Drug Intensive Monitoring Study of Olaparib in Clinical Practice Among Chinese Patients

Prostate Cancer Clinical Trial

Official title:

A Multi-Centre, Prospective, Non-Interventional Study to Intensively Monitor the Safety of Olaparib in Clinical Practice Among Chinese Patients.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04560452
• Other study ID #: D0817R00011
• Status: Recruiting
• Start date: March 15, 2021
• Est. completion date: December 31, 2025

Study information

• Verified date: April 2024
• Source: AstraZeneca
• Contact: AstraZeneca Clinical Study Information Center
• Phone: 1-877-240-9479
• Email: information.center[@]astrazeneca.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Ovarian Cancer
• Prostate Cancer

Locations

Country	Name	City	State
China	Research Site	Anhui
China	Research Site	Beijing
China	Research Site	Beijing
China	Research Site	Beijing	Beijing
China	Research Site	Changsha
China	Research Site	Chengdu
China	Research Site	Chengdu
China	Research Site	Chongqing
China	Research Site	Dalian
China	Research Site	Dongguan
China	Research Site	Foshan
China	Research Site	Guangzho
China	Research Site	Guangzhou
China	Research Site	Guangzhou
China	Research Site	Guizhou
China	Research Site	Hangzhou
China	Research Site	Hangzhou
China	Research Site	Harbin
China	Research Site	Henan
China	Research Site	Henan
China	Research Site	Huizhou
China	Research Site	JingHou
China	Research Site	Langfang
China	Research Site	Luzhou
China	Research Site	Nanchang
China	Research Site	Nanjing
China	Research Site	Nanjing
China	Research Site	Nantong
China	Research Site	Nantong
China	Research Site	Ningbo
China	Research Site	Shandong
China	Research Site	Shandong
China	Research Site	Shanghai
China	Research Site	Shanghai
China	Research Site	Shanghai
China	Research Site	Shanghai	Shanghai
China	Research Site	Shantou
China	Research Site	Shenyang
China	Research Site	Shenyang
China	Research Site	Shenzhen
China	Research Site	Shijazhuang
China	Research Site	Taiyuan
China	Research Site	Taiyuan
China	Research Site	Tianjin
China	Research Site	Tianjin
China	Research Site	Xi'an
China	Research Site	Xiamen
China	Research Site	Yichang
China	Research Site	Yunnan
China	Research Site	Zhangjiagang
China	Research Site	Zhengzhou
China	Research Site	Zhengzhou

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number and percentage of patients with AEs as well as number of AE events as assessed by CTCAE	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.	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	Number and percentage of patients with AEs as well as number of AE events as assessed by CTCAE	To describe the safety and tolerability of olaparib in special populations (including patients with hepatic impairment or renal impairment, elderly patients with age > 65 years old) in Chinese patients by assessing the incidence, seriousness, causality, severity and action taken (interruption/dose reduction/discontinuation) of all AEs (including AESIs) among enrolled special populations. 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 for special populations.	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.
Secondary	Progression-free survival(PFS) for PC cohort	PFS will be measured as the date of treatment initiation, until investigator-reported progression or death due to any cause, whichever occurs first for PC cohort.	From the date of treatment initiation, until investigator-reported progression or death, up to 12 months.
Secondary	PFS rate at one year for PC cohort	PFS rate at one year is defined as the proportion of patients who are alive and progression free at 12 months after the start of treatment for PC cohort.	From the date of treatment initiation, until investigator-reported progression or death, up to 12 months.
Secondary	Time to treatment discontinuation(TTTD) for PC cohort	TTTD will be measured as the date of treatment initiation, until the earlier of the date of treatment discontinuation or death for PC cohort.	From the date of treatment initiation, until the earlier of the date of treatment discontinuation or death, up to 12 months.
Secondary	Number and percentage of patients with different treatment pattern for PC cohort	Number and percentage of patients with different treatment pattern,which will be classified by concomitant medications and procedures including surgery, radiation therapy, chemotherapy and hormone therapy (including castration therapy and anti-androgen therapy) 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.