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

Ovarian 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 Summary

This is a multi-centre, prospective, non-interventional study. The study will enrol about 1,500 Chinese cancer patients from around 30 sites who had received olaparib for at least one dose before study enrolment in real world practices in approved tumor types. Patient's treating physician is in charge of prescribing (including dose-adjusting or interruption) or discontinuation of olaparib

Clinical Trial Description

The study will recruit about 1,500 Chinese cancer patients from around 30 sites who received at least one dose of olaparib treatment before study enrolment in real world practice in approved tumor types.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 8 months after enrolment if treatment continues. 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 adverse events of special interest [AESIs]). ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04560452
Study type Observational
Source AstraZeneca
Contact AstraZeneca Clinical Study Information Center
Phone 1-877-240-9479
Email information.center@astrazeneca.com
Status Recruiting
Phase
Start date June 11, 2021
Completion date April 30, 2025
View Details
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