A Study of Long-Term Responders on Olaparib

Brief Title

A Study of Long-Term Responders on Olaparib

Official Title

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

Brief Summary

      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.

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

Primary Outcome

The number of patients with somatic BRCA mutations compared to number of patients without somatic BRCA mutations

Secondary Outcome

 HRR deficiency profile

Condition

Epithelial Ovarian Cancer

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Estimated Enrollment

Start Date

February 2016

Completion Date

August 31, 2021

Primary Completion Date

May 31, 2021

Eligibility Criteria

        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

Gender

Female

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Amit Oza, M.D., 416-946-2818,

Location Countries

Australia

Location Countries

Australia

Administrative Informations

NCT ID

NCT02489058

Organization ID

OZM-061

Responsible Party

Sponsor

Study Sponsor

University Health Network, Toronto

Study Sponsor

Amit Oza, M.D., Principal Investigator, Princess Margaret Cancer Centre

Verification Date

April 2021