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Study of Cabozantinib in Patients With Advanced or Metastatic Renal Cell Carcinoma Under Real-life Clinical Setting in 1st Line Treatment. (CABOCARE)

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ClinicalTrials.gov Identifier: NCT03647878
Recruitment Status : Recruiting
First Posted : August 27, 2018
Last Update Posted : August 28, 2020
Sponsor:
Information provided by (Responsible Party):
Ipsen

Tracking Information
First Submitted Date July 25, 2018
First Posted Date August 27, 2018
Last Update Posted Date August 28, 2020
Actual Study Start Date September 24, 2018
Estimated Primary Completion Date August 30, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: August 24, 2018)
  • The proportion of subjects with dose reduction due to Serious Adverse Events/Adverse Events (SAEs/AEs) [ Time Frame: 2 years ]
    The proportion of subjects with ≥1 dose reduction due to AE will be described with its 95% confidence interval, by risk group and overall.
  • The proportion of subjects with dose interruption due to SAEs/AEs [ Time Frame: 2 years ]
    The proportion of subjects with ≥1 dose interruption due to AE will be described with its 95% confidence interval, by risk group and overall.
  • The proportion of subjects with termination of Cabozantinib due to SAEs/AEs [ Time Frame: 2 years ]
    The proportion of subjects with ≥1 discontinuation due to AE will be described with its 95% confidence interval, by risk group and overall.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: August 24, 2018)
  • Progression free survival (PFS) [ Time Frame: 2 years ]
    Progression free survival is defined as the time between the start date of cabozantinib and the date of progression or death from any cause. Disease progression is defined as either radiological progression assessed by the investigator using RECIST 1.1 or clinical progression.
  • Best overall response - Overall Response Rate (ORR) [ Time Frame: 2 years ]
    The best overall response is the best response assessed by investigator recorded during the treatment period. ORR is defined as the proportion of subjects achieving complete or partial response.
  • Best overall response - Disease Control Rate (DCR) [ Time Frame: 2 years ]
    The best overall response is the best response assessed by investigator recorded during the treatment period. DCR is defined as the proportion of subjects achieving a complete response, partial response or stable disease.
  • All non-serious and serious adverse events (AEs / SAEs) and fatal outcomes [ Time Frame: 2 years ]
    Safety: clinical parameter, as routinely assessed by the investigator, as well as occurrence of all serious and non-serious AEs as well as fatal outcomes and special situations. The adverse events will be described overall and also according to level of physical activity assessed by questionnaire and actigraph.
  • Impact of the activity level at baseline on the occurrence of adverse events (AEs) [ Time Frame: 2 years ]
    Safety: clinical parameter, as routinely assessed by the investigator, as well as occurrence of all serious and non-serious AEs as well as fatal outcomes and special situations; data of activity level and quality of life will be collected using the quality of life questionnaire (NFKSI-19 questionnaire) and the activity questionnaire; inflammatory blood markers, as routinely assessed by the investigator, will be captured.
  • The proportion of subjects with termination due to SAEs/AEs in sub-group [ Time Frame: 2 year ]
    The proportion of subjects with ≥1 termination due to AE will be described with its 95% confidence interval, by risk group and overall split by histological subtype (clear cell and non-clear cell).
  • The proportion of subjects with dose interruption due to SAEs/AEs in sub-group [ Time Frame: 2 year ]
    The proportion of subjects with ≥1 dose interruption due to AE will be described with its 95% confidence interval, by risk group and overall split by histological subtype (clear cell and non-clear cell).
  • The proportion of subjects with dose reduction due to SAEs/AEs in sub-group [ Time Frame: 2 years ]
    The proportion of subjects with ≥1 dose reduction due to AE will be described with its 95% confidence interval, by risk group and overall split by histological subtype (clear cell and non-clear cell).
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Study of Cabozantinib in Patients With Advanced or Metastatic Renal Cell Carcinoma Under Real-life Clinical Setting in 1st Line Treatment.
Official Title Prospective Non-interventional Study of Cabozantinib in Patients With Advanced or Metastatic Renal Cell Carcinoma Under Real-life Clinical Setting in 1st Line Treatment
Brief Summary The purpose of the protocol, is to describe the use of CabometyxTM (cabozantinib) tablets including the number of dose reductions, dose interruptions and terminations due to (serious) adverse events in subjects with advanced or metastatic renal cell carcinoma (mRCC) treated in real-life clinical setting in 1st line treatment.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients treated with Cabozantinib in advanced or metastatic renal cell carcinoma in 1st line treatment
Condition Advanced or Metastatic Renal Cell Carcinoma
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: August 24, 2018)
105
Original Estimated Enrollment Same as current
Estimated Study Completion Date August 30, 2022
Estimated Primary Completion Date August 30, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Males or females aged 18 years and older with capacity to consent.
  • Subjects receiving cabozantinib as a first line treatment for advanced or metastatic renal cell carcinoma
  • Subjects with the intention to be treated with cabozantinib tablets according to the current local Summary of Product Characteristics (SmPC) (Germany, Austria); decision has to be taken before entry in the study.
  • Signed written informed consent

Exclusion Criteria:

  • Participation in an interventional study at the same time and/or within 3 months before baseline.
  • Previous participation in this study
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Ipsen Recruitment Enquiries clinical.trials@ipsen.com
Listed Location Countries Austria,   Germany
Removed Location Countries  
 
Administrative Information
NCT Number NCT03647878
Other Study ID Numbers A-DE-60000-009
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party Ipsen
Study Sponsor Ipsen
Collaborators Not Provided
Investigators
Study Director: Ipsen Medical Director Ipsen
PRS Account Ipsen
Verification Date August 2020