Niraparib + Copanlisib for Gynecologic Cancers

Recruiting in Palo Alto (17 mi)

Overseen ByShannon Westin, MD

Age: 18+

Sex: Female

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: M.D. Anderson Cancer Center

No Placebo Group

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?This phase Ib trial studies the best dose and side effects of niraparib and copanlisib in treating patients with endometrial, ovarian, primary peritoneal, or fallopian tube cancer that has come back. Niraparib and copanlisib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Eligibility Criteria

This trial is for patients with recurrent endometrial, ovarian, primary peritoneal, or fallopian tube cancer. Participants must have had any number of prior chemotherapies and a life expectancy of at least 3 months. They should be able to perform daily activities with little assistance (ECOG status 0-1), not be pregnant, use effective contraception, and meet certain health criteria.

Participant Groups

The trial is testing the combination of two drugs: Niraparib and Copanlisib. It aims to find the best dose while observing side effects in patients whose cancer has returned. These drugs are believed to block enzymes that tumor cells need for growth.

1Treatment groups

Experimental Treatment

Group I: Treatment (niraparib, copanlisib)Experimental Treatment2 Interventions

Patients receive niraparib PO daily on days 1-28 and copanlisib IV on days 1, 8, and 15. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.