Niraparib for Soft Tissue Sarcoma

Palo Alto (17 mi)

Overseen byEvan Rosenbaum, MD

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Memorial Sloan Kettering Cancer Center

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Approved in 3 jurisdictions

Trial Summary

What is the purpose of this trial?The purpose of this study is to test whether the study drug, niraparib, is effective against unresectable and/or metastatic soft tissue sarcoma with DDR mutations. The researchers will also study whether niraparib is safe and causes few or mild side effects, and whether there are groups of DDR mutations in soft tissue sarcoma cells that respond better to treatment with niraparib.

Eligibility Criteria

Adults with certain types of soft tissue or uterine sarcoma that can't be surgically removed and have spread, who've tried at least one other cancer treatment. They must have specific genetic changes in their tumor DNA related to the DDR pathway, measurable disease, good organ function, and a performance status indicating they can care for themselves. Women must not be pregnant and agree to contraception; men also need to use birth control.

Treatment Details

The trial is testing Niraparib's effectiveness on advanced soft tissue sarcomas with DDR mutations. It aims to find out if it's safe with mild side effects and if some genetic alterations respond better than others. Participants will receive Niraparib as the study drug.

1Treatment groups

Experimental Treatment

Group I: NiraparibExperimental Treatment1 Intervention

This study will utilize Simon's two-stage design: 16 patients will be enrolled in the first portion of this study. If 4 or more patients are progression-free at 12 weeks, an additional 16 patients will be enrolled for a total of n = 32 patients enrolled.

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

🇪🇺 Approved in European Union as Zejula for:

Maintenance treatment of adults with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete or partial) following completion of first-line platinum-based chemotherapy
Maintenance treatment of adults with platinum-sensitive relapsed high-grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete or partial) to platinum-based chemotherapy

🇺🇸 Approved in United States as Zejula for:

Maintenance treatment of adults with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in complete or partial response to platinum-based chemotherapy
Treatment of adults with advanced ovarian, fallopian tube, or primary peritoneal cancer treated with three or more prior chemotherapy regimens and whose cancer is associated with homologous recombination deficiency (HRD)-positive status

🇨🇦 Approved in Canada as Zejula for:

Maintenance treatment of adults with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in complete or partial response to platinum-based chemotherapy