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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04106349
Other study ID # A-BE-60000-047
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date March 3, 2020
Est. completion date June 30, 2026

Study information

Verified date May 2024
Source Ipsen
Contact Ipsen Recruitment Enquiries
Phone see email
Email clinical.trials@ipsen.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The purpose of this study is to describe the real-life use of Cabometyx® in monotherapy or in combination with nivolumab in Belgium in patients with advanced or metastatic Renal Cell Carcinoma (1st, 2nd and later lines of treatment)


Recruitment information / eligibility

Status Recruiting
Enrollment 150
Est. completion date June 30, 2026
Est. primary completion date December 31, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Males or females aged 18 years and older - Patients scheduled to receive Cabometyx® in monotherapy or in combination with nivolumabfor advanced or metastatic renal cell carcinoma - Decision to treat patients with Cabometyx® in monotherapy or in combination with nivolumab has to be taken prior to and independent from participation in the clinical study - Provision of written informed consent Exclusion Criteria: - Participation in another interventional clinical study at the same time - Previous participation in this clinical study

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Belgium Onze-Lieve-vrouw Ziekenhuis Aalst Aalst
Belgium Vivalia Hôpital d'Arlon Arlon
Belgium Imeldaziekenhuis Bonheiden
Belgium Clinique Saint-Luc Bouge Bouge
Belgium AZ Sint-Jan Brugge Brugge
Belgium AZ Sint-Lucas Brugge
Belgium Chirec Delta Brussels
Belgium Hôpital Erasme Brussels
Belgium UZ Brussel Brussels
Belgium Ziekenhuis Oost-Limburg Genk Genk
Belgium Universitair Ziekenhuis Gent Gent
Belgium Virga Jessa Ziekenhuis Hasselt
Belgium Hôpital de Jolimont La Louvière
Belgium CHC MontLegia Liège
Belgium CHR Citadelle Liège Liège
Belgium CHU Liège / Sart-Tilman Liège
Belgium Hôpital Ambroise-Paré Mons Mons
Belgium CHU Charleroi - site André Vésale Montigny-le-Tilleul
Belgium Clinique Saint-Pierre Ottignies
Belgium AZ Delta Roeselare
Belgium AZ Glorieux Ronse
Belgium CHWAPI Tournai
Belgium AZ Turnhout Turnhout
Belgium CHR Verviers Verviers
Belgium UCL Namur - site Godinne Yvoir

Sponsors (1)

Lead Sponsor Collaborator
Ipsen

Country where clinical trial is conducted

Belgium, 

Outcome

Type Measure Description Time frame Safety issue
Primary Treatment line Treatment line will be assessed at baseline. It is a percentage of patients receiving cabozantinib as 1st, 2nd or later lines of treatment or cabozantinib in monotherapy or in combination with nivolumab as 1st line of treatment. Baseline
Primary Dose reductions and reasons Number of dose reductions and reason From baseline up to 6 to 8 weeks after cabozantinib initiation and within 10 days of cabozantinib stop
Primary Treatment interruptions and reason Number of treatment interruptions and reason From baseline up to 6 to 8 weeks after cabozantinib initiation and within 10 days of cabozantinib stop
Primary Treatment discontinuations and reason Number of patients with permanent discontinuation and reason From baseline up to 6 to 8 weeks after cabozantinib initiation and within 10 days of cabozantinib stop
Primary Alternative dose schedule Number of patients with schedules other than 1 pill at fixed dose/day for the total treatment period From baseline until the end of study up to 9 months
Primary Mean number of any dose modification From baseline up to 6 to 8 weeks after cabozantinib initiation and within 10 days of cabozantinib stop
Primary Median number of any dose modification From baseline up to 6 to 8 weeks after cabozantinib initiation and within 10 days of cabozantinib stop
Primary Median time to any first dose modification From baseline up to 6 to 8 weeks after cabozantinib initiation and within 10 days of cabozantinib stop
Primary Median time to end of treatment From baseline until the end of study up to 9 months
Primary Duration of treatment exposure From baseline until the end of study up to 9 months
Primary Dose prescribed at initiation Number of patients with dose of 60 mg/day, 40 mg/day or 20 mg/day at baseline Baseline
Primary Average daily dose Estimation of average daily dose received by subject during the treatment exposure From baseline until the end of study up to 9 months
Secondary Change in Quality of Life score Changes in quality of life data by comparing changes in scores on Using the National Comprehensive Cancer Network/Functional Assessment of Cancer Therapy Kidney Symptom Index-19 (NFKSI-19). It describes the severity, interference, and frequency rates. From baseline up to 6 to 8 weeks after cabozantinib initiation and within 10 days of cabozantinib stop
Secondary Progression Free Survival (PFS) Radiological progression using RECIST 1.1 or investigator assessed or according to local standard of care or death; PFS evaluated at least every 12 weeks under treatment with cabozantinib From baseline until the end of study up to 9 months
Secondary Objective Response Rate Percent of patients with partial and complete response during the treatment with cabozantinib From baseline until the end of study up to 9 months
Secondary Disease Control Rate Percent of patients with stable disease, partial and complete response during the treatment with cabozantinib From baseline until the end of study up to 9 months
See also
  Status Clinical Trial Phase
Active, not recruiting NCT04043975 - A Study of Nivolumab Plus Ipilimumab in Participants With Renal Cell Cancer in the Real World Setting in Japan
Completed NCT00873210 - Study In Patients With Kidney Cancer Treated With Sutent N/A