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OpenTrials
Completed

NCT Number: NCT03776123

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

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.

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Key information

Conditions

Renal Cell Carcinoma Adenocarcinoma Carcinoma Carcinoma, Hepatocellular Carcinoma, Renal Cell Differentiated Thyroid Carcinoma Digestive System Diseases Digestive System Neoplasms Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Hepatocellular Carcinoma Kidney Diseases Kidney Neoplasms Liver Diseases Liver Neoplasms Male Urogenital Diseases Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Korea University Ansan Hospital, Ansan, South Korea

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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)

  2. 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)

  3. 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)

Secondary outcomes

  1. Objective response rate

    Time frame: From baseline until 21 days after the last dose of Cabometyx (up to approximately 52 weeks)

  2. Progression Free Survival

    Time frame: From baseline until 21 days after the last dose of Cabometyx (up to approximately 52 weeks)

Sponsors and collaborators

Lead sponsor

Ipsen

Industry

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2024
Study completion
2024
First posted
Dec 14, 2018
Registry last updated
May 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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