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

Plain-language summary

This non-interventional study aims to collect clinical and patient-reported outcome data in women with BRCA-mutated, platinum-sensitive relapsed ovarian cancer who are being treated with Olaparib. Women aged 18 and over with a documented BRCA mutation and platinum-sensitive relapsed epithelial ovarian cancer may take part. It was carried out as an observational study with no assigned phase and has been completed.

The summary above is a plain-language rendering of the official record. The original English title is shown for reference.

Trial details

Phase

N/A

Status

Completed

Sponsor

AstraZeneca

Start date

10/28/2015

Estimated completion

12/1/2022

Countries

Germany

Related genes

Locations

• Amberg, Germany
• Aschaffenburg, Germany
• Augsburg, Germany
• Bad Homburg, Germany
• Berlin, Germany
• Bonn, Germany
• Bottrop, Germany
• Brandenburg an der Havel, Germany
• Braunschweig, Germany
• Bremen, Germany
• Chemnitz, Germany
• Coburg, Germany
• Cologne, Germany
• Donauwörth, Germany
• Dortmund, Germany
• Dresden, Germany
• Duisburg, Germany
• Düsseldorf, Germany
• Erlangen, Germany
• Essen, Germany
• Esslingen am Neckar, Germany
• Eutin, Germany
• Frankfurt, Germany
• Freiburg im Breisgau, Germany
• Fürstenwalde, Germany
• Georgsmarienhütte, Germany
• Halle, Germany
• Hamburg, Germany
• Hanover, Germany
• Heidelberg, Germany
• Heidenheim, Germany
• Hildesheim, Germany
• Homburg/Saar, Germany
• Jena, Germany
• Karlsruhe, Germany
• Kassel, Germany
• Kempten, Germany
• Kiel, Germany
• Krefeld, Germany
• Kulmbach, Germany

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Eligibility criteria

Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.

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