'OLAP' (OLAparib Regulatory Post-marketing Surveillance)

AstraZeneca661 enrolled

Overview

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

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 Exploratory Objective: To assess effectiveness of the study drug for ovarian cancer patients diagnosed as Homologous Recombination Deficiency (HRD) positive via locally available validated HRD test and prescribed with the study drug under the approved indication in South Korea

Study Type

OBSERVATIONAL

Enrollment

661

Conditions

Ovarian Cancer Breast Cancer Prostate Cancer Pancreatic Cancer

Eligibility

Sex: ALLMin age: 19 YearsMax age: 150 Years

Medical Language ↔ Plain English

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

Locations (18)

Research Site

Ansan, South Korea

Research Site

Bucheon-si, South Korea

Research Site

Busan, South Korea

Outcomes

Primary Outcomes

Safety (adverse events (AEs), serious AEs (SAEs), adverse drug reactions(ADRs), serious ADRs (SADRs), unexpected AEs/ADRs)

Time frame: For about 1 year since the first dose of the study drug

Secondary Outcomes

6-month real-world Progression free survival (rwPFS)

In this PMS, the secondary/pre-specified endpoint is not just PFS, but real-world PFS (rwPFS). That means the sponsor cannot claim investigator/patients to visit hospital for study assessment purposes. We, study sponsor, can only assess and record patient's disease progression status when patients visit hospital for their original follow-up. That's why we need further +50% duration for assessing rwPFS.

Time frame: For about 1 year since the first dose of the study drug

Data from ClinicalTrials.gov

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