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

AstraZeneca

Status

Active, not recruiting

Conditions

Ovarian Cancer

Prostate Cancer

Study type

Observational

Funder types

Industry

Identifiers

NCT04560452

D0817R00011

Details and patient eligibility

About

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.

Full 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).

Enrollment

1,013 patients

Sex

All

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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.