'OLAP' (OLAparib Regulatory Post-marketing Surveillance)

Lynparza Tablet (Olaparib) Regulatory Post-Marketing Surveillance

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04553926

Acronym

OLAP

Enrollment

661

Registered

2020-09-18

Start date

2021-02-01

Completion date

2025-07-11

Last updated

2026-07-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer, Ovarian Cancer, Pancreatic Cancer, Prostate Cancer

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 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

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

19 Years to 150 Years

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

Design outcomes

Primary

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

Measure	Time frame	Description
6-month real-world Progression free survival (rwPFS)	For about 1 year since the first dose of the study drug	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.

Countries

South Korea

Outcome results