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Clinical Trial 21870

Cancer Type: Gynecological Tumor
Study Type: Treatment
NCT#: NCT05348356

Phase: Phase II
Principal Investigator: Wenham, Robert

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Overview

Study Title

A Phase 2 trial of Nirogacestat in Patients with Recurrent Ovarian Granulosa Cell Tumors

Summary

This is a multi-center, single-arm, Phase 2 open label treatment study to determine the efficacy, safety, tolerability, and pharmacokinetics of nirogacestat in adult participants with relapsed/refractory OvGCT.

Objective

Primary Objectives: To determine the anti-tumor activity of nirogacestat in adult participants with relapsed/refractory OvGCT. Secondary Objectives: To determine if nirogacestat delays progression or death in OvGCT. To describe overall survival in participants treated with nirogacestat. To determine the effect of nirogacestat on ovarian cancer symptoms measured by Functional Assessment of Cancer Therapy Ovarian Symptom Index (FOSI). To determine the duration of response. To determine the pharmacokinetics (PK) of nirogacestat.

Treatments

Therapies

Therapy (NOS)

Medications

Nirogacestat ()

Inclusion Criteria

Key Inclusion Criteria:

  • 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
  • Have adequate bone marrow, renal and hepatic function as defined by screening visit laboratory values
  • Other criteria apply

  • Exclusion Criteria

    Key Exclusion Criteria:

  • Has signs of bowel obstruction requiring parental nutrition, malabsorption syndrome or preexisting gastrointestinal conditions that may impair absorption of nirogacestat
  • Has had a major cardio or thrombo-embolic event within 6 months of signing informed consent
  • Has abnormal QT interval at Screening, or has congenital or acquired long QT syndrome or a history of additional risk factors for Torsades de Pointes
  • Has current or chronic history of liver disease or known hepatic or biliary abnormalities
  • Has received any treatment for OvGCT including but not limited to the following within 28 days (or 5 half-lives, whichever is longer) prior to the first dose of study treatment: anti-angiogenic therapy, hormonal therapy, chemotherapy, immunotherapy, targeted therapy or any investigational treatment
  • Additional criteria apply

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