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Preoperative Olaparib Endometrial Carcinoma Study (POLEN)

NCT02506816 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 36

Last updated 2020-11-30

Study results available
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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.

Conditions

  • Endometrial Carcinoma

Interventions

DRUG

Olaparib

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

Sponsors & Collaborators

  • AstraZeneca

    collaborator INDUSTRY

  • Experior

    collaborator INDUSTRY

  • MedSIR

    lead OTHER

Principal Investigators

  • Antonio Llombart, MD, PhD · Medica SIR

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-02-29
Primary Completion
2018-07-31
Completion
2019-03-31

Countries

  • Spain

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02506816 on ClinicalTrials.gov