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Completed

NCT Number: NCT04553926

'OLAP' (OLAparib Regulatory Post-marketing Surveillance)

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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Key information

Conditions

Ovarian Cancer Adnexal Diseases Breast Cancer Breast Diseases Breast Neoplasms Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Diseases, Male Genital Neoplasms, Female Genital Neoplasms, Male Gonadal Disorders Male Urogenital Diseases Neoplasms Neoplasms by Site Ovarian Diseases Ovarian Neoplasms Pancreatic Cancer Pancreatic Diseases Pancreatic Neoplasms Prostate Cancer Prostatic Diseases Prostatic Neoplasms Skin Diseases Skin and Connective Tissue Diseases Urogenital Diseases Urogenital Neoplasms

Age range

19 year–150 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Research Site, Ansan, South Korea

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Eligible for the study drug treatment according to the approved label in South Korea
  • Provision of signed and dated written informed consent by the patient or legally acceptable representative

Exclusion criteria

  • History of hypersensitivity to excipients of the study drug or to drugs with a similar chemical structure or class to the study drug
  • Prior exposure to any Polyadenosine 5'diphosphoribose polymerase (PARP) inhibitors, including the study drug
  • Pregnant and/or breast feeding
  • Current participation in any interventional trial
  • Other off-label indications according to the approved label

Treatment and study plan

Primary outcomes

  1. 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

  1. 6-month real-world Progression free survival (rwPFS)

    Time frame: 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.

Other outcomes

  1. 1-year real-world Progression free survival (rwPFS)

    Time frame: For about 18 months since the first dose of the study drug

    for the exploratory objective, "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.

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

Lynparza Tablet (Olaparib) Regulatory Post-Marketing Surveillance

Acronym: OLAP

Important dates

Study start
2021
Primary completion
2025
Study completion
2025
First posted
Sep 18, 2020
Registry last updated
Jul 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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