At a glance
ClinicalIndex Comparison RecordN/ACompleted· 36 enrolled
Drug / intervention
Olaparibdrug
Likely dose
Olaparib 600mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Preoperative "Window-opportunity", Multicenter, Pharmacokinetic-pharmacodynamic Study to Evaluate the Inhibitory Effects of Single Agent AZD2281 (Olaparib), in Patients With Early-stage Endometrial Carcinoma
In Brief
An observational study evaluating Olaparib for Endometrial Carcinoma. Completed, enrolled 36 participants across 10 sites.
Detailed Summary
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.
Study Details
Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsEndometrial Carcinoma
CountriesSpain
CollaboratorsAstraZeneca, Experior
Timeline
N/ACompletedFinished
20162017201820192020202120222023202420252026
First PostedJul 2015
Enrollment StartFeb 2016
Primary CompletionJul 2018
Study CompletionMar 2019
TodayJul 2026
First PostedJul 23, 2015
Enrollment StartFeb 1, 2016
Primary CompletionJul 1, 2018
Study CompletionMar 1, 2019
TodayJul 2, 2026
Enrollment to primary: 2.4 yearsPosted 10.9 years ago
Interventions
Olaparibdrug
Drug exposure has a limited duration 28 (+/- 5) days and at lower dose (600mg/day) than therapeutical accepted (800mg/day).