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
100
Start Date
February 2016
Completion Date
March 31, 2021
Primary Completion Date
December 31, 2020
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
September 2020