Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06617923
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-19
Brief Title:
Study of Senaparib in Combination With Temozolomide
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Phase 2 Study of Senaparib in Combination With Temozolomide in ARID1A Mutation Associated Ovarian Cancer
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a study to test the effectiveness anti-tumor activity of the combination of the study drugs Senaparib and Temozolomide
Detailed Description:
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
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?:
None