Preoperative Olaparib Endometrial Carcinoma Study (POLEN)

Sponsor
MedSIR
Study ID
NCT02506816
Status
Completed

Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 90 Years
Healthy Volunteers
Not accepted

Interventions

  • Olaparib — DRUG
    Drug exposure has a limited duration 28 (+/- 5) days and at lower dose (600mg/day) than therapeutical accepted (800mg/day).

Study Details

The primary objective of this study is to identify, in human tumour samples, biomarker changes associated to short exposure to AZD2281 as potential predictors of activity in Endometrial Carcinoma (EC). This is an exploratory study with a biological primary endpoint. Clinical efficacy or safety are not a primary objective of the study.

Key Dates

Start date
Feb 29, 2016
Status verified
Nov 2019
Primary completion
Jul 31, 2018
Completion
Mar 31, 2019

Study Design

Enrollment
36 participants (actual)

Arms

  • Arm: Olaparib
    Drug exposure has a limited duration 28 (+/- 5) days.

Primary Outcome Measure

Expression of Cell Cycle-related Proteins [ Time Frame: Baseline and Day 28 (+/- 5) ]

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