'OLAP' (OLAparib Regulatory Post-marketing Surveillance)

Last updated: May 28, 2025
Sponsor: AstraZeneca
Overall Status: Active - Recruiting

Phase

N/A

Condition

Prostate Cancer

Ovarian Cancer

Pancreatic Cancer

Treatment

N/A

Clinical Study ID

NCT04553926
D0817R00010
  • Ages 19-150
  • All Genders

Study 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

Eligibility Criteria

Inclusion

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 legallyacceptable representative

Exclusion

Exclusion Criteria:

  1. History of hypersensitivity to excipients of the study drug or to drugs with asimilar 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 Design

Total Participants: 600
Study Start date:
February 01, 2021
Estimated Completion Date:
August 31, 2025

Study 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

Connect with a study center

  • Research Site

    Busan,
    Korea, Republic of

    Active - Recruiting

  • Research Site

    Changwon-si,
    Korea, Republic of

    Site Not Available

  • Research Site

    Cheongju, 28644
    Korea, Republic of

    Site Not Available

  • Research Site

    Chungcheongnam-do,
    Korea, Republic of

    Site Not Available

  • Research Site

    Daegu, 42415
    Korea, Republic of

    Site Not Available

  • Research Site

    Daejeon,
    Korea, Republic of

    Active - Recruiting

  • Research Site

    Goyang, 10408
    Korea, Republic of

    Site Not Available

  • Research Site

    Gunpo,
    Korea, Republic of

    Active - Recruiting

  • Research Site

    Gyeonggi-do,
    Korea, Republic of

    Site Not Available

  • Research Site

    Hwaseong,
    Korea, Republic of

    Active - Recruiting

  • Research Site

    Ilsan,
    Korea, Republic of

    Active - Recruiting

  • Research Site

    Incheon, 21565
    Korea, Republic of

    Site Not Available

  • Research Site

    Seongnam, 13496
    Korea, Republic of

    Site Not Available

  • Research Site

    Seoul,
    Korea, Republic of

    Active - Recruiting

  • Research Site

    Seul,
    Korea, Republic of

    Active - Recruiting

  • Research Site

    Suwon,
    Korea, Republic of

    Active - Recruiting

  • Research Site

    Uijeongbu, 11765
    Korea, Republic of

    Site Not Available

  • Research Site

    Yangsan, 50612
    Korea, Republic of

    Site Not Available

  • Research Site

    Yongin,
    Korea, Republic of

    Active - Recruiting

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