'OLAP' (OLAparib Regulatory Post-marketing Surveillance) (OLAP)

Lynparza Tablet (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

Study Overview

• Status: Completed
• Conditions: Breast Cancer; Pancreatic Cancer; Ovarian Cancer; Prostate Cancer

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

• Study Type: Observational
• Enrollment (Actual): 661

Contacts and Locations

Study Locations

• South Korea
  • Ansan, South Korea
    • Research Site
  • Bucheon-si, South Korea
    • Research Site
  • Busan, South Korea
    • Research Site
  • Changwon, South Korea
    • Research Site
  • Daegu, South Korea
    • Research Site
  • Daejeon, South Korea
    • Research Site
  • Goyang, South Korea
    • Research Site
  • Gunpo, South Korea
    • Research Site
  • Hwaseong, South Korea
    • Research Site
  • Ilsan, South Korea
    • Research Site
  • Incheon, South Korea
    • Research Site
  • Jeonju, South Korea
    • Research Site
  • Seongnam, South Korea
    • Research Site
  • Seoul, South Korea
    • Research Site
  • Suwon, South Korea
    • Research Site
  • Uijeongbu-si, South Korea
    • Research Site
  • Yangsan, South Korea
    • Research Site
  • Yongin, South Korea
    • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 150 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

On active study drug treatment according to the approved local label.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome 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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	For about 1 year since the first dose of the study drug

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
1-year real-world Progression free survival (rwPFS)	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.	For about 18 months since the first dose of the study drug

Collaborators and Investigators

• Sponsor: AstraZeneca

Publications and helpful links

Helpful Links

• Redacted CSR synopsis

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2021
• Primary Completion (Actual): July 11, 2025
• Study Completion (Actual): July 11, 2025

Study Registration Dates

• First Submitted: September 10, 2020
• First Submitted That Met QC Criteria: September 17, 2020
• First Posted (Actual): September 18, 2020

Study Record Updates

• Last Update Posted (Actual): July 23, 2026
• Last Update Submitted That Met QC Criteria: July 22, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Endocrine System Diseases; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Prostatic Diseases; Male Urogenital Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Digestive System Neoplasms; Digestive System Diseases; Genital Diseases, Female; Endocrine Gland Neoplasms; Pancreatic Diseases; Ovarian Diseases; Adnexal Diseases; Genital Neoplasms, Female; Gonadal Disorders; Skin Diseases; Breast Diseases; Skin and Connective Tissue Diseases; Prostatic Neoplasms; Ovarian Neoplasms; Breast Neoplasms; Pancreatic Neoplasms
• Other Study ID Numbers: D0817R00010