A Study of Long-Term Responders on Olaparib (OLALA)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02489058|
Recruitment Status : Recruiting
First Posted : July 2, 2015
Last Update Posted : September 14, 2018
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|
|Epithelial Ovarian Cancer Fallopian Tube Cancer Peritoneal Cancer|
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|
|Estimated Enrollment :||100 participants|
|Official Title:||A Retrospective/Prospective Analysis of Characterization of the Long-Term Responders on Olaparib in Solid Tumours|
|Actual Study Start Date :||February 2016|
|Estimated Primary Completion Date :||July 2019|
|Estimated Study Completion Date :||December 2019|
- 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 ]
- 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 ]
Biospecimen Retention: Samples With DNA
- Archival tumor tissue sample for biomarker research
- Optional fresh tumor tissue sample for biomarker research (if participants are still on olaparib and their disease progressed)
- Blood sample for pharmacokinetics (if participants are still on olaparib)
- Blood sample for pharmacogenomics (if participants are still on olaparib and their disease progressed)
- Blood samples for circulating tumor DNA (if participants are still on olaparib)
- Blood sample for germline BRCA1/2 testing if not previously done (if participants are still on olaparib and their disease progressed)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02489058
|Contact: Amit M. Oza, M.D.||416-946-2818|
|Canada, British Columbia|
|British Columbia Cancer Centre||Recruiting|
|Vancouver, British Columbia, Canada, V5Z 4E6|
|Contact: Frances Topp, RN 604-877-6000 ext 2637|
|Principal Investigator: Anna Tinker, M.D.|
|Ottawa Hospital Research Institute||Not yet recruiting|
|Ottawa, Ontario, Canada|
|Contact: Johanne Weberpals, M.D. 613-737-7700 ext 76462|
|Principal Investigator: Johanne Weberpals, M.D.|
|Princess Margaret Cancer Centre||Recruiting|
|Toronto, Ontario, Canada, M5G 2M9|
|Contact: Amit Oza, M.D. 416-946-2818|
|Principal Investigator: Amit Oza, M.D.|
|Institute of European Oncology||Not yet recruiting|
|Contact: Nicoletta Colombo, M.D.|
|Principal Investigator: Nicoletta Colombo, M.D.|
|Vall d'Hebron||Not yet recruiting|
|Contact: Nuria Collantes (+34)93 274 6000 ext 4691|
|Principal Investigator: Ana Oaknin, M.D.|
|Edinburgh Cancer Research Centre||Recruiting|
|Edinburgh, Scotland, United Kingdom|
|Contact: Charlie Gourley, M.D. 0131 537 3053|
|Principal Investigator: Charlie Gourley|
|Principal Investigator:||Amit Oza, M.D.||Princess Margaret Cancer Centre|