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C-PATROL - Non-interventional Study (NIS) to Collect Clinical and Patient Reported Outcome Data in an Olaparib Treated BRCAm+ PSR Ovarian Cancer Population | Clinical Trials | Clareo Health

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C-PATROL - Non-interventional Study (NIS) to Collect Clinical and Patient Reported Outcome Data in an Olaparib Treated BRCAm+ PSR Ovarian Cancer Population

C-PATROL - a Single Arm, Prospective Non-interventional Study (NIS) to Collect Clinical and Patient Reported Outcome Data in an Olaparib Treated BRCAm+ PSR Ovarian Cancer Population

NCT02503436•AstraZeneca

View on ClinicalTrials.gov

Summary

The main objective of the proposed non-interventional study is to obtain real-world effectiveness, safety and treatment patterns data of patients with BRCAm+ (Breast Cancer Gene(s) mutation positive) platinum sensitive relapsed (PSR) ovarian cancer in German hospitals and outpatient practices treated with olaparib.

Eligibility

Age

18 - No limit years

Sex

FEMALE

Healthy Volunteers

Inclusion Criteria

•Signed written informed consent
•Women aged ≥ 18 years
•Patients with platinum sensitive relapsed high grade epithelial ovarian cancers (including primary peritoneal and/or fallopian tube cancer). (Platinum sensitive disease is defined as disease progression ≥6 months after completion of their last dose of platinum based chemotherapy. Patients must be currently in response to platinum-based chemotherapy. For the last chemotherapy course immediately prior to enrolment on the study, patients must be, in the opinion of the investigator, in response (partial or complete), following completion of this chemotherapy course.
•Documented BRCA mutations (germline and/or somatic mutation in BRCA1 (Breast Cancer gene 1) and/or BRCA2 (Breast Cancer gene 2) that is predicted to be deleterious or suspected deleterious (known or predicted to be detrimental/lead to loss of function))
•Patients should be in line with the specifications mentioned in the German LYNPARZA (olaparib) SmPC (Summary Product Characteristics) for hard capsules or tablets.
•Patients are able to read and understand German, English, Turkish or Arabic

Exclusion Criteria

•Known hypersensitivity to olaparib or any of the excipients of the drug
•Patients who have started olaparib monotherapy for more than 14 days before giving their informed consent
•Pregnancy or breast feeding

Locations (68)

Research Site

Amberg, Germany

Research Site

Aschaffenburg, Germany

Research Site

Augsburg, Germany

Research Site

Bad Homburg, Germany

Research Site

Berlin, Germany

Research Site

Bonn, Germany

Research Site

Bottrop, Germany

Research Site

Brandenburg, Germany

Research Site

Braunschweig, Germany

Research Site

Bremen, Germany

Key Dates

Start Date

October 28, 2015

Primary Completion Date

December 1, 2022

Completion Date

December 1, 2022

Last Updated

December 4, 2023

Enrollment

276

ACTUAL participants

Conditions

Ovarian Cancer, Hereditary Ovarian Cancer Syndrome