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'OLAP' (OLAparib Regulatory Post-marketing Surveillance)

Sponsor
AstraZeneca (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04553926
Collaborator
(none)
650
Enrollment
12
Locations
46.9
Anticipated Duration (Months)
54.2
Patients Per Site
1.2
Patients Per Site Per Month

Study Details

Study Description

Brief 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

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Anticipated Enrollment :
    650 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Lynparza Tablet (Olaparib) Regulatory Post-Marketing Surveillance
    Actual Study Start Date :
    Feb 1, 2021
    Anticipated Primary Completion Date :
    Dec 31, 2024
    Anticipated Study Completion Date :
    Dec 31, 2024

    Outcome Measures

    Primary Outcome Measures

    1. 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

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

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    19 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Research Site Busan Korea, Republic of
    2 Research Site Changwon-si Korea, Republic of
    3 Research Site Chungcheongnam-do Korea, Republic of
    4 Research Site Daegu Korea, Republic of
    5 Research Site Daejeon Korea, Republic of
    6 Research Site Gyeonggi-do Korea, Republic of
    7 Research Site Gyeonggi-do Korea, Republic of
    8 Research Site Incheon Korea, Republic of
    9 Research Site Seongnam Korea, Republic of
    10 Research Site Seoul Korea, Republic of
    11 Research Site Seoul Korea, Republic of
    12 Research Site Yangsan Korea, Republic of

    Sponsors and Collaborators

    • AstraZeneca

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    AstraZeneca
    ClinicalTrials.gov Identifier:
    NCT04553926
    Other Study ID Numbers:
    • D0817R00010
    First Posted:
    Sep 18, 2020
    Last Update Posted:
    May 23, 2022
    Last Verified:
    May 1, 2022

    Study Results

    No Results Posted as of May 23, 2022