CAPIVASERTIB REGULATORY POSTMARKETING SURVEILLANCE IN KOREA

May 18, 2026 updated by: AstraZeneca
To fulfil the post-approval commitment of MFDS to conduct post-marketing surveillance, this study is designed to assess the known safety profile, identify previously unsuspected adverse reactions and to evaluate the effectiveness of Capivasertib under conditions of routine daily medical practice in Korea.

Study Overview

Status

Recruiting

Conditions

Detailed Description

The objectives of this study are to assess the safety and effectiveness of Capivasertib (hereinafter "the study drug") in a real-world practice setting for patients prescribed with the study drug under the approved local label in South Korea.

Primary Objective To assess the safety of the study drug in patients prescribed with the study drug under the approved label(s) in South Korea

Secondary Objective To assess effectiveness of the study drug in patients prescribed with the study drug under the approved label(s) in South Korea

Study Type

Observational

Enrollment (Estimated)

130

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

  • South Korea
      • Busan, South Korea, 49267
        • Recruiting
        • Research Site
      • Busan, South Korea, 49241
        • Not yet recruiting
        • Research Site
      • Busan, South Korea, 34084
        • Not yet recruiting
        • Research Site
      • Daejeon, South Korea, 35015
        • Recruiting
        • Research Site
      • Daejeon, South Korea, 34943
        • Not yet recruiting
        • Research Site
      • Goyang-si, South Korea, 10408
        • Recruiting
        • Research Site
      • Goyang-si, South Korea, 10380
        • Recruiting
        • Research Site
      • Guri-si, South Korea, 11923
        • Recruiting
        • Research Site
      • Incheon, South Korea, 21565
        • Recruiting
        • Research Site
      • Incheon, South Korea, 22332
        • Recruiting
        • Research Site
      • Seongnam-si, South Korea, 13620
        • Not yet recruiting
        • Research Site
      • Seoul, South Korea, 03722
        • Recruiting
        • Research Site
      • Seoul, South Korea, 06591
        • Recruiting
        • Research Site
      • Seoul, South Korea, 06273
        • Not yet recruiting
        • Research Site
      • Seoul, South Korea, 02841
        • Recruiting
        • Research Site
      • Suwon, South Korea, 16499
        • Recruiting
        • Research Site
      • Uijeongbu-si, South Korea, 11765
        • 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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients currently treated with or initiating the study drug under approved local label and conditions of routine daily medical practice in South Korea will be included in the study. This study will be conducted using a total surveillance method to investigate the safety and effectiveness of all patients being treated with the study drug.

Description

Inclusion Criteria:

  • Patients eligible for and treated with the study drug according to the approved label in South Korea
  • Patients who provide signed and dated written informed consent, either personally or through a legally acceptable representative.

Exclusion Criteria:

  • Participation in any interventional trial during the treatment of the study drug
  • Other off-label indications according to the approved label in South Korea

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse Events (AEs)·Adverse Drug Reactions (ADRs) Serious Adverse Events (SAEs)·Adverse Drug Reactions (SADRs) Unexpected Adverse Events (AEs)·Adverse Drug Reactions (ADRs)
Time Frame: For about 12 months from the first dose of the study drug unless they withdraw consent, are lost to follow-up, experience disease progression, or die. 30 days addtional follow up in case of not completing 12 months.
The safety assessment should include all undesirable changes in medical findings (including clinical test findings) noted during medical visits as required by local practice guidelines, as well as all AEs associated with the study drug administration.
For about 12 months from the first dose of the study drug unless they withdraw consent, are lost to follow-up, experience disease progression, or die. 30 days addtional follow up in case of not completing 12 months.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Real-world progression free survival (rwPFS)
Time Frame: For about 12 months from the first dose of the study drug unless they withdraw consent, are lost to follow-up, experience disease progression, or die
Real-world progression free survival (rwPFS) for patients will be evaluated by routine clinical practice of the investigators. rwPFS will be defined as the time from first dose of the study drug until the date of disease progression or death (by any cause in the absence of progression) regardless of whether the subject withdraws from therapy or receives another anti-cancer therapy prior to progression.Subjects who have not progressed or died at the time of analysis will be censored at the date of their last follow-up assessment.
For about 12 months from the first dose of the study drug unless they withdraw consent, are lost to follow-up, experience disease progression, or die

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)

October 15, 2025

Primary Completion (Estimated)

December 30, 2029

Study Completion (Estimated)

December 30, 2029

Study Registration Dates

First Submitted

April 14, 2025

First Submitted That Met QC Criteria

April 14, 2025

First Posted (Actual)

April 15, 2025

Study Record Updates

Last Update Posted (Actual)

May 19, 2026

Last Update Submitted That Met QC Criteria

May 18, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D3612R00011

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment:

https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

IPD Sharing Time Frame

AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA PhRMA Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

IPD Sharing Access Criteria

When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org.

Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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