Olaparib + Temozolomide for Leiomyosarcoma

Recruiting at 15 trial locations

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: National Cancer Institute (NCI)

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This trial is testing olaparib and temozolomide in patients with advanced uterine leiomyosarcoma. Olaparib stops cancer cells from repairing themselves, while temozolomide kills or stops the growth of cancer cells. The combination may be more effective than using either drug alone.

Research Team

Brian Van Tine

Principal Investigator

Yale University Cancer Center LAO

Eligibility Criteria

Adults with advanced uterine leiomyosarcoma that's spread or can't be surgically removed, who've had prior treatment failure or intolerance. Must be able to swallow pills, have adequate organ function, use effective contraception if needed, and agree to study procedures.

Inclusion Criteria

AST/ALT =< 2.5 x institutional ULN

I am 18 years old or older.

Total bilirubin =< 1.5 x institutional upper limit of normal (ULN)

Exclusion Criteria

I am allergic to medications similar to olaparib or TMZ.

Involvement in the planning and/or conduct of the study

You are either pregnant or breastfeeding.

Treatment Details

Interventions

• Olaparib (PARP Inhibitor)
• Temozolomide (Alkylating Agent)

Trial Overview The trial tests a combination of Olaparib (a PARP inhibitor preventing tumor DNA repair) and Temozolomide (chemotherapy), aiming to see if they're more effective together against this cancer than when used separately.

Participant Groups

Group I: Treatment (olaparib, temozolomide) Experimental Treatment 5 Interventions

Patients receive olaparib PO BID and temozolomide PO QD on days 1-7 of each cycle. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients undergo CT or MRI throughout the trial and undergo tumor biopsy at screening and on study.

Who Is Running the Clinical Trial?

National Cancer Institute (NCI)

Lead Sponsor

Trials

14,080

Recruited

41,180,000+