Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Post Marketing Surveillance to Observe Safety and Effectiveness of CABOMETYX™ in Korea.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03776123
Recruitment Status : Recruiting
First Posted : December 14, 2018
Last Update Posted : June 1, 2020
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease
Renal Cell Carcinoma

Layout table for study information
Study Type : Observational
Estimated Enrollment : 422 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective, Post Marketing Surveillance to Observe Safety and Effectiveness of CABOMETYX™ Under the Real Practice Setting in Patients With Renal Cell Carcinoma in Korea.
Actual Study Start Date : May 15, 2019
Estimated Primary Completion Date : February 28, 2022
Estimated Study Completion Date : May 31, 2022





Primary Outcome Measures :
  1. Number of patients experiencing Adverse Events (AEs)/ Serious Adverse Events (SAEs) after Cabometyx™ administration [ Time Frame: Week 0-52 ]
  2. Proportion of patients who had AEs/SAE after Cabometyx™ administration [ Time Frame: Week 0-52 ]
  3. Number of AEs/SAEs after Cabometyx™ administration [ Time Frame: Week 0-52 ]

Secondary Outcome Measures :
  1. Objective response rate [ Time Frame: Week 0-52 ]
  2. Progression Free Survival [ Time Frame: Week 0-52 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients administrated Cabometyx™ at the site (Institutions)
Criteria

Inclusion Criteria:

  • Patients who meet 'Indications' of Cabometyx™ label
  • Patients who are treated with Cabometyx™ for the first time according to Cabometyx™ label
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03776123


Contacts
Layout table for location contacts
Contact: Ipsen Recruitment Enquiries clinical.trials@ipsen.com

Locations
Show Show 27 study locations
Sponsors and Collaborators
Ipsen
Investigators
Layout table for investigator information
Study Director: Ipsen Medical Director Ipsen
Layout table for additonal information
Responsible Party: Ipsen
ClinicalTrials.gov Identifier: NCT03776123    
Other Study ID Numbers: A-KR-60000-021
First Posted: December 14, 2018    Key Record Dates
Last Update Posted: June 1, 2020
Last Verified: May 2020

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Carcinoma
Carcinoma, Renal Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases