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

Active, not recruiting

• Conditions: Ovarian Cancer; Prostate Cancer

• Registration Number: NCT04560452
• Lead Sponsor: AstraZeneca

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).

Study Timeline

• Study First Submitted: 2020-09-07
• Study First Submitted QC: 2020-09-17
• Study First Posted: 2020-09-23
• Study Start: 2021-03-15
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-31
• Last Update Posted: 2025-04-01
• Primary Completion: 2025-09-30
• Study Completion: 2025-09-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 1013

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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, 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.

Secondary Outcome Measures

Name	Time	Method
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.	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.
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.	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.
Progression-free survival(PFS) for PC cohort	From the date of treatment initiation, until investigator-reported progression or death, up to 12 months.	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.
PFS rate at one year for PC cohort	From the date of treatment initiation, until investigator-reported progression or death, up to 12 months.	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.
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.	TTTD will be measured as the date of treatment initiation, until the earlier of the date of treatment discontinuation or death for PC cohort.

Trial Locations

Locations (1)

Research Site; 🇨🇳 Zhengzhou, China