'OLAP' (OLAparib Regulatory Post-marketing Surveillance)

Lynparza Tablet (Olaparib) Regulatory Post-Marketing Surveillance

Sponsors

Lead Sponsor: AstraZeneca

Source AstraZeneca
Brief Summary

The objectives of this study are to assess safety and effectiveness of Lynparza tablet (olaparib, hereinafter "the study drug") in a real world setting in patients who are prescribed with the study drug according to the approved indications in South Korea.

Detailed Description

Primary Objective: To assess the safety of the study drug for patients prescribed with the study drug under the approved indications in South Korea Secondary Objective: To assess effectiveness of the study drug for patients prescribed with the study drug under the approved indication in South Korea

Overall Status Not yet recruiting
Start Date December 31, 2020
Completion Date December 31, 2024
Primary Completion Date December 31, 2024
Study Type Observational
Primary Outcome
Measure Time Frame
Safety (adverse events (AEs), serious AEs (SAEs), adverse drug reactions(ADRs), serious ADRs (SADRs), unexpected AEs/ADRs) For about 1 year since the first dose of the study drug
Secondary Outcome
Measure Time Frame
Progression free survival (PFS) At least 6 months of follow-up
Objective response rate (ORR) At least 3 months of follow-up
Enrollment 600
Condition
Eligibility

Sampling Method: Non-Probability Sample

Criteria:

Inclusion Criteria:

1. Eligible for the study drug treatment according to the approved label in South Korea

2. Provision of signed and dated written informed consent by the patient or legally acceptable representative

Exclusion Criteria:

1. History of hypersensitivity to excipients of the study drug or to drugs with a similar chemical structure or class to the study drug

2. Prior exposure to any Polyadenosine 5'diphosphoribose polymerase (PARP) inhibitors, including the study drug

3. Pregnant and/or breast feeding

4. Current participation in any interventional trial

5. Other off-label indications according to the approved label

Gender: All

Minimum Age: 19 Years

Maximum Age: N/A

Healthy Volunteers: No

Verification Date

September 2020

Responsible Party

Type: Sponsor

Has Expanded Access No
Acronym OLAP
Study Design Info

Observational Model: Cohort

Time Perspective: Prospective

Source: ClinicalTrials.gov