Trabectedin + Olaparib for Sarcoma

Recruiting in Palo Alto (17 mi)

Overseen ByRashmi Chugh, M.D.

Age: Any Age

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: University of Michigan Rogel Cancer Center

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?This phase II trial studies how well trabectedin and olaparib work in treating patients with sarcoma that cannot be removed by surgery or has spread to other places in the body. Drugs used in chemotherapy, such as trabectedin, work in different ways to stop the growth of tumor cells, either by killing cells, stopping them from dividing or stopping them from spreading. Olaparib may stop the growth of tumor cells by blocking pathways responsible for repairing damaged cells. Giving trabectedin and olaparib may shrink or stop the tumor from growing.

Eligibility Criteria

This trial is for adults and teens (16+) with advanced sarcoma that can't be surgically removed or has spread. Participants must have tried at least one chemotherapy, which for certain sarcomas includes an anthracycline. They need to have measurable disease, good heart function, and normal blood, kidney, and liver tests. Women who can bear children and men must use birth control during the study.

Inclusion Criteria

I am 16 years old or older.

My sarcoma cannot be removed by surgery and has spread.

I am fully active and can carry on all my pre-disease activities without restriction.

I have been diagnosed with Leiomyosarcoma or Liposarcoma.

I have had at least one standard chemotherapy, including an anthracycline for cohort 1.

Exclusion Criteria

I have been treated with trabectedin before.

I am allergic to trabectedin or olaparib.

I have previously been treated with a PARP inhibitor like olaparib.

Participant Groups

The trial is testing a combination of two drugs: Trabectedin (a chemotherapy drug) and Olaparib (blocks cell repair), to see if they work together to stop tumor growth in patients with advanced sarcoma. It's a phase II study designed to assess how well these tumors respond when both drugs are given.

1Treatment groups

Experimental Treatment

Group I: Olaparib + TrabectedinExperimental Treatment2 Interventions

There are 2 cohorts. Both cohorts receive the same treatment: * Cohort 1: Leiomyosarcoma and liposarcoma * Cohort 2: Other bone or soft tissue sarcoma histologies Treatment consists of 21-day cycles for a maximum of 18 months.

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

🇪🇺 Approved in European Union as Lynparza for: