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

Hepatocellular Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03776123
• Other study ID #: A-KR-60000-021
• Status: Completed
• Start date: May 15, 2019
• Est. completion date: March 26, 2024

Study information

• Verified date: May 2024
• Source: Ipsen
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 347
• Est. completion date: March 26, 2024
• Est. primary completion date: March 26, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Renal Cell
• Differentiated Thyroid Carcinoma
• Hepatocellular Carcinoma
• Renal Cell Carcinoma
• Thyroid Neoplasms

Locations

Country	Name	City	State
Korea, Republic of	Korea University Ansan Hospital	Ansan
Korea, Republic of	Hallym University Sacred Heart Hospital	Anyang
Korea, Republic of	DONG-A University Hospital (Site A)	Busan
Korea, Republic of	DONG-A University Hospital (Site B)	Busan
Korea, Republic of	Chungbuk National University Hospital	Chungbuk
Korea, Republic of	Daegu Catholic University Medical Center	Daegu
Korea, Republic of	Keimyung University Dongsan Hospital (Site A)	Daegu
Korea, Republic of	Keimyung University Dongsan Hospital (Site B)	Daegu
Korea, Republic of	Kyungpook National University Chilgok Hospital	Daegu
Korea, Republic of	Chungnam National University Hospital	Daejeon
Korea, Republic of	Daejeon Eulji Medical center, Eulji University	Daejeon
Korea, Republic of	Konyang University Hospital	Daejeon
Korea, Republic of	The Catholic University of Korea, Daejeon ST.Mary's Hospital	Daejeon
Korea, Republic of	The Catholic University of Korea, Uijeongbu ST. Mary's Hospital (site A)	Gyeonggi-do
Korea, Republic of	The Catholic University of Korea, Uijeongbu ST. Mary's Hospital (Site B)	Gyeonggi-do
Korea, Republic of	Chonnam National University Hwasun Hospital	Hwasun
Korea, Republic of	Wonkwang University Hospital	Iksan
Korea, Republic of	Gachon University Gil Medical Center	Incheon
Korea, Republic of	Inha University Hospital	Incheon
Korea, Republic of	The Catholic University of Korea, St. Mary's Hospital	Incheon
Korea, Republic of	Inje University Busan Paik Hospital	Pusan
Korea, Republic of	Inje University Haeundae Paik Hospital	Pusan
Korea, Republic of	Kosin University Gospel Hospital (Site A)	Pusan
Korea, Republic of	Kosin University Gospel Hospital (Site B)	Pusan
Korea, Republic of	Pusan National University Hospital (Site A)	Pusan
Korea, Republic of	Pusan National University Hospital (Site B)	Pusan
Korea, Republic of	CHA Bundang Medical Center, CHA University	Seongnam
Korea, Republic of	Asan Medical Center (Site A)	Seoul
Korea, Republic of	Asan Medical Center (Site B)	Seoul
Korea, Republic of	Chung-Ang University Hospital	Seoul
Korea, Republic of	Gangdong Kyung Hee University Hospital	Seoul
Korea, Republic of	Gangnam Severance Hospital, Yonsei University Health System	Seoul
Korea, Republic of	Hanyang University Seoul Hospital	Seoul
Korea, Republic of	Inje University Sanggye Paik Hospital (Site A)	Seoul
Korea, Republic of	Inje University Sanggye Paik Hospital (Site B)	Seoul
Korea, Republic of	Korea University Anam Hospital (Site A)	Seoul
Korea, Republic of	Korea University Anam Hospital (Site B)	Seoul
Korea, Republic of	Samsung medical center (Site B)	Seoul
Korea, Republic of	Samsung Medical Center (Site C)	Seoul
Korea, Republic of	Samsung Medical Center (Site D)	Seoul
Korea, Republic of	Samsung Medical Centre (Site A)	Seoul
Korea, Republic of	Severance Hospital, Yonsei University (Site A)	Seoul
Korea, Republic of	Severance Hospital, Yonsei University (Site B)	Seoul
Korea, Republic of	The Catholic University of Korea, Seoul St. Mary's Hospital	Seoul
Korea, Republic of	The Catholic University of Korea, Yeouido St. Mary's Hospital	Seoul
Korea, Republic of	The Catholic University of Korea, St. Vincent's Hospital	Suwon
Korea, Republic of	Ulsan University Hospital	Ulsan

Sponsors (1)

Lead Sponsor	Collaborator
Ipsen

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients experiencing Adverse Events (AEs)/ Serious Adverse Events (SAEs) after Cabometyx™ administration		From baseline until 21 days after the last dose of Cabometyx (up to approximately 52 weeks)
Primary	Proportion of patients who had AEs/SAE after Cabometyx™ administration		From baseline until 21 days after the last dose of Cabometyx (up to approximately 52 weeks)
Primary	Number of AEs/SAEs after Cabometyx™ administration		From baseline until 21 days after the last dose of Cabometyx (up to approximately 52 weeks)
Secondary	Objective response rate		From baseline until 21 days after the last dose of Cabometyx (up to approximately 52 weeks)
Secondary	Progression Free Survival		From baseline until 21 days after the last dose of Cabometyx (up to approximately 52 weeks)