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'OLAP' (OLAparib Regulatory P...

'OLAP' (OLAparib Regulatory Post-marketing Surveillance)

Last Updated: 2025-08-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

661 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-02-01

Study Completion Date

2025-07-11

Brief Summary

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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

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Detailed Description

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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

Conditions

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Ovarian Cancer Breast Cancer Prostate Cancer Pancreatic Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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

Minimum Eligible Age

19 Years

Maximum Eligible Age

150 Years

Eligible Sex

ALL

Accepts Healthy Volunteers