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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 16, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 31, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 24, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 1, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 2, 2015

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 10, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 8, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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