'OLAP' (OLAparib Regulatory Post-marketing Surveillance)

AstraZeneca

Status: Completed

Conditions: Breast Cancer; Ovarian Cancer; Prostate Cancer; Pancreatic Cancer

Study type: Observational

Funder types: Industry

Identifiers

NCT04553926

D0817R00010

Details and patient eligibility

About

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

Full 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 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

Enrollment: 661 patients

Sex: All

Ages: 19 to 150 years old

Volunteers: No Healthy Volunteers

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