Ignite Creation Date:
2024-05-06 @ 3:15 PM
Last Modification Date:
2024-10-26 @ 1:45 PM
Study NCT ID:
NCT04560452
Status:
RECRUITING
Last Update Posted:
2024-06-04
First Post:
2020-09-07
Brief Title:
Drug Intensive Monitoring Study of Olaparib in Clinical Practice Among Chinese Patients
Sponsor:
AstraZeneca
Organization:
AstraZeneca
Study Overview
Official Title:
A Multi-Centre Prospective Non-Interventional Study to Intensively Monitor the Safety of Olaparib in Clinical Practice Among Chinese Patients
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a multi-centre prospective non-interventional study The study will enrol about 1000 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 n800 For PC cohort according to the doctors decision patients who have prescribed and agreed to start taking at least one dose of Olaparib will be enrolled n200 Patients treating physician is in charge of prescribing including dose-adjusting or interruption or discontinuation of olaparib
Detailed Description:
The study will enrol about 1000 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 n800 For PC cohort according to the doctors decision patients who have prescribed and agreed to start taking at least one dose of Olaparib will be enrolled n200 Patients 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 enrolmentEvery 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 patients 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
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 enrolmentEvery 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 patients 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None