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

Completed

• Conditions: Hepatocellular Carcinoma; Differentiated Thyroid Carcinoma; Renal Cell Carcinoma

• Registration Number: NCT03776123
• Lead Sponsor: Ipsen

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-12-10
• Study First Submitted QC: 2018-12-13
• Study First Posted: 2018-12-14
• Study Start: 2019-05-15
• Primary Completion: 2024-03-26
• Study Completion: 2024-03-26
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-27
• Last Update Posted: 2024-05-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 347

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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)
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)
Number of AEs/SAEs after Cabometyx™ administration	From baseline until 21 days after the last dose of Cabometyx (up to approximately 52 weeks)

Secondary Outcome Measures

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

Trial Locations

Locations (47)

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

Kyungpook National University Chilgok Hospital; 🇰🇷 Daegu, 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

The Catholic University of Korea, Daejeon ST.Mary's Hospital; 🇰🇷 Daejeon, Korea, Republic of

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