A Phase III Study of Milademetan versus Trabectedin in Patients with Dedifferentiated Liposarcoma

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Full Title

A Randomized Multicenter Phase 3 Study of Milademetan Versus Trabectedin in Patients with Dedifferentiated Liposarcoma (WIRB)

Purpose

The purpose of this study is to compare the effectiveness of the investigational drug milademetan with the standard treatment trabectedin in people with inoperable or metastatic dedifferentiated liposarcoma that continues to grow despite prior treatment. Milademetan inhibits a protein called MDM2 that may promote cancer growth. Trabectedin has already been approved to treat patients with liposarcoma that came back or continued to grow after initial therapy.

Participants in this study will be randomly assigned to receive either milademetan or trabectedin. Milademetan is taken orally (by mouth) and trabectedin is given intravenously (by vein).

Eligibility

To be eligible for this study, patients must meet several requirements, including:

  • Participants must have inoperable or metastatic dedifferentiated liposarcoma that continues to grow despite prior treatment.
  • The serious side effects of previous therapies must get better before the study treatment is given.
  • Patients must be physically well enough that they are able to be mobile, take care of themselves, and engage in all but physically strenuous activities. For example, they must be well enough that they could carry out office work or light housework.
  • This study is for people age 18 and older.

For more information about this study and to ask about eligibility, please contact the office of Dr. Mrinal Gounder at 646-888-4167.

Protocol

21-496

Phase

III

Disease Status

Newly Diagnosed & Relapsed/Refractory

Investigator

Co-Investigators