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)

• ClinicalTrials.gov Identifier: NCT02503436
• Recruitment Status: Completed
• First Posted: July 21, 2015
• Last Update Posted: January 10, 2023
• Sponsor: AstraZeneca
• Information provided by (Responsible Party): AstraZeneca

Tracking Information

• First Submitted Date: July 8, 2015
• First Posted Date: July 21, 2015
• Last Update Posted Date: January 10, 2023
• Actual Study Start Date: October 28, 2015
• Actual Primary Completion Date: December 1, 2022 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: October 9, 2018): To assess clinical effectiveness of olaparib maintenance monotherapy by assessment of progression free survival (PFS) in patients with BRCAm+ ovarian cancer. Methods and time intervals for tumor assessment depend on the investigator's decision. [ Time Frame: Date of first documented dose of olaparib to the date of progression (as judged by the investigator) or death (of any cause) whichever occurred before, assessed approximately up to 84 months ]
• Original Primary Outcome Measures (submitted: July 17, 2015): To assess clinical effectiveness of olaparib maintenance monotherapy by assessment of progression free survival (PFS) in patients with BRCAm+ ovarian cancer. Methods and time intervals for tumor assessment depend on the investigator's decision. [ Time Frame: Date of first documented dose of olaparib to the date of progression (as judged by the investigator) or death (of any cause) whichever occurred before, assessed approximately up to 66 months ]

Current Secondary Outcome Measures (submitted: October 9, 2018)

• To collect and explore real-life data on patient outcomes in terms of Overall Survival (OS) [ Time Frame: Date of first documented dose of olaparib to death of any cause, assessed approximately up to 84 months ]
• Time to first subsequent therapy (TFST) [ Time Frame: Date of first documented dose of olaparib to date of first administration of first subsequent therapy or death if this occurs before commencement of first subsequent treatment, assessed approximately up to 84 months ]
• Progression-free survival 2 (PFS2) [ Time Frame: Date of first administration of first subsequent therapy to date of progression as assessed by the investigator or death, assessed approximately up to 84 months ]
• Time to second subsequent therapy (TSST) [ Time Frame: Date of first documented dose of olaparib to date of first administration of second subsequent therapy or death if this occurs before commencement of second subsequent treatment, assessed approximately up to 84 months ]
• Time to discontinuation of olaparib monotherapy (TDO) [ Time Frame: Date of first documented dose of olaparib montherapy to date of last documented dose of olaparib monotherapy or death whichever occurred before, assessed approximately up to 84 months ]
• Assessment of health-related quality of life (HRQoL) in patients participating in the study. [ Time Frame: Date of first visit to last visit. HRQoL are collected every 3 months up to 84 months ]
  Health related quality of life (HRQoL): Assessment of general cancer-associated and specific ovarian cancer associated parameters by use of standardized HRQoL questionnaires:

  • Functional assessment of Cancer Therapy for Patients with Ovarian Cancer (FACT-O)
  • Functional Assessment of Chronic Illness - Fatigue (FACIT-Fatigue)
  • Functional Living Index - Emesis (FLIE)
• Safety of Olaparib: collection of Adverse Events (AE) [ Time Frame: Date of first documented dose of Olaparib to last visit, assessed approximately up to 84 months ]
  Type and frequeny of adverse event (AE), intensity, causal relationship to olaparib, outcome, seriousness, management of adverse event

Original Secondary Outcome Measures (submitted: July 17, 2015)

• To collect and explore real-life data on patient outcomes in terms of Overall Survival (OS) [ Time Frame: Date of first documented dose of olaparib to death of any cause, assessed approximately up to 66 months ]
• Time to first subsequent therapy (TFST) [ Time Frame: Date of first documented dose of olaparib to date of first administration of first subsequent therapy or death if this occurs before commencement of first subsequent treatment, assessed approximately up to 66 months ]
• Progression-free survival 2 (PFS2) [ Time Frame: Date of first administration of first subsequent therapy to date of progression as assessed by the investigator or death, assessed approximately up to 66 months ]
• Time to second subsequent therapy (TSST) [ Time Frame: Date of first documented dose of olaparib to date of first administration of second subsequent therapy or death if this occurs before commencement of second subsequent treatment, assessed approximately up to 66 months ]
• Time to discontinuation of olaparib monotherapy (TDO) [ Time Frame: Date of first documented dose of olaparib montherapy to date of last documented dose of olaparib monotherapy or death whichever occurred before, assessed approximately up to 66 months ]
• Assessment of health-related quality of life (HRQoL) in patients undergoing treatment with olaparib [ Time Frame: Date of first visit to last visit. HRQoL are collected every 3 months up to 66 months ]
  Health related quality of life (HRQoL): Assessment of general cancer-associated and specific ovarian cancer associated parameters by use of standardized HRQoL questionnaires:

  • Functional assessment of Cancer Therapy for Patients with Ovarian Cancer (FACT-O)
  • Functional Assessment of Chronic Illness - Fatigue (FACIT-Fatigue)
  • Functional Living Index - Emesis (FLIE)
• Safety of Olaparib: collection of Adverse Events (AE) [ Time Frame: Date of first documented dose of Olaparib to last visit, assessed approximately up to 66 months ]
  Type and frequeny of adverse event (AE), intensity, causal relationship to olaparib, outcome, seriousness, management of adverse event

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: C-PATROL - Non-interventional Study (NIS) to Collect Clinical and Patient Reported Outcome Data in an Olaparib Treated BRCAm+ PSR Ovarian Cancer Population
• Official Title: 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
• Brief 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.
• Detailed Description: Not Provided
• Study Type: Observational [Patient Registry]
• Study Design: Observational Model: Cohort; Time Perspective: Prospective
• Target Follow-Up Duration: 84 Months
• Biospecimen: Not Provided
• Sampling Method: Probability Sample
• Study Population: 300 patients in 80 sites (approx. 40 hospitals and 40 outpatient practices) in Germany. Each site should enrol 2-30 patients
• Condition: Ovarian Cancer, Hereditary Ovarian Cancer Syndrome
• Intervention: Not Provided
• Study Groups/Cohorts: Not Provided
• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: October 14, 2019): 276
• Original Estimated Enrollment (submitted: July 17, 2015): 300
• Actual Study Completion Date: December 1, 2022
• Actual Primary Completion Date: December 1, 2022 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

Sex/Gender

• Sexes Eligible for Study: Female

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Germany

Administrative Information

• NCT Number: NCT02503436
• Other Study ID Numbers: D0816R00009
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: AstraZeneca
• Original Responsible Party: Same as current
• Current Study Sponsor: AstraZeneca
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: AstraZeneca
• Verification Date: January 2023