CAPIVASERTIB REGULATORY POSTMARKETING SURVEILLANCE IN KOREA
1 other identifier
observational
130
1 country
17
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Oct 2025
Longer than P75 for all trials
17 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 14, 2025
CompletedFirst Posted
Study publicly available on registry
April 15, 2025
CompletedStudy Start
First participant enrolled
October 15, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 30, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 30, 2029
April 21, 2026
April 1, 2026
4.2 years
April 14, 2025
April 16, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Adverse Events (AEs)·Adverse Drug Reactions (ADRs) Serious Adverse Events (SAEs)·Adverse Drug Reactions (SADRs) Unexpected Adverse Events (AEs)·Adverse Drug Reactions (ADRs)
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 Outcomes (1)
Real-world progression free survival (rwPFS)
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
Eligibility Criteria
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.
You may qualify if:
- 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.
You may not qualify if:
- Participation in any interventional trial during the treatment of the study drug
- Other off-label indications according to the approved label in South Korea
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (17)
Research Site
Busan, 34084, South Korea
Research Site
Busan, 49241, South Korea
Research Site
Busan, 49267, South Korea
Research Site
Daejeon, 34943, South Korea
Research Site
Daejeon, 35015, South Korea
Research Site
Goyang-si, 10380, South Korea
Research Site
Goyang-si, 10408, South Korea
Research Site
Guri-si, 11923, South Korea
Research Site
Incheon, 21565, South Korea
Research Site
Incheon, 22332, South Korea
Research Site
Seongnam-si, 13620, South Korea
Research Site
Seoul, 02841, South Korea
Research Site
Seoul, 03722, South Korea
Research Site
Seoul, 06273, South Korea
Research Site
Seoul, 06591, South Korea
Research Site
Suwon, 16499, South Korea
Research Site
Uijeongbu-si, 11765, South Korea
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
AstraZeneca Clinical Study Information Center
CONTACT
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 14, 2025
First Posted
April 15, 2025
Study Start
October 15, 2025
Primary Completion (Estimated)
December 30, 2029
Study Completion (Estimated)
December 30, 2029
Last Updated
April 21, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
- 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.
- 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.
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.