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

April 22, 2024 updated by: AstraZeneca

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

Recruiting

Conditions

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 (Estimated)

650

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Korea, Republic of
      • Busan, Korea, Republic of, 48108
        • Recruiting
        • Research Site
      • Busan, Korea, Republic of, 47392
        • Recruiting
        • Research Site
      • Busan, Korea, Republic of, 49267
        • Recruiting
        • Research Site
      • Busan, Korea, Republic of, 50615
        • Recruiting
        • Research Site
      • Cheongju, Korea, Republic of
        • Not yet recruiting
        • Research Site
      • Cheongju, Korea, Republic of, 28644
        • Recruiting
        • Research Site
      • Daegu, Korea, Republic of, 42415
        • Recruiting
        • Research Site
      • Daejeon, Korea, Republic of, 35365
        • Recruiting
        • Research Site
      • Goyang, Korea, Republic of, 10408
        • Recruiting
        • Research Site
      • Incheon, Korea, Republic of, 21565
        • Recruiting
        • Research Site
      • Seongnam, Korea, Republic of, 13620
        • Not yet recruiting
        • Research Site
      • Seongnam, Korea, Republic of, 13620
        • Recruiting
        • Research Site
      • Seongnam, Korea, Republic of, 13496
        • Not yet recruiting
        • Research Site
      • Seoul, Korea, Republic of, 03722
        • Recruiting
        • Research Site
      • Seoul, Korea, Republic of, 05030
        • Recruiting
        • Research Site
      • Seoul, Korea, Republic of
        • Not yet recruiting
        • Research Site
      • Seoul, Korea, Republic of, 06351
        • Not yet recruiting
        • Research Site
      • Seoul, Korea, Republic of, 03722
        • Not yet recruiting
        • Research Site
      • Seoul, Korea, Republic of, 06273
        • Not yet recruiting
        • Research Site
      • Seoul, Korea, Republic of, 04763
        • Not yet recruiting
        • Research Site
      • Seoul, Korea, Republic of, ,02841
        • Recruiting
        • Research Site
      • Seoul, Korea, Republic of, 04401
        • Recruiting
        • Research Site
      • Seoul, Korea, Republic of, 14577
        • Recruiting
        • Research Site
      • Suwon, Korea, Republic of, 16247
        • Not yet recruiting
        • Research Site
      • Uijeongbu, Korea, Republic of, 11765
        • Recruiting
        • Research Site
      • Yangsan, Korea, Republic of, 50612
        • Recruiting
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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)
Time Frame: For about 1 year since the first dose of the study drug
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)
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.
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)
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.
For about 18 months since the first dose of the study drug

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2021

Primary Completion (Estimated)

June 30, 2025

Study Completion (Estimated)

June 30, 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)

April 23, 2024

Last Update Submitted That Met QC Criteria

April 22, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • D0817R00010

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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