Renal Cell CarcinomaNCT03776123
Post-marketing Surveillance on the Safety of CabometyxTM in Korean Patients
An observational study of Renal Cell Carcinoma and Hepatocellular Carcinoma, run by Ipsen at 47 sites in South Korea.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Cell Carcinoma, Hepatocellular Carcinoma, Differentiated Thyroid Carcinoma
- How many people
- 347 participants
- Where
- 47 sitesSouth Korea
- Study dates
- 15 May 2019to 26 Mar 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients administrated Cabometyx™ at the site (Institutions)
Who may be able to join
- 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
Who cannot join
- Patients who are contraindicated for Cabometyx™ based on Cabometyx™ label
Trial locations and contacts
47 sites in 1 country.
47 sites in 1 country
South Korea47 sites
Korea University Ansan Hospital
Ansan, 15355
Hallym University Sacred Heart Hospital
Anyang, 14068
DONG-A University Hospital (Site A)
Busan, 49201
DONG-A University Hospital (Site B)
Busan, 49201
Kyungpook National University Chilgok Hospital
Daegu, 41404
Daegu Catholic University Medical Center
Daegu, 42472
Keimyung University Dongsan Hospital (Site A)
Daegu, 42601
Keimyung University Dongsan Hospital (Site B)
Daegu, 42601
The Catholic University of Korea, Daejeon ST.Mary's Hospital
Daejeon, 34943
Chungnam National University Hospital
Daejeon, 35015
Daejeon Eulji Medical center, Eulji University
Daejeon, 35233
Konyang University Hospital
Daejeon, 35365
The Catholic University of Korea, Uijeongbu ST. Mary's Hospital (site A)
Gyeonggi-do, 11765
The Catholic University of Korea, Uijeongbu ST. Mary's Hospital (Site B)
Gyeonggi-do, 11765
Chonnam National University Hwasun Hospital
Hwasun, 58128
Wonkwang University Hospital
Iksan, 54538
The Catholic University of Korea, St. Mary's Hospital
Incheon, 21431
Gachon University Gil Medical Center
Incheon, 21565
Inha University Hospital
Incheon, 22332
Chungbuk National University Hospital
Jungbuk, 28644
Inje University Busan Paik Hospital
Pusan, 04551
Inje University Haeundae Paik Hospital
Pusan, 48108
Pusan National University Hospital (Site A)
Pusan, 49241
Pusan National University Hospital (Site B)
Pusan, 49241
Kosin University Gospel Hospital (Site A)
Pusan, 49267
Kosin University Gospel Hospital (Site B)
Pusan, 49267
CHA Bundang Medical Center, CHA University
Seongnam, 13496
Inje University Sanggye Paik Hospital (Site A)
Seoul, 01757
Inje University Sanggye Paik Hospital (Site B)
Seoul, 01757
Korea University Anam Hospital (Site A)
Seoul, 02841
Korea University Anam Hospital (Site B)
Seoul, 02841
Severance Hospital, Yonsei University (Site A)
Seoul, 03722
Severance Hospital, Yonsei University (Site B)
Seoul, 03722
Hanyang University Seoul Hospital
Seoul, 04763
Gangdong Kyung Hee University Hospital
Seoul, 05278
Asan Medical Center (Site A)
Seoul, 05505
Asan Medical Center (Site B)
Seoul, 05505
Gangnam Severance Hospital, Yonsei University Health System
Seoul, 06273
Samsung medical center (Site B)
Seoul, 06351
Samsung Medical Center (Site C)
Seoul, 06351
Samsung Medical Center (Site D)
Seoul, 06351
Samsung Medical Centre (Site A)
Seoul, 06351
The Catholic University of Korea, Seoul St. Mary's Hospital
Seoul, 06591
Chung-Ang University Hospital
Seoul, 06973
The Catholic University of Korea, Yeouido St. Mary's Hospital
Seoul, 07345
The Catholic University of Korea, St. Vincent's Hospital
Suwon, 16247
Ulsan University Hospital
Ulsan, 44033
About this study
Official title: 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.
- Medical subject headings
- Carcinoma, Renal Cell, Carcinoma, Hepatocellular
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients experiencing Adverse Events (AEs)/ Serious Adverse Events (SAEs) after Cabometyx™ administration
Measured: 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
Measured: From baseline until 21 days after the last dose of Cabometyx (up to approximately 52 weeks)
Number of AEs/SAEs after Cabometyx™ administration
Measured: From baseline until 21 days after the last dose of Cabometyx (up to approximately 52 weeks)
Secondary outcomes (2)
Objective response rate
Measured: From baseline until 21 days after the last dose of Cabometyx (up to approximately 52 weeks)
Progression Free Survival
Measured: From baseline until 21 days after the last dose of Cabometyx (up to approximately 52 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2018
- Study start15 May 2019
- Primary completion26 Mar 2024
- Study completion26 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by IpsenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 347 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ipsen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ipsen Medical Director, Study director, Ipsen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03776123
- Sponsor's protocol ID
- A-KR-60000-021
- Status last verified
- May 2024
- First submitted
- 10 Dec 2018
- Last updated
- 29 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-marketing Surveillance on the Safety of CabometyxTM in Korean Patients Based on "Guideline for Re-examination of New Drugs"
- ClinicalTrials.gov ID
- NCT03776123
- Acronym / sponsor ID
- A-KR-60000-021
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 347 participants (actual)
- Lead sponsor
- IpsenIndustry (pharma, biotech, devices)
- Study start
- 15 May 2019 (actual)
- Primary completion
- 26 Mar 2024 (actual)
- Study completion
- 26 Mar 2024 (actual)
- First posted
- 14 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients administrated Cabometyx™ at the site (Institutions)
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- Patients who are contraindicated for Cabometyx™ based on Cabometyx™ label
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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)
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)
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)
2 secondary outcomes
Objective response rate
Time frame: 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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2024.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ipsen Medical Director study director
Ipsen
47 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Renal Cell Carcinoma and Hepatocellular Carcinoma, run by Ipsen at 47 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 47 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2024.