UTOLA: UTerin OLAparib — UTOLA  

Endometrial Carcinoma Clinical Trial

Official title: Multicenter Double Blind Randomized Phase II Trial of Olaparib vs Placebo as Maintenance Therapy in Platinum-sensitive Advanced Endometrial Carcinoma

Status Active, not recruiting

Clinical Trial 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

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Carcinoma
• Endometrial Carcinoma
• Endometrial Neoplasms

• NCT number: NCT03745950
• Study type: Interventional
• Source: ARCAGY/ GINECO GROUP
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: February 1, 2019
• Completion date: December 2024