Nirogacestat for Ovarian Cancer

Recruiting at 47 trial locations

Overseen By SpringWorks Clinical

Age: 18+

Sex: Female

Trial Phase: Phase 2

Sponsor: SpringWorks Therapeutics, Inc.

Must not be taking: Bevacizumab, Monoclonal antibodies

Disqualifiers: Bowel obstruction, Cardiac event, Liver disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Breakthrough Therapy This drug has been fast-tracked for approval by the FDA given its high promise

Compensation: Varies

Number of Visits: Unknown

Duration: Up to 2.5 years

53 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial requires that you stop taking certain treatments for ovarian granulosa cell tumors, such as hormonal therapy, chemotherapy, immunotherapy, targeted therapy, or any investigational treatment, at least 28 days before starting the study treatment.

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.

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.

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.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive open-label nirogacestat until disease progression or unacceptable toxicity

Up to 2.5 years

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

Treatment Details

Interventions

• Nirogacestat

Trial Overview The 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

Group I: Nirogacestat Open-Label Experimental Treatment 1 Intervention

All participants will receive open-label nirogacestat

Who Is Running the Clinical Trial?

SpringWorks Therapeutics, Inc.

Lead Sponsor

Trials

14

Recruited

900+