Trials / Completed
CompletedNCT03745950
UTOLA: UTerin OLAparib
Multicenter Double Blind Randomized Phase II Trial of Olaparib vs Placebo as Maintenance Therapy in Platinum-sensitive Advanced Endometrial Carcinoma
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 147 (actual)
- Sponsor
- ARCAGY/ GINECO GROUP · Academic / Other
- Sex
- Female
- Age
- 18 Years – 95 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Olaparib Oral Capsule | \- Olaparib will be administrated by oral at dose of 300 mg twice daily during the induction period and in maintenance |
| DRUG | Placebo oral capsule | \- Placebo will be administrated by oral at dose of 300 mg twice daily during the induction period and in maintenance |
Timeline
- Start date
- 2019-02-01
- Primary completion
- 2023-05-22
- Completion
- 2024-09-24
- First posted
- 2018-11-19
- Last updated
- 2024-12-04
Locations
36 sites across 1 country: France
Source: ClinicalTrials.gov record NCT03745950. Inclusion in this directory is not an endorsement.