Ignite Creation Date:
2024-07-17 @ 11:59 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06463028
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-17
First Post:
2024-06-11
Brief Title:
Sapanisertib and Serabelisib PIKTOR With Paclitaxel Serabelisib With Paclitaxel and Paclitaxel Alone in Patients With AdvancedRecurrent Endometrial Cancer
Sponsor:
Faeth Therapeutics
Organization:
Faeth Therapeutics
Study Overview
Official Title:
A Randomized Open-label Multi-Center Phase 2 Clinical Trial Evaluating Sapanisertib and Serabelisib PIKTOR With Paclitaxel Serabelisib With Paclitaxel and Paclitaxel Alone in Patients With Advanced or Recurrent Endometrial Cancer
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
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 Phase 2 multicenter open-label randomized study to evaluate the efficacy and safety of sapanisertib and serabelisib PIKTOR with paclitaxel and the efficacy and safety of serabelisib with paclitaxel versus paclitaxel alone in participants with advanced or recurrent endometrial cancer
Detailed Description:
This is a Phase 2 multicenter open-label randomized study to evaluate the efficacy and safety of sapanisertib and serabelisib PIKTOR with paclitaxel and the efficacy and safety of serabelisib with paclitaxel versus paclitaxel alone in participants with advanced or recurrent endometrial cancer who have failed prior systemic therapies including a platinum-based therapy and an immune checkpoint inhibitor either separately or together
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| GOG-3111 | OTHER | None | None |