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临床试验/NCT02503436
NCT02503436已完成不适用

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

AstraZeneca1 个研究点 分布在 1 个国家目标入组 276 人开始时间: 2015年10月28日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
AstraZeneca
入组人数
276
试验地点
1
主要终点
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.

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

结局指标

主要结局

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.

时间窗: 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

次要结局

  • Progression-free survival 2 (PFS2)(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 discontinuation of olaparib monotherapy (TDO)(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)
  • Safety of Olaparib: collection of Adverse Events (AE)(Date of first documented dose of Olaparib to last visit, assessed approximately up to 84 months)
  • To collect and explore real-life data on patient outcomes in terms of Overall Survival (OS)(Date of first documented dose of olaparib to death of any cause, assessed approximately up to 84 months)
  • Time to second subsequent therapy (TSST)(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 first subsequent therapy (TFST)(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)
  • Assessment of health-related quality of life (HRQoL) in patients participating in the study.(Date of first visit to last visit. HRQoL are collected every 3 months up to 84 months)

研究者

发起方
AstraZeneca
申办方类型
Industry
责任方
Sponsor

研究点 (1)

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