Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 4:46 PM
Ignite Modification Date:
2025-12-24 @ 4:46 PM
NCT ID:
NCT03745950
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.
Study:
NCT03745950
Study Brief:
Protocol Section:
NCT03745950