NCT04979442

Treatment of Milademetan Versus Trabectedin in Patient With Dedifferentiated Liposarcoma

A Randomized Multicenter Phase 3 Study of Milademetan Versus Trabectedin in Patients With Dedifferentiated Liposarcoma

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 175 (actual)
• Sponsor: Rain Oncology Inc · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Randomized, multicenter, open-label, Phase 3 registration study designed to evaluate the safety and efficacy of milademetan compared to trabectedin in patients with unresectable (i.e., where resection is deemed to cause unacceptable morbidity or mortality) or metastatic DD liposarcoma that progressed on 1 or more prior systemic therapies, including at least 1 anthracycline-based therapy.

Detailed description

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.

Conditions

• Dedifferentiated Liposarcoma

Interventions

Type	Name	Description
DRUG	RAIN-32	260 mg once daily orally on Days 1 to 3 and Days 15 to 17 of each 28-day cycle
DRUG	Trabectedin	1.5 mg/m2 body surface area as a 24-hour IV infusion, every 3 weeks

Timeline

• Start date: 2021-07-14
• Primary completion: 2023-10-01
• Completion: 2023-10-01
• First posted: 2021-07-28
• Last updated: 2025-01-14
• Results posted: 2025-01-14

Locations

71 sites across 15 countries: United States, Austria, Belgium, Canada, France, Georgia, Germany, Hong Kong, Ireland, Italy, Poland, South Korea, Spain, Taiwan, United Kingdom

Regulatory

• FDA-regulated drug study