A Multi-Centre, Prospective, Non-Interventional Study to Intensively Monitor the Safety of Olaparib in Clinical Practice Among Chinese Patients.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 1,018
- 试验地点
- 38
- 主要终点
- Number and percentage of patients with AEs as well as number of AE events as assessed by CTCAE
研究概览
简要总结
This is a multi-centre, prospective, non-interventional study. The study will enrol about 860 Chinese cancer patients from around 56 sites. For OC cohort, the subjects who had received olaparib for at least one dose before study enrolment in real world practices will be enrolled ( n=800) . For PC cohort, according to the doctor's decision, patients who have prescribed and agreed to start taking at least one dose of Olaparib will be enrolled ( n=60). Patient's treating physician is in charge of prescribing (including dose-adjusting or interruption) or discontinuation of olaparib.
详细描述
The study will enrol about 1,000 Chinese cancer patients from around 56 sites. For OC cohort, the subjects who had received olaparib for at least one dose before study enrolment in real world practices will be enrolled ( n=800) . For PC cohort, according to the doctor's decision, patients who have prescribed and agreed to start taking at least one dose of Olaparib will be enrolled ( n=60). Patient's treating physician is in charge of prescribing (including dose-adjusting or interruption) or discontinuation of olaparib.
The recruited patients will be followed up according to standard clinical practice. They will be tracked up to 30 days after discontinuation of olaparib treatment, or 6 months for Cohort OC, 12 months for Cohort PC after enrolment.Every OC patient will be followed maximum of 6 months after enrolment as Olaparib AEs most occur in first 6m and PC patient will be followed maximum of 12 months to observe 1-year PFS. Any adverse events (AEs) that are ongoing at the patient's last visit in the study must be followed up by the investigator for as long as medically indicated, but without further recording in the electronic case report form (eCRF).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Provision of signed and dated written informed consent by the patient or legally acceptable representative prior to any study-specific procedures
- •Patients diagnosed as olaparib approved tumor types in China
- •Eligible for olaparib treatment per the judgement of the treating physician in clinical practice
- •For OC cohort: at least take one tablet of olaparib before enrolment
- •For PC cohort: according to the doctor's decision, have prescribed and agreed to start taking at least one dose of Olaparib
排除标准
- •In other ongoing studies, which prohibit any participation in this non-interventional study judged by investigator.
结局指标
主要结局
Number and percentage of patients with AEs as well as number of AE events as assessed by CTCAE
时间窗: from the time of signature of informed consent, throughout the treatment period and until the end of study follow-up, up to 6 months for Cohort OC, 12 months for Cohort PC after enrolment.
The primary objective of this study is to describe the safety and tolerability of olaparib in Chinese patients by assessing the incidence, seriousness, causality, severity and action taken (interruption/dose reduction/discontinuation) of all AEs (including AESIs) among all enrolled patients (including OC and PC patients as a whole). The number and percentage of patients with AEs as well as number of AE events will be summarized by Medical Dictionary for Regulatory Activities (MedDRA) preferred terms and Common Terminology Criteria for Adverse Events (CTCAE) grade.
次要结局
- Number and percentage of patients with AEs as well as number of AE events as assessed by CTCAE(from the time of signature of informed consent, throughout the treatment period and until the end of study follow-up in special populations, up to 6 months for Cohort OC, 12 months for Cohort PC after enrolment.)
- Number and percentage of patients with different treatment pattern for PC cohort(From the time of signature of informed consent, throughout the treatment period and until the end of study follow-up, up to 12 months.)
- Progression-free survival(PFS) for PC cohort(From the date of treatment initiation, until investigator-reported progression or death, up to 12 months.)
- PFS rate at one year for PC cohort(From the date of treatment initiation, until investigator-reported progression or death, up to 12 months.)
- Time to treatment discontinuation(TTTD) for PC cohort(From the date of treatment initiation, until the earlier of the date of treatment discontinuation or death, up to 12 months.)