Ignite Creation Date:
2025-12-18 @ 8:16 AM
Ignite Modification Date:
2025-12-18 @ 8:16 AM
Study NCT ID:
NCT06617923
Status:
None
Last Update Posted:
2025-10-27 00:00:00
First Post:
2024-09-19 00:00:00
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study of Senaparib in Combination With Temozolomide in ARID1A Mutation Associated Ovarian Cancer
Sponsor:
None
Organization:
Study Overview
Official Title:
A Phase 2 Study of Senaparib in Combination With Temozolomide in ARID1A Mutation Associated Ovarian Cancer
Status:
None
Status Verified Date:
2025-10
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 is a single-arm phase 2, two-stage, non-randomized multicenter Phase 2 study designed to evaluate the clinical activity (response frequency) of senaparib and temozolomide (TMZ) in patients with recurrent or persistent clear cell or endometrioid ovarian cancer.
Up to 18 adult female subjects will be enrolled and receive senaparib 80mg orally daily Days 1-28 and TMZ 20mg daily Days 1-21 of a 28 day cycle. Tumor assessments will be performed every 8 weeks for first 3 cycles then every 12 weeks thereafter until progressive disease is confirmed. Treatment will continue until either unacceptable toxicity, progression of disease, or withdrawal of consent.
Up to 18 adult female subjects will be enrolled and receive senaparib 80mg orally daily Days 1-28 and TMZ 20mg daily Days 1-21 of a 28 day cycle. Tumor assessments will be performed every 8 weeks for first 3 cycles then every 12 weeks thereafter until progressive disease is confirmed. Treatment will continue until either unacceptable toxicity, progression of disease, or withdrawal of consent.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: