Abemaciclib for Liposarcoma

Palo Alto (17 mi)

Overseen byMark Dickson, MD

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Memorial Sloan Kettering Cancer Center

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Approved in 2 jurisdictions

Trial Summary

What is the purpose of this trial?The purpose of this study is to test any good and bad effects of the study drug called Abemaciclib. Abemaciclib could shrink your cancer but it could also cause side effects. Researchers hope to learn if the study drug will delay the growth of the cancer or shrink the cancer by at least one quarter compared to its present size. Abemaciclib is not FDA approved and has not been tested in liposarcoma, but it has shrunk tumors in patients with breast cancer, lymphoma, and lung cancer.

Eligibility Criteria

This trial is for adults with a specific cancer called dedifferentiated liposarcoma, confirmed at MSKCC. Participants must have measurable disease progression recently and can have had any number of prior treatments, but not within the last 2-4 weeks (6 weeks for certain drugs). They should be in good physical condition (ECOG 0 or 1), not have other active cancers, and agree to use contraception. Those with stable treated brain metastasis may join.

Inclusion Criteria

I am fully active or can carry out light work.

I agree to use birth control and will not breastfeed while in the study.

My dedifferentiated liposarcoma was confirmed at MSKCC.

My cancer has spread and cannot be removed with surgery.

My organs and bone marrow are working well.

I do not have any other cancer that needs treatment.

I am 18 years old or older.

Exclusion Criteria

I have recovered from previous treatment side effects to a mild level.

I have been treated with a CDK4 inhibitor before.

I do not have any severe illnesses or infections that would interfere with the study.

Treatment Details

The study is testing Abemaciclib's effects on dedifferentiated liposarcoma. The drug has shown promise in shrinking tumors in breast cancer, lymphoma, and lung cancer patients but isn't FDA approved for liposarcoma yet. Researchers want to see if it can delay tumor growth or shrink tumors by at least one quarter.

1Treatment groups

Experimental Treatment

Group I: Abemaciclib (LY2835219)Experimental Treatment1 Intervention

Patients will be treated with abemaciclib 200 mg bid.

Abemaciclib is already approved in United States, European Union for the following indications:

🇺🇸 Approved in United States as Verzenio for:

Hormone receptor-positive (HR+), human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer
HR+, HER2- node-positive early breast cancer

🇪🇺 Approved in European Union as Verzenio for: