Post-marketing Surveillance on the Safety of CabometyxTM in Korean Patients
1 other identifier
observational
347
1 country
47
Brief Summary
The objective of this Post Marketing Surveillance (PMS) is to collect and describe safety and effectiveness profile of Cabometyxâ„¢ in real clinical practice setting, according to the approved labelling after the approval of marketing authorization.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started May 2019
Longer than P75 for all trials
47 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 10, 2018
CompletedFirst Posted
Study publicly available on registry
December 14, 2018
CompletedStudy Start
First participant enrolled
May 15, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 26, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
March 26, 2024
CompletedMay 29, 2024
May 1, 2024
4.9 years
December 10, 2018
May 27, 2024
Conditions
Outcome Measures
Primary Outcomes (3)
Number of patients experiencing Adverse Events (AEs)/ Serious Adverse Events (SAEs) after Cabometyxâ„¢ administration
From baseline until 21 days after the last dose of Cabometyx (up to approximately 52 weeks)
Proportion of patients who had AEs/SAE after Cabometyxâ„¢ administration
From baseline until 21 days after the last dose of Cabometyx (up to approximately 52 weeks)
Number of AEs/SAEs after Cabometyxâ„¢ administration
From baseline until 21 days after the last dose of Cabometyx (up to approximately 52 weeks)
Secondary Outcomes (2)
Objective response rate
From baseline until 21 days after the last dose of Cabometyx (up to approximately 52 weeks)
Progression Free Survival
From baseline until 21 days after the last dose of Cabometyx (up to approximately 52 weeks)
Eligibility Criteria
Patients administrated Cabometyxâ„¢ at the site (Institutions)
You may qualify if:
- Patients who meet 'Indications' of label for Cabometyxâ„¢ as monotherapy
- Patients who are treated with Cabometyxâ„¢ for the first time according to label for Cabometyxâ„¢ as monotherapy
- Patients who are aged 18 years or older
- Patients who are willing to provide written consent after being informed of this surveillance
You may not qualify if:
- Patients who are contraindicated for Cabometyxâ„¢ based on Cabometyxâ„¢ label
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Ipsenlead
Study Sites (47)
Korea University Ansan Hospital
Ansan, 15355, South Korea
Hallym University Sacred Heart Hospital
Anyang, 14068, South Korea
DONG-A University Hospital (Site A)
Busan, 49201, South Korea
DONG-A University Hospital (Site B)
Busan, 49201, South Korea
Kyungpook National University Chilgok Hospital
Daegu, 41404, South Korea
Daegu Catholic University Medical Center
Daegu, 42472, South Korea
Keimyung University Dongsan Hospital (Site A)
Daegu, 42601, South Korea
Keimyung University Dongsan Hospital (Site B)
Daegu, 42601, South Korea
The Catholic University of Korea, Daejeon ST.Mary's Hospital
Daejeon, 34943, South Korea
Chungnam National University Hospital
Daejeon, 35015, South Korea
Daejeon Eulji Medical center, Eulji University
Daejeon, 35233, South Korea
Konyang University Hospital
Daejeon, 35365, South Korea
The Catholic University of Korea, Uijeongbu ST. Mary's Hospital (site A)
Gyeonggi-do, 11765, South Korea
The Catholic University of Korea, Uijeongbu ST. Mary's Hospital (Site B)
Gyeonggi-do, 11765, South Korea
Chonnam National University Hwasun Hospital
Hwasun, 58128, South Korea
Wonkwang University Hospital
Iksan, 54538, South Korea
The Catholic University of Korea, St. Mary's Hospital
Incheon, 21431, South Korea
Gachon University Gil Medical Center
Incheon, 21565, South Korea
Inha University Hospital
Incheon, 22332, South Korea
Chungbuk National University Hospital
Jungbuk, 28644, South Korea
Inje University Busan Paik Hospital
Pusan, 04551, South Korea
Inje University Haeundae Paik Hospital
Pusan, 48108, South Korea
Pusan National University Hospital (Site A)
Pusan, 49241, South Korea
Pusan National University Hospital (Site B)
Pusan, 49241, South Korea
Kosin University Gospel Hospital (Site A)
Pusan, 49267, South Korea
Kosin University Gospel Hospital (Site B)
Pusan, 49267, South Korea
CHA Bundang Medical Center, CHA University
Seongnam, 13496, South Korea
Inje University Sanggye Paik Hospital (Site A)
Seoul, 01757, South Korea
Inje University Sanggye Paik Hospital (Site B)
Seoul, 01757, South Korea
Korea University Anam Hospital (Site A)
Seoul, 02841, South Korea
Korea University Anam Hospital (Site B)
Seoul, 02841, South Korea
Severance Hospital, Yonsei University (Site A)
Seoul, 03722, South Korea
Severance Hospital, Yonsei University (Site B)
Seoul, 03722, South Korea
Hanyang University Seoul Hospital
Seoul, 04763, South Korea
Gangdong Kyung Hee University Hospital
Seoul, 05278, South Korea
Asan Medical Center (Site A)
Seoul, 05505, South Korea
Asan Medical Center (Site B)
Seoul, 05505, South Korea
Gangnam Severance Hospital, Yonsei University Health System
Seoul, 06273, South Korea
Samsung medical center (Site B)
Seoul, 06351, South Korea
Samsung Medical Center (Site C)
Seoul, 06351, South Korea
Samsung Medical Center (Site D)
Seoul, 06351, South Korea
Samsung Medical Centre (Site A)
Seoul, 06351, South Korea
The Catholic University of Korea, Seoul St. Mary's Hospital
Seoul, 06591, South Korea
Chung-Ang University Hospital
Seoul, 06973, South Korea
The Catholic University of Korea, Yeouido St. Mary's Hospital
Seoul, 07345, South Korea
The Catholic University of Korea, St. Vincent's Hospital
Suwon, 16247, South Korea
Ulsan University Hospital
Ulsan, 44033, South Korea
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Ipsen Medical Director
Ipsen
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 10, 2018
First Posted
December 14, 2018
Study Start
May 15, 2019
Primary Completion
March 26, 2024
Study Completion
March 26, 2024
Last Updated
May 29, 2024
Record last verified: 2024-05
Data Sharing
- IPD Sharing
- Will share
- Time Frame
- Where applicable, data from eligible studies are available 6 months after the studied medicine and indication have been approved in the US and EU or after the primary manuscript describing the results has been accepted for publication, whichever is later.
- Access Criteria
- Further details on Ipsen's sharing criteria, eligible studies and process for sharing are available here (https://vivli.org/members/ourmembers/).
Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, annotated case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of study participants. Any requests should be submitted to www.vivli.org for assessment by an independent scientific review board.