) [ Time Frame: 4 years ]DCR defined as the percentage of patients who have achieved CR, PR, or SD for ≥ 8 weeks
- Objective response rate (ORR) [ Time Frame: 4 years ]ORR defined as the percentage of patients who achieve a confirmed CR or PR
- Duration of response (DOR) [ Time Frame: 4 years ]DOR defined as the time from date of first response to date of disease progression or death
- PFS by Investigator assessments [ Time Frame: 4 years ]PFS defined as the time from randomization to the earliest date of the first objective documentation of radiographic disease progression or death due to any cause, based on Investigator assessments
- Number of participants with treatment-emergent adverse events until approximately 30 days after the last study drug [ Time Frame: 4 years ]
- Evaluate the patient-reported outcomes by using the European Organisation for Research and Treatment of Cancer Quality-of-Life Questionnaire, Core 30 (QLQ-C30) [ Time Frame: 4 years ]
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): NCT04979442