Abemaciclib for Liposarcoma

Recruiting in Palo Alto (17 mi)

+9 other locations

Overseen byMark Dickson, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Sarcoma Alliance for Research through Collaboration

Pivotal Trial (Near Approval)

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?This trial is testing abemaciclib, a drug that blocks proteins helping cancer cells grow, in patients with advanced or spreading DDLS. The goal is to see if it can stop the cancer from getting worse.

Eligibility Criteria

Adults with advanced dedifferentiated liposarcoma, measurable disease progression, and an ECOG Performance Status of 0 or 1 can join. They must be able to swallow pills, have recovered from prior treatments, and use effective birth control. Excluded are those who need urgent chemotherapy, have had certain recent surgeries or therapies including CDK4 inhibitors like abemaciclib, severe concurrent diseases, resectable disease for cure intent, pregnancy/breastfeeding women, known hypersensitivity to abemaciclib or untreated central nervous system disease.

Inclusion Criteria

I can take pills by mouth.

If you're a woman of childbearing age, you must use a very effective form of birth control like an IUD or barrier method. If you choose condoms, you should also use a sperm-killing gel or cream for extra protection.

My cancer has grown or spread recently.

+10 more

Exclusion Criteria

I do not have any stomach or intestine problems that affect how I absorb pills.

I do not have a slow-growing type of liposarcoma.

I have a history of serious heart conditions, including fainting due to heart issues, dangerous irregular heartbeats, or sudden cardiac arrest.

+14 more

Participant Groups

This Phase 3 trial tests the drug Abemaciclib against a placebo in patients with advanced dedifferentiated liposarcoma. If their condition worsens on placebo they can switch to open-label Abemaciclib. The study is double-blind meaning neither participants nor researchers know who gets the real drug versus placebo until after the results.

2Treatment groups

Experimental Treatment

Placebo Group

Group I: AbemaciclibExperimental Treatment1 Intervention

Abemaciclib will be administered 200mg orally twice a day. Each cycle is 28 days.

Group II: Placebo ArmPlacebo Group1 Intervention

Patients will be randomized 1:1 and will receive placebo if they are randomized to the placebo arm of the study. Each cycle is 28 days.

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: