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Observational Real-life Study of Cabozantinib in Advanced Renal Cell Carcinoma (RCC) (REPLICA)

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: NCT04106349
Recruitment Status : Recruiting
First Posted : September 27, 2019
Last Update Posted : June 26, 2020
Sponsor:
Information provided by (Responsible Party):
Ipsen

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

Condition or disease
Advanced or Metastatic Renal Cell Carcinoma

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Study Type : Observational
Estimated Enrollment : 150 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: REPLICA: Real Patient Life Treatment With Cabozantinib in Patients With Advanced or Metastatic RCC: A Descriptive and Prospective Non-Interventional Study
Actual Study Start Date : March 3, 2020
Estimated Primary Completion Date : January 30, 2023
Estimated Study Completion Date : May 31, 2024


Group/Cohort
1st line
2nd line
later lines



Primary Outcome Measures :
  1. Treatment line [ Time Frame: Baseline ]
    Treatment line will be assessed at baseline. It is a percentage of patients receiving cabozantinib as 1st, 2nd or later lines of treatment.

  2. Dose reductions and reasons [ Time Frame: From baseline up to 6 to 8 weeks after cabozantinib initiation and within 10 days of cabozantinib stop ]
    Number of dose reductions and reason

  3. Treatment interruptions and reason [ Time Frame: From baseline up to 6 to 8 weeks after cabozantinib initiation and within 10 days of cabozantinib stop ]
    Number of treatment interruptions and reason

  4. Treatment discontinuations and reason [ Time Frame: From baseline up to 6 to 8 weeks after cabozantinib initiation and within 10 days of cabozantinib stop ]
    Number of patients with permanent discontinuation and reason

  5. Alternative dose schedule [ Time Frame: From baseline until the end of study up to 9 months ]
    Number of patients with schedules other than 1 pill at fixed dose/day for the total treatment period

  6. Mean number of any dose modification [ Time Frame: From baseline up to 6 to 8 weeks after cabozantinib initiation and within 10 days of cabozantinib stop ]
  7. Median number of any dose modification [ Time Frame: From baseline up to 6 to 8 weeks after cabozantinib initiation and within 10 days of cabozantinib stop ]
  8. Median time to any first dose modification [ Time Frame: From baseline up to 6 to 8 weeks after cabozantinib initiation and within 10 days of cabozantinib stop ]
  9. Median time to end of treatment [ Time Frame: From baseline until the end of study up to 9 months ]
  10. Duration of treatment exposure [ Time Frame: From baseline until the end of study up to 9 months ]
  11. Dose prescribed at initiation [ Time Frame: Baseline ]
    Number of patients with dose of 60 mg/day, 40 mg/day or 20 mg/day at baseline

  12. Average daily dose [ Time Frame: From baseline until the end of study up to 9 months ]
    Estimation of average daily dose received by subject during the treatment exposure


Secondary Outcome Measures :
  1. Change in Quality of Life score [ Time Frame: From baseline up to 6 to 8 weeks after cabozantinib initiation and within 10 days of cabozantinib stop ]
    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.

  2. Progression Free Survival (PFS) [ Time Frame: From baseline until the end of study up to 9 months ]
    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

  3. Objective Response Rate [ Time Frame: From baseline until the end of study up to 9 months ]
    Percent of patients with partial and complete response during the treatment with cabozantinib

  4. Disease Control Rate [ Time Frame: From baseline until the end of study up to 9 months ]
    Percent of patients with stable disease, partial and complete response during the treatment with cabozantinib



Information from the National Library of Medicine

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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
advanced or metastatic renal cell carcinoma
Criteria

Inclusion Criteria:

  • Males or females aged 18 years and older
  • Patients scheduled to receive Cabometyx® for advanced or metastatic renal cell carcinoma
  • Decision to treat patients with Cabometyx® has to be taken prior to and independent from participation in the clinical study
  • Provision of written informed consent

Exclusion Criteria:

  • Participation in another clinical study at the same time
  • Previous participation in this clinical study

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): NCT04106349


Contacts
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Contact: Ipsen Recruitment Enquiries clinical.trials@ipsen.com

Locations
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Belgium
Onze-Lieve-vrouw Ziekenhuis Aalst Recruiting
Aalst, Belgium, 9300
Vivalia Hôpital d'Arlon Not yet recruiting
Arlon, Belgium, 6700
AZ Sint-Jan Brugge Recruiting
Brugge, Belgium, 8000
Ziekenhuis Oost-Limburg Genk Recruiting
Genk, Belgium, 3600
Universitair Ziekenhuis Gent Recruiting
Gent, Belgium, 9000
CHR Citadelle Liège Recruiting
Liège, Belgium, 4000
CHU Liège / Sart-Tilman Recruiting
Liège, Belgium, 4000
Hôpital Ambroise-Paré Mons Recruiting
Mons, Belgium, 7000
AZ Turnhout Recruiting
Turnhout, Belgium, 2300
UCL Namur - site Godinne Not yet recruiting
Yvoir, Belgium, 5530
Sponsors and Collaborators
Ipsen
Investigators
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Study Director: Ipsen Medical Director Ipsen
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Responsible Party: Ipsen
ClinicalTrials.gov Identifier: NCT04106349    
Other Study ID Numbers: A-BE-60000-047
2019-001102-18 ( EudraCT Number )
First Posted: September 27, 2019    Key Record Dates
Last Update Posted: June 26, 2020
Last Verified: June 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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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