Circulating Tumor DNA Guiding (Olaparib) Lynparza® Treatment in Ovarian Cancer (CLIO)

January 26, 2021 updated by: Universitaire Ziekenhuizen KU Leuven

Circulating Tumor DNA Guiding (Olaparib) Lynparza® Treatment in Ovarian

This is a randomized, open-label, two-arm study in patients with relapsed epithelial ovarian tumors. Patients will be randomized in a 1:1 ratio to receive olaparib or standard chemotherapy with the possibility of crossover at the time of progression.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

160

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • with recurrent epithelial carcinoma of the ovary, fallopian tube or primary peritoneum
  • At least 1 previous line of chemotherapy
  • Measurable disease
  • Patients have a normal organ and bone marrow function measured within 28 days of randomization
  • WHO 0-2

Exclusion Criteria:

  • Primary platinum-refractory disease
  • Known hypersensitivity to olaparib
  • Resting ECG with QTc > 470 msec
  • Concomitant use of known potent CYP3A4 inhibitors
  • Symptomatic uncontrolled brain metastases
  • Patients unable to swallow orally administered medication and patients with gastrointestinal disorders likely to interfere with absorption of the study medication

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Olaparib
olaparib 300mg oral tablets twice daily for 28 days in 28-day cycles
Drug: Olaparib
Other Names:
  • Lynparza
Active Comparator: Chemotherapy
physician's choice chemotherapy
Drug: carboplatin + gemcitabine or carboplatin + paclitaxel or carboplatin + liposomal doxorubicin or liposomal doxorubicin 4-weekly or topotecan or paclitaxel weekly
physician's choice chemotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Overall Objective Response
Time Frame: 1 year after end inclusion
1 year after end inclusion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universitaire Ziekenhuizen KU Leuven

Collaborators

AstraZeneca

Investigators

  • Principal Investigator: Ignace Vergote, Universitaire Ziekenhuizen KU Leuven

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2016

Primary Completion (Anticipated)

July 1, 2021

Study Completion (Anticipated)

July 1, 2023

Study Registration Dates

First Submitted

June 6, 2016

First Submitted That Met QC Criteria

June 29, 2016

First Posted (Estimate)

July 4, 2016

Study Record Updates

Last Update Posted (Actual)

January 29, 2021

Last Update Submitted That Met QC Criteria

January 26, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CLIO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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