Ignite Creation Date:
2024-05-06 @ 5:33 PM
Last Modification Date:
2024-10-26 @ 2:31 PM
Study NCT ID:
NCT05348356
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-11-22
First Post:
2022-04-13
Brief Title:
Nirogacestat in Ovarian Granulosa Cell Tumors
Sponsor:
SpringWorks Therapeutics Inc
Organization:
SpringWorks Therapeutics Inc
Study Overview
Official Title:
A Phase 2 Trial of Nirogacestat in Patients With Recurrent Ovarian Granulosa Cell Tumors
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2023-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This phase 2 clinical trial will study the effectiveness of nirogacestat in ovarian granulosa cell tumors OvGCTs Nirogacestat is a gamma secretase inhibitor GSI which is hypothesized to decrease the growth and activity of ovarian granulosa tumors
Detailed Description:
Ovarian granulosa cell tumors OvGCTs represent 5-7 of all ovarian cancers 15 to 2k newly diagnosed patientsyear 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 relapsedrefractory OvGCT The participants will continue treatment until disease progression as determined by Response Evaluation Criteria in Solid Tumors RECIST v11 unless the participants meet criteria for continued treatment or unacceptable toxicity
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 relapsedrefractory OvGCT The participants will continue treatment until disease progression as determined by Response Evaluation Criteria in Solid Tumors RECIST v11 unless the participants meet criteria for continued treatment or unacceptable toxicity
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None