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metastatic endometrial cancer
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
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.
Placebo oral capsule,
Olaparib Oral Capsule
Clinical Study Identifier
ARCAGY/ GINECO GROUP
Last Modified on
9 September 2020
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
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