A Study of Long-Term Responders on Olaparib (OLALA)

January 8, 2023 updated by: University Health Network, Toronto

A Retrospective/Prospective Analysis of Characterization of the Long-Term Responders on Olaparib in Solid Tumours

This is an observational and sample collection study involving patients (alive or deceased) from several clinical trials who had received the investigational drug, olaparib in other research studies. There is no intervention given for this study.

This research is being done to understand of the mechanisms involved in patients whose cancer responds well and whose cancer does not respond well to investigational drug, olaparib, to help better understand how olaparib works and to better identify patients who may benefit from this therapy.

Study Overview

Status

Completed

Conditions

Detailed Description

This is study will compare biomarker research with response in patients who have received olaparib.

Patients who have had a durable response to olaparib for at least 2 years will be approached for the study.

Patients who agree to this study will then have their medical history collected and will be asked to complete a questionnaire. Archival tumor tissue will also be collected for biomarker research.

A waiver of consent is requested to access the medical records and archival tumor tissue of patients who are deceased.

If participants are still taking olaparib, they will be asked to provide blood samples for pharmacokinetics and circulating tumor DNA, and the results of CT scans taken as part of their standard of care or as a part of another research study. If participants' disease worsens while still on olaparib, they will then be asked to provide a blood sample for pharmacogenomics and BRCA testing (if not known). An optional tumor biopsy will also be requested.

Participants will continue to be followed by telephone for survival and any new treatments they are receiving.

Study Type

Observational

Enrollment (Actual)

118

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

  • Australia
    • New South Wales
      • Randwick, New South Wales, Australia, 2031
        • South Eastern Sydney Local Health District
  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 4E6
        • British Columbia Cancer Centre
    • Ontario
      • Ottawa, Ontario, Canada
        • Ottawa Hospital Research Institute
      • Toronto, Ontario, Canada, M5G 2M9
        • Princess Margaret Cancer Centre
  • Italy
      • Milan, Italy
        • Institute of European Oncology
  • Spain
      • Barcelona, Spain
        • Vall d'Hebron
  • United Kingdom
    • England
      • Sutton, England, United Kingdom, SM2 5PT
        • The Royal Marsden
    • Scotland
      • Edinburgh, Scotland, United Kingdom
        • Edinburgh Cancer Research Centre

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

Epithelial ovarian cancer (including fallopian tube or peritoneal cancer) patients that are or had received treatment with Olaparib.

Description

Inclusion Criteria:

  • Previous or current treatment with Olaparib in a clinical trial/standard of care that included one of the following as a first step study for epithelial ovarian cancer (including fallopian tube or peritoneal cancer):

    • single agent olaparib given for relapsed disease or
    • single agent olaparib given as maintenance therapy after response to platinum based chemotherapy or
    • olaparib combined with platinum based chemotherapy and then continued as maintenance therapy or
    • olaparib combined with other types of therapy
  • Had a durable response to Olaparib defined as patients who have benefited from olaparib for > 18 months. Patients who discontinued Olaparib due to toxicities but otherwise meet the definition of a durable response will be included or the control group is patients who had a short duration benefit with Olaparib of less than 6 months in any individual clinical trial/standard of care
  • Ability to understand and the willingness to sign a written informed consent document.
  • Patient's willingness and ability to comply with scheduled visits, laboratory tests, and other study procedures.

Exclusion Criteria:

  • Any severe acute or chronic medical or psychiatric condition or laboratory abnormality that would render the patient unsuitable for biopsy
  • Pregnant or breastfeeding women

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

  • Observational Models: Cohort
  • Time Perspectives: Other

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The number of patients with somatic BRCA mutations compared to number of patients without somatic BRCA mutations
Time Frame: 4 years
4 years
The number of patients with homologous recombination repair deficiencies compared to the number of patients that do not have homologous recombination repair deficiencies.
Time Frame: 4 years
4 years
The number and types of mutated genes.
Time Frame: 4 years
4 years
The number of patients with antibodies to the study drug
Time Frame: 4 years
4 years
Evaluate the levels of PI3K/Akt pathway expression per patient
Time Frame: 4 years
4 years

Secondary Outcome Measures

Outcome Measure
Time Frame
HRR deficiency profile
Time Frame: 4 years
4 years
Level of poly (ADP-ribose) (PAR) expression
Time Frame: 4 years
4 years
Signature of PARP response compared with signature of platinum sensitivity
Time Frame: 4 years
4 years
Signature of PARP response and PARP resistance on different tumour sites
Time Frame: 4 years
4 years

Collaborators and Investigators

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

Sponsor

University Health Network, Toronto

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 (Actual)

February 1, 2016

Primary Completion (Actual)

June 16, 2021

Study Completion (Actual)

August 31, 2022

Study Registration Dates

First Submitted

April 24, 2015

First Submitted That Met QC Criteria

July 1, 2015

First Posted (Estimate)

July 2, 2015

Study Record Updates

Last Update Posted (Estimate)

January 10, 2023

Last Update Submitted That Met QC Criteria

January 8, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OZM-061

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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