A Phase III Study of Abemaciclib Compared to Placebo in People with Dedifferentiated Liposarcoma

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Full Title

Phase 3 Randomized Double-Blind Study of Abemaciclib versus Placebo in Patients with Advanced Dedifferentiated Liposarcoma

Purpose

The purpose of this study is to compare the effectiveness of the drug abemaciclib with a placebo (inactive drug) to treat advanced dedifferentiated liposarcoma. Abemaciclib blocks a family of proteins called CDKs which promote cancer cell growth. By blocking these proteins, abemaciclib may prevent cancer cells from growing, and the cancer may stop spreading or may shrink.

Participants in this study will be randomly assigned to receive abemaciclib or a placebo. Abemaciclib is already used to treat some types of breast cancer; its use in this study is considered investigational. It is taken orally (by mouth).

Eligibility

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

  • Patients must have advanced dedifferentiated liposarcoma that is continuing to grow.
  • At least 2 weeks must pass since the completion of prior radiation therapy and 3 weeks since chemotherapy and receipt of the study treatment.
  • 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 and to ask about eligibility for this study, please contact the office of Dr. Mark Dickson at 646-888-4164.

Protocol

21-520

Phase

III

Disease Status

Newly Diagnosed & Relapsed/Refractory

Investigator

Co-Investigators