NCT02489058

A Study of Long-Term Responders on Olaparib

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 118 (actual)
• Sponsor: University Health Network, Toronto · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Epithelial Ovarian Cancer
• Fallopian Tube Cancer
• Peritoneal Cancer

Timeline

• Start date: 2016-02-01
• Primary completion: 2021-06-16
• Completion: 2022-08-31
• First posted: 2015-07-02
• Last updated: 2023-01-10

Locations

8 sites across 5 countries: Australia, Canada, Italy, Spain, United Kingdom