Ignite Creation Date:
2025-12-24 @ 4:46 PM
Ignite Modification Date:
2026-01-05 @ 9:29 AM
Study NCT ID:
NCT03745950
Status:
COMPLETED
Last Update Posted:
2024-12-04
First Post:
2018-10-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
UTOLA: UTerin OLAparib
Sponsor:
ARCAGY/ GINECO GROUP
Organization:
Study Overview
Official Title:
Multicenter Double Blind Randomized Phase II Trial of Olaparib vs Placebo as Maintenance Therapy in Platinum-sensitive Advanced Endometrial Carcinoma
Status:
COMPLETED
Status Verified Date:
2024-12
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:
UTOLA
Brief Summary:
This is a phase IIB, national, randomized, double-blinded, comparative, multi-center study, to assess the efficacy of Olaparib as maintenance after a platinum based chemotherapy in patients with Advanced or metastatic endometrial cancer
Detailed Description:
Approximately 147 patients will be randomized using an Interactive Voice Response System / Interactive web system (IVR/IWR system) in a 2:1 ratio to the treatments as specified below :
* Olaparib tablets per os 300 mg twice daily,
* Placebo tablets per os 300 mg twice daily.
Before randomization to the study :
* Patient should be without evidence of disease (NED), or in clinical complete response or in partial response or stable.
* Patient must have completed a minimum of 4 cycles of first line platinum based chemotherapy (recommended chemotherapy is carboplatine AUC 5 plus paclitaxel 175 mg/m2).
Patient will be stratified according to :
* P53 and MMR Immunohistochemistry, (Y/N)
* Response to previous chemotherapy line (Objective response versus Stable)
Patients will receive Olaparib/Placebo up to disease progression.
* Olaparib tablets per os 300 mg twice daily,
* Placebo tablets per os 300 mg twice daily.
Before randomization to the study :
* Patient should be without evidence of disease (NED), or in clinical complete response or in partial response or stable.
* Patient must have completed a minimum of 4 cycles of first line platinum based chemotherapy (recommended chemotherapy is carboplatine AUC 5 plus paclitaxel 175 mg/m2).
Patient will be stratified according to :
* P53 and MMR Immunohistochemistry, (Y/N)
* Response to previous chemotherapy line (Objective response versus Stable)
Patients will receive Olaparib/Placebo up to disease progression.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
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?: