A Randomized Multicenter Phase 3 Study of Milademetan Versus Trabectedin in Patients with Dedifferentiated Liposarcoma
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You are being invited to take part in a research study that includes studying an investigational drug called milademetan in unresectable or metastatic dedifferentiated liposarcoma. Investigational means it has not yet been approved for marketing by any authority that regulates new medicines. The purpose of this study is to learn about the safety, tolerability and effectiveness of an investigational drug called milademetan as compared to the use of trabectidin. In this study, subjects will be randomly assigned (like flipping a coin) to receive one of two study drugs: milademetan or trabectedin. This is an open- label study, meaning you will know which study drug you are assigned to receive. The total duration of study participation will vary by subject and is not known in advance. If you join this study, you could take part in a Screening Period, several 28-day (for milademetan) or 21-day (for trabectedin) treatment cycles, an End of Treatment Visit, and several follow-up visits after you stop treatment.
Are you Eligible? (Inclusion Criteria)
- Are you 18 years of age or older?
- Do you have an ECOG performance status of 0 or 1?
- Are you willing to provide an archival tumor tissue sample that is ≤ 3 years old and of adequate quality or willing to provide a fresh pretreatment biopsy sample?
