Nirogacestat for Ovarian Cancer

Recruiting in Palo Alto (17 mi)

+47 other locations

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: SpringWorks Therapeutics, Inc.

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

This trial studies nirogacestat, a drug that blocks a protein to slow down tumor growth, in adult patients with ovarian granulosa cell tumors that have come back or did not respond to previous treatments. Nirogacestat is being tested in combination with other agents for certain types of cancer.

Research Team

Eligibility Criteria

This trial is for adults with recurrent ovarian granulosa cell tumors who've had at least one systemic therapy and can't have surgery or radiation. They must have measurable tumor growth, no major heart events or abnormal QT intervals recently, and not be on certain treatments like monoclonal antibodies within the last 28 days.

Inclusion Criteria

My ovarian cancer is a confirmed adult-type granulosa cell tumor.

My cancer returned after treatment and can't be removed by surgery or treated with radiation, but it can be measured.

My blood, kidney, and liver tests are within normal ranges.

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Exclusion Criteria

I have a bowel blockage or a condition that affects how my body absorbs medication.

I have a history of liver disease or liver/bile duct issues.

I have not had treatments like chemotherapy for my ovarian germ cell tumor in the last 28 days.

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Treatment Details

Interventions

Nirogacestat (Gamma Secretase Inhibitor)

Trial OverviewThe trial is testing Nirogacestat, a drug thought to slow down the growth of ovarian granulosa cell tumors. It's a phase 2 study which means it focuses on the effectiveness of this treatment for patients who meet specific criteria.

Participant Groups

1Treatment groups

Experimental Treatment

Group I: Nirogacestat Open-LabelExperimental Treatment1 Intervention

All participants will receive open-label nirogacestat