What side effects are associated with this type of intervention?

Common treatments for Ovarian Granulosa Cell Tumor (OvGCT) include surgery, chemotherapy, and hormone therapy. For treatments similar to Nirogacestat, a Gamma Secretase Inhibitor (GSI), known side effects may include gastrointestinal issues (such as nausea and diarrhea), fatigue, and potential liver toxicity. Additionally, GSIs can cause skin reactions and hematologic abnormalities. It is important for patients to discuss these potential side effects with their healthcare provider to manage and mitigate them effectively.

What prior FDA approvals exist?

There are no specific FDA-approved treatments for Ovarian Granulosa Cell Tumor (OvGCT) that are similar to Nirogacestat, a Gamma Secretase Inhibitor. Treatment for OvGCT typically involves surgery and may include chemotherapy or radiation, but targeted therapies like GSIs are still under investigation. Nirogacestat is currently being studied in a phase 2 clinical trial for its potential to inhibit tumor growth in OvGCT.

What other types of research exist?

Promising novel alternatives to Nirogacestat for ovarian granulosa cell tumor patients in 2024 include: 1) Inhibitors targeting the Hedgehog signaling pathway, such as Taladegib, which has shown efficacy in preclinical models. 2) BCL2 inhibitors like Venetoclax, which have been effective in other myeloid malignancies and could be explored for granulosa cell tumors. 3) Combination therapies involving epigenetic modulators like Azacitidine and Lenalidomide, which have shown promise in high-risk myelodysplastic syndromes and could be repurposed for granulosa cell tumors.

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Gamma Secretase Inhibitor

Nirogacestat for Ovarian Cancer

Phase 2

Waitlist Available

Research Sponsored by SpringWorks Therapeutics, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Has histologically confirmed recurrent adult-type granulosa cell tumor of the ovary prior to first dose of study treatment

Have documented radiological evidence of relapse after at least one systemic therapy that is not amenable to surgery, or radiation and have measurable disease by RECIST v1.1 criteria

Must not have

Has signs of bowel obstruction requiring parenteral nutrition, malabsorption syndrome or preexisting gastrointestinal conditions that may impair absorption of nirogacestat

Has current or chronic history of liver disease or known hepatic or biliary abnormalities

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2.5 years

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects may include issues related to bowel function due to absorption concerns, risks associated with heart health such as abnormal heartbeat rhythms, and possibly liver-related complications.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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

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

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I have not had bevacizumab or similar treatments for my cancer in the last 28 days.

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I have not had a major heart event or blood clot in the last 6 months.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2.5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2.5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2.5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Objective Response Rate (ORR)

Secondary study objectives

Duration of Response

Overall Survival

Participant reported ovarian cancer symptoms

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Nirogacestat Open-LabelExperimental Treatment1 Intervention

All participants will receive open-label nirogacestat

0 / 7Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Ovarian Granulosa Cell Tumor (OvGCT) include surgery, chemotherapy, and hormone therapy. Gamma Secretase Inhibitors (GSIs) like Nirogacestat work by inhibiting the gamma secretase enzyme, which is involved in the Notch signaling pathway. This pathway is crucial for cell differentiation and proliferation. By inhibiting gamma secretase, GSIs can reduce tumor growth and activity. Understanding these mechanisms is vital for OvGCT patients as it helps in selecting targeted therapies that can effectively manage the tumor with potentially fewer side effects compared to conventional treatments.

Emerging biomarkers in ovarian granulosa cell tumors.