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Treatment of Milademetan Versus Trabectedin in Patient With Dedifferentiated Liposarcoma

NCT04979442 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 175

Last updated 2025-01-14

Study results available
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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.

Conditions

  • Dedifferentiated Liposarcoma

Interventions

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

Sponsors & Collaborators

  • Rain Oncology Inc

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-07-14
Primary Completion
2023-10-01
Completion
2023-10-01
FDA Drug
Yes

Countries

  • United States
  • Austria
  • Belgium
  • Canada
  • France
  • Georgia
  • Germany
  • Hong Kong
  • Ireland
  • Italy
  • Poland
  • South Korea
  • Spain
  • Taiwan
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04979442 on ClinicalTrials.gov