Clinical trial NCT04560452: Drug Intensive Monitoring Study of Olaparib in Clinical Practice Among Chinese Patients
Official title: A Multi-Centre, Prospective, Non-Interventional Study to Intensively Monitor the Safety of Olaparib in Clinical Practice Among Chinese Patients.
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Ovarian Cancer
Prostate Cancer
Keywords: OC and PC
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2020-09-23
Enrollment: 1013
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The study will recruit about 1000Chinese cancer patients from around 56 sites in real world practice in approved tumor types.

Brief summary: This is a multi-centre, prospective, non-interventional study. 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=200). Patient's treating physician is in charge of prescribing (including dose-adjusting or interruption) or discontinuation of olaparib.

Detailed description: 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=200). 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).

Eligibility criteria: Inclusion Criteria

* 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

Exclusion Criteria

• In other ongoing studies, which prohibit any participation in this non-interventional study judged by investigator.

Primary outcomes:
measure: Number and percentage of patients with AEs as well as number of AE events as assessed by CTCAE
timeFrame: 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.
Secondary outcomes:
measure: Number and percentage of patients with AEs as well as number of AE events as assessed by CTCAE
timeFrame: 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.
measure: Progression-free survival(PFS) for PC cohort
timeFrame: From the date of treatment initiation, until investigator-reported progression or death, up to 12 months.
measure: PFS rate at one year for PC cohort
timeFrame: From the date of treatment initiation, until investigator-reported progression or death, up to 12 months.
measure: Time to treatment discontinuation(TTTD) for PC cohort
timeFrame: From the date of treatment initiation, until the earlier of the date of treatment discontinuation or death, up to 12 months.
measure: Number and percentage of patients with different treatment pattern for PC cohort
timeFrame: From the time of signature of informed consent, throughout the treatment period and until the end of study follow-up, up to 12 months.
Other outcomes:
Locations:
city: Anhui
country: China
facility: Research Site
city: Beijing
country: China
facility: Research Site
city: Changsha
country: China
facility: Research Site
city: Chengdu
country: China
facility: Research Site
city: Chongqing
country: China
facility: Research Site
city: Dongguan
country: China
facility: Research Site
city: Foshan
country: China
facility: Research Site
city: Fujian
country: China
facility: Research Site
city: Guangdong
country: China
facility: Research Site
city: Guangzhou
country: China
facility: Research Site
city: Guangzho
country: China
facility: Research Site
city: Guizhou
country: China
facility: Research Site
city: Hangzhou
country: China
facility: Research Site
city: He'nan
country: China
facility: Research Site
city: Hebei
country: China
facility: Research Site
city: Heilongjiang
country: China
facility: Research Site
city: Henan
country: China
facility: Research Site
city: Huizhou
country: China
facility: Research Site
city: Jiangsu
country: China
facility: Research Site
city: Jiangxi
country: China
facility: Research Site
city: Jilin
country: China
facility: Research Site
city: JingHou
country: China
facility: Research Site
city: Liaoning
country: China
facility: Research Site
city: Luzhou
country: China
facility: Research Site
city: Nanjing
country: China
facility: Research Site
city: Nantong
country: China
facility: Research Site
city: Ningbo
country: China
facility: Research Site
city: Shandong
country: China
facility: Research Site
city: Shanghai
country: China
facility: Research Site
city: Shenyang
country: China
facility: Research Site
city: Sichuan
country: China
facility: Research Site
city: Taiyuan
country: China
facility: Research Site
city: Tianjin
country: China
facility: Research Site
city: Yichang
country: China
facility: Research Site
city: Yunan
country: China
facility: Research Site
city: Zhejiang
country: China
facility: Research Site
city: Zhengzhou
country: China
facility: Research Site
Study officials:
affiliation: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
name: Zhongqiu Lin
role: PRINCIPAL_INVESTIGATOR
References: