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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)

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ClinicalTrials.gov Identifier: NCT02503436
Recruitment Status : Active, not recruiting
First Posted : July 21, 2015
Last Update Posted : October 15, 2019
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

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.

Condition or disease
Ovarian Cancer, Hereditary Ovarian Cancer Syndrome

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Study Type : Observational [Patient Registry]
Actual Enrollment : 276 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 84 Months
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
Actual Study Start Date : October 28, 2015
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : December 31, 2022





Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. 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 ]
  4. 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 ]
  5. 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 ]
  6. 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)

  7. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
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

Information from the National Library of Medicine

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): NCT02503436


  Show 68 Study Locations
Sponsors and Collaborators
AstraZeneca

Additional Information:

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Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT02503436     History of Changes
Other Study ID Numbers: D0816R00009
First Posted: July 21, 2015    Key Record Dates
Last Update Posted: October 15, 2019
Last Verified: October 2019
Keywords provided by AstraZeneca:
Ovarian Cancer, Fallopian Tube Cancer, primary peritoneal cancer, BRCA1 Gene, BRCA2 Gene
Additional relevant MeSH terms:
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Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Olaparib
Poly(ADP-ribose) Polymerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents