Epithelial Ovarian CancerOLALANCT02489058
A Study of Long-Term Responders on Olaparib
An observational study of Epithelial Ovarian Cancer and Fallopian Tube Cancer, run by University Health Network, Toronto at 8 sites in 5 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Epithelial Ovarian Cancer, Fallopian Tube Cancer, Peritoneal Cancer
- How many people
- 118 participants
- Where
- 8 sitesin 5 countries
- Study dates
- Feb 2016to 31 Aug 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Epithelial ovarian cancer (including fallopian tube or peritoneal cancer) patients that are or had received treatment with Olaparib.
Who may be able to join
- 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.
Who cannot join
- Any severe acute or chronic medical or psychiatric condition or laboratory abnormality that would render the patient unsuitable for biopsy
- Pregnant or breastfeeding women
Trial locations and contacts
8 sites in 5 countries.
8 sites in 5 countries
Canada3 sites
Ottawa Hospital Research Institute
Ottawa, Ontario
Princess Margaret Cancer Centre
Toronto, Ontario, M5G 2M9
British Columbia Cancer Centre
Vancouver, British Columbia, V5Z 4E6
United Kingdom2 sites
Edinburgh Cancer Research Centre
Edinburgh, Scotland
The Royal Marsden
Sutton, England, SM2 5PT
Australia1 site
South Eastern Sydney Local Health District
Randwick, New South Wales, 2031
About this study
Official title: 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.
Read the 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.
- Medical subject headings
- Carcinoma, Ovarian Epithelial, Fallopian Tube Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of patients with somatic BRCA mutations compared to number of patients without somatic BRCA mutations
Measured: 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.
Measured: 4 years
The number and types of mutated genes.
Measured: 4 years
The number of patients with antibodies to the study drug
Measured: 4 years
Evaluate the levels of PI3K/Akt pathway expression per patient
Measured: 4 years
Secondary outcomes (4)
HRR deficiency profile
Measured: 4 years
Level of poly (ADP-ribose) (PAR) expression
Measured: 4 years
Signature of PARP response compared with signature of platinum sensitivity
Measured: 4 years
Signature of PARP response and PARP resistance on different tumour sites
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2015 (estimated)
- Study startFeb 2016
- Primary completion16 Jun 2021
- Study completion31 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Epithelial Ovarian CancerStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 118 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Amit Oza, M.D., Principal investigator, Princess Margaret Cancer Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02489058
- Sponsor's protocol ID
- OZM-061
- Acronym
- OLALA
- Status last verified
- Jan 2023
- First submitted
- 24 Apr 2015
- Last updated
- 10 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Retrospective/Prospective Analysis of Characterization of the Long-Term Responders on Olaparib in Solid Tumours
- ClinicalTrials.gov ID
- NCT02489058
- Acronym / sponsor ID
- OLALA / OZM-061
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 118 participants (actual)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- Feb 2016 (actual)
- Primary completion
- 16 Jun 2021 (actual)
- Study completion
- 31 Aug 2022 (actual)
- First posted
- 2 Jul 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Other
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Epithelial ovarian cancer (including fallopian tube or peritoneal cancer) patients that are or had received treatment with Olaparib.
Key inclusion criteria (8 listed)
- 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):
- 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.
Key exclusion criteria (2 listed)
- Any severe acute or chronic medical or psychiatric condition or laboratory abnormality that would render the patient unsuitable for biopsy
- Pregnant or breastfeeding women
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The number of patients with somatic BRCA mutations compared to number of patients without somatic BRCA mutations
Time frame: 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
The number and types of mutated genes.
Time frame: 4 years
The number of patients with antibodies to the study drug
Time frame: 4 years
Evaluate the levels of PI3K/Akt pathway expression per patient
Time frame: 4 years
4 secondary outcomes
HRR deficiency profile
Time frame: 4 years
Level of poly (ADP-ribose) (PAR) expression
Time frame: 4 years
Signature of PARP response compared with signature of platinum sensitivity
Time frame: 4 years
Signature of PARP response and PARP resistance on different tumour sites
Time frame: 4 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2023.
Related trials for Epithelial Ovarian Cancer
RecruitingPhase 2
Immunotherapy Platform Study in Platinum Resistant High Grade Serous Ovarian Cancer
Ovarian Cancer
Not yet recruitingPhase 2
Study of Suvemcitug Plus Chemotherapy in Advanced High-Grade Serous Ovarian Cancer
High-grade Serous Ovarian Cancer
Active, not recruitingPhase 2
Measuring the Effects of Talazoparib in Patients With Advanced Cancer and DNA Repair Variations
Anatomic Stage III Breast Cancer AJCC v8, Anatomic Stage IV Breast Cancer AJCC v8
RecruitingPhase 3
A Study of Raludotatug Deruxtecan With or Without Bevacizumab as First-Line Maintenance Treatment in Non-HRD-Positive Advanced Ovarian Cancer (MK-5909-006, (ENGOT-ov102/GOG-3141/ REJOICE-Ovarian 04)
Ovarian Cancer, Ovarian Neoplasms
RecruitingPhase 2
Sacituzumab Govitecan With Bevacizumab Compared to Usual Chemotherapy (Carboplatin, Pegylated Liposomal Doxorubicin and Bevacizumab) for Treating Recurrent Platinum-Sensitive Ovarian Cancer After PARP Inhibitor Maintenance Therapy
Recurrent Platinum-Sensitive Fallopian Tube Endometrioid Adenocarcinoma, Recurrent Platinum-Sensitive Fallopian Tube High Grade Serous Adenocarcinoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amit Oza, M.D. principal investigator
Princess Margaret Cancer Centre
8 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Epithelial Ovarian Cancer and Fallopian Tube Cancer, run by University Health Network, Toronto at 8 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Canada, United Kingdom, Australia, Italy, Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The number of patients with somatic BRCA mutations compared to number of patients without somatic BRCA mutations (time frame: 4 years). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jan 2023.