Post-marketing Surveillance on the Safety of CabometyxTM in Korean Patients

March 27, 2024 updated by: Ipsen

Post-marketing Surveillance on the Safety of CabometyxTM in Korean Patients Based on "Guideline for Re-examination of New Drugs"

The objective of this Post Marketing Surveillance (PMS) is to collect and describe safety and effectiveness profile of Cabometyx™ in real clinical practice setting, according to the approved labelling after the approval of marketing authorization.

Study Overview

Status

Active, not recruiting

Conditions

Study Type

Observational

Enrollment (Actual)

347

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

  • Korea, Republic of
      • Ansan, Korea, Republic of, 15355
        • Korea University Ansan Hospital
      • Anyang, Korea, Republic of, 14068
        • Hallym University Sacred Heart Hospital
      • Busan, Korea, Republic of, 49201
        • DONG-A University Hospital (Site A)
      • Busan, Korea, Republic of, 49201
        • DONG-A University Hospital (Site B)
      • Chungbuk, Korea, Republic of, 28644
        • Chungbuk National University Hospital
      • Daegu, Korea, Republic of, 41404
        • Kyungpook National University Chilgok Hospital
      • Daegu, Korea, Republic of, 42472
        • Daegu Catholic University Medical Center
      • Daegu, Korea, Republic of, 42601
        • Keimyung University Dongsan Hospital (Site A)
      • Daegu, Korea, Republic of, 42601
        • Keimyung University Dongsan Hospital (Site B)
      • Daejeon, Korea, Republic of, 35015
        • Chungnam National University Hospital
      • Daejeon, Korea, Republic of, 35365
        • Konyang University Hospital
      • Daejeon, Korea, Republic of, 35233
        • Daejeon Eulji Medical Center, Eulji University
      • Daejeon, Korea, Republic of, 34943
        • The Catholic University of Korea, Daejeon ST.Mary's Hospital
      • Gyeonggi-do, Korea, Republic of, 11765
        • The Catholic University of Korea, Uijeongbu ST. Mary's Hospital (site A)
      • Gyeonggi-do, Korea, Republic of, 11765
        • The Catholic University of Korea, Uijeongbu ST. Mary's Hospital (Site B)
      • Hwasun, Korea, Republic of, 58128
        • Chonnam National University Hwasun Hospital
      • Iksan, Korea, Republic of, 54538
        • Wonkwang University Hospital
      • Incheon, Korea, Republic of, 21565
        • Gachon University Gil Medical Center
      • Incheon, Korea, Republic of, 22332
        • Inha University Hospital
      • Incheon, Korea, Republic of, 21431
        • The Catholic University of Korea, St. Mary's Hospital
      • Pusan, Korea, Republic of, 04551
        • Inje University Busan Paik Hospital
      • Pusan, Korea, Republic of, 48108
        • Inje University Haeundae Paik Hospital
      • Pusan, Korea, Republic of, 49241
        • Pusan National University Hospital (Site A)
      • Pusan, Korea, Republic of, 49241
        • Pusan National University Hospital (Site B)
      • Pusan, Korea, Republic of, 49267
        • Kosin University Gospel Hospital (Site A)
      • Pusan, Korea, Republic of, 49267
        • Kosin University Gospel Hospital (Site B)
      • Seongnam, Korea, Republic of, 13496
        • CHA Bundang Medical Center, CHA University
      • Seoul, Korea, Republic of, 06591
        • The Catholic University of Korea, Seoul St. Mary's Hospital
      • Seoul, Korea, Republic of, 06973
        • Chung-Ang University Hospital
      • Seoul, Korea, Republic of, 04763
        • Hanyang University Seoul Hospital
      • Seoul, Korea, Republic of, 06273
        • Gangnam Severance Hospital, Yonsei University Health System
      • Seoul, Korea, Republic of, 07345
        • The Catholic University of Korea, Yeouido St. Mary's Hospital
      • Seoul, Korea, Republic of, 05278
        • Gangdong Kyung Hee University Hospital
      • Seoul, Korea, Republic of, 01757
        • Inje University Sanggye Paik Hospital (Site A)
      • Seoul, Korea, Republic of, 01757
        • Inje University Sanggye Paik Hospital (Site B)
      • Seoul, Korea, Republic of, 02841
        • Korea University Anam Hospital (Site A)
      • Seoul, Korea, Republic of, 02841
        • Korea University Anam Hospital (Site B)
      • Seoul, Korea, Republic of, 03722
        • Severance Hospital, Yonsei University (Site A)
      • Seoul, Korea, Republic of, 03722
        • Severance Hospital, Yonsei University (Site B)
      • Seoul, Korea, Republic of, 05505
        • Asan Medical Center (Site A)
      • Seoul, Korea, Republic of, 05505
        • Asan Medical Center (Site B)
      • Seoul, Korea, Republic of, 06351
        • Samsung medical center (Site B)
      • Seoul, Korea, Republic of, 06351
        • Samsung Medical Center (Site C)
      • Seoul, Korea, Republic of, 06351
        • Samsung Medical Center (Site D)
      • Seoul, Korea, Republic of, 06351
        • Samsung Medical Centre (Site A)
      • Suwon, Korea, Republic of, 16247
        • The Catholic university of Korea, St. Vincent's Hospital
      • Ulsan, Korea, Republic of, 44033
        • Ulsan University Hospital

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients administrated Cabometyx™ at the site (Institutions)

Description

Inclusion Criteria:

  • Patients who meet 'Indications' of label for Cabometyx™ as monotherapy
  • Patients who are treated with Cabometyx™ for the first time according to label for Cabometyx™ as monotherapy
  • Patients who are aged 18 years or older
  • Patients who are willing to provide written consent after being informed of this surveillance

Exclusion Criteria:

  • Patients who are contraindicated for Cabometyx™ based on Cabometyx™ label

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of patients experiencing Adverse Events (AEs)/ Serious Adverse Events (SAEs) after Cabometyx™ administration
Time Frame: From baseline until 21 days after the last dose of Cabometyx (up to approximately 52 weeks)
From baseline until 21 days after the last dose of Cabometyx (up to approximately 52 weeks)
Proportion of patients who had AEs/SAE after Cabometyx™ administration
Time Frame: From baseline until 21 days after the last dose of Cabometyx (up to approximately 52 weeks)
From baseline until 21 days after the last dose of Cabometyx (up to approximately 52 weeks)
Number of AEs/SAEs after Cabometyx™ administration
Time Frame: From baseline until 21 days after the last dose of Cabometyx (up to approximately 52 weeks)
From baseline until 21 days after the last dose of Cabometyx (up to approximately 52 weeks)

Secondary Outcome Measures

Outcome Measure
Time Frame
Objective response rate
Time Frame: From baseline until 21 days after the last dose of Cabometyx (up to approximately 52 weeks)
From baseline until 21 days after the last dose of Cabometyx (up to approximately 52 weeks)
Progression Free Survival
Time Frame: From baseline until 21 days after the last dose of Cabometyx (up to approximately 52 weeks)
From baseline until 21 days after the last dose of Cabometyx (up to approximately 52 weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ipsen

Investigators

  • Study Director: Ipsen Medical Director, Ipsen

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)

May 15, 2019

Primary Completion (Estimated)

March 26, 2024

Study Completion (Estimated)

March 26, 2024

Study Registration Dates

First Submitted

December 10, 2018

First Submitted That Met QC Criteria

December 13, 2018

First Posted (Actual)

December 14, 2018

Study Record Updates

Last Update Posted (Actual)

March 28, 2024

Last Update Submitted That Met QC Criteria

March 27, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A-KR-60000-021

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing 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.

IPD Sharing Access Criteria

Further details on Ipsen's sharing criteria, eligible studies and process for sharing are available here (https://vivli.org/members/ourmembers/).

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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