Clinical trial NCT03776123: Post-marketing Surveillance on the Safety of CabometyxTM in Korean Patients
Official title: Post-marketing Surveillance on the Safety of CabometyxTM in Korean Patients Based on "Guideline for Re-examination of New Drugs"
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Renal Cell Carcinoma
Hepatocellular Carcinoma
Differentiated Thyroid Carcinoma
Lead sponsor: Ipsen
Sponsor class: INDUSTRY
First posted: 2018-12-14
Enrollment: 347
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients administrated Cabometyx™ at the site (Institutions)

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Number of patients experiencing Adverse Events (AEs)/ Serious Adverse Events (SAEs) after Cabometyx™ administration
timeFrame: From baseline until 21 days after the last dose of Cabometyx (up to approximately 52 weeks)
measure: Proportion of patients who had AEs/SAE after Cabometyx™ administration
timeFrame: From baseline until 21 days after the last dose of Cabometyx (up to approximately 52 weeks)
measure: Number of AEs/SAEs after Cabometyx™ administration
timeFrame: From baseline until 21 days after the last dose of Cabometyx (up to approximately 52 weeks)
Secondary outcomes:
measure: Objective response rate
timeFrame: From baseline until 21 days after the last dose of Cabometyx (up to approximately 52 weeks)
measure: Progression Free Survival
timeFrame: From baseline until 21 days after the last dose of Cabometyx (up to approximately 52 weeks)
Other outcomes:
Locations:
city: Ansan
country: Korea, Republic of
facility: Korea University Ansan Hospital
city: Anyang
country: Korea, Republic of
facility: Hallym University Sacred Heart Hospital
city: Busan
country: Korea, Republic of
facility: DONG-A University Hospital (Site A)
city: Busan
country: Korea, Republic of
facility: DONG-A University Hospital (Site B)
city: Chungbuk
country: Korea, Republic of
facility: Chungbuk National University Hospital
city: Daegu
country: Korea, Republic of
facility: Kyungpook National University Chilgok Hospital
city: Daegu
country: Korea, Republic of
facility: Daegu Catholic University Medical Center
city: Daegu
country: Korea, Republic of
facility: Keimyung University Dongsan Hospital (Site A)
city: Daegu
country: Korea, Republic of
facility: Keimyung University Dongsan Hospital (Site B)
city: Daejeon
country: Korea, Republic of
facility: The Catholic University of Korea, Daejeon ST.Mary's Hospital
city: Daejeon
country: Korea, Republic of
facility: Chungnam National University Hospital
city: Daejeon
country: Korea, Republic of
facility: Daejeon Eulji Medical center, Eulji University
city: Daejeon
country: Korea, Republic of
facility: Konyang University Hospital
city: Gyeonggi-do
country: Korea, Republic of
facility: The Catholic University of Korea, Uijeongbu ST. Mary's Hospital (site A)
city: Gyeonggi-do
country: Korea, Republic of
facility: The Catholic University of Korea, Uijeongbu ST. Mary's Hospital (Site B)
city: Hwasun
country: Korea, Republic of
facility: Chonnam National University Hwasun Hospital
city: Iksan
country: Korea, Republic of
facility: Wonkwang University Hospital
city: Incheon
country: Korea, Republic of
facility: The Catholic University of Korea, St. Mary's Hospital
city: Incheon
country: Korea, Republic of
facility: Gachon University Gil Medical Center
city: Incheon
country: Korea, Republic of
facility: Inha University Hospital
city: Pusan
country: Korea, Republic of
facility: Inje University Busan Paik Hospital
city: Pusan
country: Korea, Republic of
facility: Inje University Haeundae Paik Hospital
city: Pusan
country: Korea, Republic of
facility: Pusan National University Hospital (Site A)
city: Pusan
country: Korea, Republic of
facility: Pusan National University Hospital (Site B)
city: Pusan
country: Korea, Republic of
facility: Kosin University Gospel Hospital (Site A)
city: Pusan
country: Korea, Republic of
facility: Kosin University Gospel Hospital (Site B)
city: Seongnam
country: Korea, Republic of
facility: CHA Bundang Medical Center, CHA University
city: Seoul
country: Korea, Republic of
facility: Inje University Sanggye Paik Hospital (Site A)
city: Seoul
country: Korea, Republic of
facility: Inje University Sanggye Paik Hospital (Site B)
city: Seoul
country: Korea, Republic of
facility: Korea University Anam Hospital (Site A)
city: Seoul
country: Korea, Republic of
facility: Korea University Anam Hospital (Site B)
city: Seoul
country: Korea, Republic of
facility: Severance Hospital, Yonsei University (Site A)
city: Seoul
country: Korea, Republic of
facility: Severance Hospital, Yonsei University (Site B)
city: Seoul
country: Korea, Republic of
facility: Hanyang University Seoul Hospital
city: Seoul
country: Korea, Republic of
facility: Gangdong Kyung Hee University Hospital
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center (Site A)
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center (Site B)
city: Seoul
country: Korea, Republic of
facility: Gangnam Severance Hospital, Yonsei University Health System
city: Seoul
country: Korea, Republic of
facility: Samsung medical center (Site B)
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center (Site C)
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center (Site D)
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Centre (Site A)
city: Seoul
country: Korea, Republic of
facility: The Catholic University of Korea, Seoul St. Mary's Hospital
city: Seoul
country: Korea, Republic of
facility: Chung-Ang University Hospital
city: Seoul
country: Korea, Republic of
facility: The Catholic University of Korea, Yeouido St. Mary's Hospital
city: Suwon
country: Korea, Republic of
facility: The Catholic University of Korea, St. Vincent's Hospital
city: Ulsan
country: Korea, Republic of
facility: Ulsan University Hospital
Study officials:
affiliation: Ipsen
name: Ipsen Medical Director
role: STUDY_DIRECTOR
References: