Nirogacestat in Ovarian Granulosa Cell Tumors
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| ClinicalTrials.gov Identifier: NCT05348356 |
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Recruitment Status :
Recruiting
First Posted : April 27, 2022
Last Update Posted : February 21, 2023
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Ovarian Granulosa-Stromal Tumor Ovarian Granulosa Cell Tumor Ovarian Cancer | Drug: Nirogacestat | Phase 2 |
Ovarian granulosa cell tumors (OvGCTs) represent 5-7% of all ovarian cancers (~1.5 to 2k newly diagnosed patients/year in the United States) and are the most common subtype of ovarian sex cord tumors (70%). Treatment of granulosa cell tumors with nirogacestat is expected to inhibit Notch-induced granulosa cell proliferation.
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. The participants will continue treatment until disease progression as determined by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 or unacceptable toxicity.
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 43 participants |
| Allocation: | N/A |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | A Phase 2 Trial of Nirogacestat in Patients With Recurrent Ovarian Granulosa Cell Tumors |
| Actual Study Start Date : | September 27, 2022 |
| Estimated Primary Completion Date : | July 2026 |
| Estimated Study Completion Date : | December 2027 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Nirogacestat Open-Label
All participants will receive open-label nirogacestat
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Drug: Nirogacestat
nirogacestat oral tablet
Other Name: PF-03084014 |
- Objective Response Rate (ORR) [ Time Frame: 2.5 years ]The proportion of participants with complete response (CR) + partial response (PR) assessed using RECIST v1.1 criteria.
- Progression Free Survival at 6 months (PFS-6) [ Time Frame: First day of cycle 7 (approximately 6 months after the first dose of study treatment). Each cycle is 28 days. ]The number of participants without progression according to RECIST v1.1 or death at 6 months.
- Overall Survival [ Time Frame: 2 years after first dose of study treatment ]The number of participants who have not died of any cause.
- Participant reported ovarian cancer symptoms [ Time Frame: At each study visit until study completion (estimated to be an average of 2.5 years) ]Change from baseline as measured by Functional Assessment of Cancer Therapy - Ovarian Symptom Index (FOSI).
- Duration of Response [ Time Frame: First day of every other cycle (each cycle is 28 days) for the first year, and then every 3 cycles thereafter until study completion (estimated to be an average of 2.5 years). ]The time from response (CR + PR using RECIST v.1.) to disease progression and/or death
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
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
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05348356
| Contact: SpringWorks Clinical | 919-790-1002 | clinical@springworkstx.com |
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| Responsible Party: | SpringWorks Therapeutics, Inc. |
| ClinicalTrials.gov Identifier: | NCT05348356 |
| Other Study ID Numbers: |
NIR-OGT-201 |
| First Posted: | April 27, 2022 Key Record Dates |
| Last Update Posted: | February 21, 2023 |
| Last Verified: | February 2023 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
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Neoplasms Granulosa Cell Tumor Ovarian Neoplasms Endocrine Gland Neoplasms Neoplasms by Site Ovarian Diseases Adnexal Diseases |
Genital Neoplasms, Female Urogenital Neoplasms Endocrine System Diseases Gonadal Disorders Sex Cord-Gonadal Stromal Tumors Neoplasms, Gonadal Tissue Neoplasms by Histologic Type |