drugset / Trial / NCT04979442
Treatment of Milademetan Versus Trabectedin in Patient With Dedifferentiated Liposarcoma
RandomizedParallel-groupOpen-labelTreatment
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.
Timeline
- Start
- 2021-07-14
- Primary completion
- 2023-10-01
- Completion
- 2023-10-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Milademetan | Small molecule | 260 mg | Oral |
| Comparator | Trabectedin | Small molecule | 1.5 mg/m2 | Intravenous |