OLALA: A Study of Long-Term Responders on Olaparib
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
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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
Outcome Measures
Primary Outcome Measures
- The number of patients with somatic BRCA mutations compared to number of patients without somatic BRCA mutations [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. [4 years]
- The number and types of mutated genes. [4 years]
- The number of patients with antibodies to the study drug [4 years]
- Evaluate the levels of PI3K/Akt pathway expression per patient [4 years]
Secondary Outcome Measures
- HRR deficiency profile [4 years]
- Level of poly (ADP-ribose) (PAR) expression [4 years]
- Signature of PARP response compared with signature of platinum sensitivity [4 years]
- Signature of PARP response and PARP resistance on different tumour sites [4 years]
Eligibility Criteria
Criteria
Inclusion Criteria:
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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):
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single agent olaparib given for relapsed disease or
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single agent olaparib given as maintenance therapy after response to platinum based chemotherapy or
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olaparib combined with platinum based chemotherapy and then continued as maintenance therapy or
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olaparib combined with other types of therapy
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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
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Ability to understand and the willingness to sign a written informed consent document.
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Patient's willingness and ability to comply with scheduled visits, laboratory tests, and other study procedures.
Exclusion Criteria:
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Any severe acute or chronic medical or psychiatric condition or laboratory abnormality that would render the patient unsuitable for biopsy
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Pregnant or breastfeeding women
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | South Eastern Sydney Local Health District | Randwick | New South Wales | Australia | 2031 |
| 2 | British Columbia Cancer Centre | Vancouver | British Columbia | Canada | V5Z 4E6 |
| 3 | Ottawa Hospital Research Institute | Ottawa | Ontario | Canada | |
| 4 | Princess Margaret Cancer Centre | Toronto | Ontario | Canada | M5G 2M9 |
| 5 | Institute of European Oncology | Milan | Italy | ||
| 6 | Vall d'Hebron | Barcelona | Spain | ||
| 7 | The Royal Marsden | Sutton | England | United Kingdom | SM2 5PT |
| 8 | Edinburgh Cancer Research Centre | Edinburgh | Scotland | United Kingdom |
Sponsors and Collaborators
- University Health Network, Toronto
Investigators
- Principal Investigator: Amit Oza, M.D., Princess Margaret Cancer Centre
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- OZM-061