Ribociclib + Everolimus for Dedifferentiated Liposarcoma and Leiomyosarcoma

Recruiting in Palo Alto (17 mi)

+1 other location

Overseen by Margaret von Mehren, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Fox Chase Cancer Center

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

This trial tests a combination of two drugs, Ribociclib and Everolimus, in patients with advanced DDL and LMS who have not responded to previous treatments. Ribociclib blocks proteins that help cancer grow, while Everolimus stops cancer cells from multiplying. Everolimus is an oral mTOR inhibitor that is approved for various cancers, including renal cell carcinoma and breast cancer.

Eligibility Criteria

Adults with advanced dedifferentiated liposarcoma (DDL) or leiomyosarcoma (LMS) who've had at least one prior systemic therapy can join this trial. They should be in good physical condition, able to take oral medication, and have measurable disease progression after their last treatment. Women must not be pregnant or nursing, and all participants must agree to use effective contraception.

Inclusion Criteria

My cancer is a type of sarcoma that has spread or is not responding to treatment.

My blood tests show my organs and bone marrow are working well.

I am 18 years old or older.

Exclusion Criteria

I have a stomach or intestine problem that affects how I absorb medicine.

Patient has any other concurrent severe and/or uncontrolled medical condition

I do not have uncontrolled heart disease or abnormal heart rhythms.

Participant Groups

The study is testing a combination of two drugs: Ribociclib taken orally for three weeks with a one-week break, and Everolimus taken continuously every day. The goal is to see how well these drugs work together against DDL and LMS by monitoring tumor response using scans at specific intervals.

Group I: Leiomyosarcoma Arm Experimental Treatment 2 Interventions

Patients receive ribociclib orally at 300mg/day for 21 days of each 28 day cycle and everolimus 2.5mg orally on a continuous 28 day cycle.

Group II: Dedifferentiated Liposarcoma Arm Experimental Treatment 2 Interventions

Patients receive ribociclib orally at 300mg/day for 21 days of each 28 day cycle and everolimus 2.5mg orally on a continuous 28 day cycle.

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

🇺🇸 Approved in United States as Afinitor for:

• Advanced renal cell carcinoma
• Subependymal giant cell astrocytoma
• Progressive neuroendocrine tumors of pancreatic origin
• Advanced hormone receptor-positive, HER2-negative breast cancer
• Tuberous sclerosis complex-associated partial-onset seizures

🇪🇺 Approved in European Union as Votubia for:

• Subependymal giant cell astrocytoma
• Renal angiomyolipoma
• Tuberous sclerosis complex-associated partial-onset seizures

🇺🇸 Approved in United States as Zortress for:

• Prevention of organ rejection in kidney transplant patients

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Dana-Farber Cancer Institute Boston, MA

Fox Chase Cancer Center Philadelphia, PA

Who Is Running the Clinical Trial?

Fox Chase Cancer Center Lead Sponsor

References