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Trial record 5 of 5 for:    TIVOZANIB | Renal Cancer | Italy

Non-interventional Study of Cabozantinib in Adults With Advanced Renal Cell Carcinoma (CASSIOPE)

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ClinicalTrials.gov Identifier: NCT03419572
Recruitment Status : Recruiting
First Posted : February 5, 2018
Last Update Posted : February 24, 2021
Sponsor:
Information provided by (Responsible Party):
Ipsen

Brief Summary:
The objective of this study is to understand the utilization of cabozantinib in subjects with advanced renal cell carcinoma (RCC) following prior VEGF-targeted therapy in real life settings in terms of dose modifications due to adverse events (AEs) when used as a second line therapy or third and later line therapy. Other patterns of use of cabozantinib will also be described.

Condition or disease Intervention/treatment
Renal Cell Carcinoma Other: Data collection

Detailed Description:
The study will follow the real-life management of patients in clinical practice. Visits will take place according to the study site's clinical practice. Cabozantinib is to be administered as directed by the investigator according to the study site's usual clinical practice and the Cabometyx™ Summary of Product Characteristics (SmPC).

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Study Type : Observational
Estimated Enrollment : 680 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective Non Interventional Study of Cabozantinib Tablets in Adults With Advanced Renal Cell Carcinoma Following Prior Vascular Endothelial Growth Factor (VEGF)-Targeted Therapy
Actual Study Start Date : April 24, 2018
Estimated Primary Completion Date : April 30, 2021
Estimated Study Completion Date : April 30, 2021


Group/Cohort Intervention/treatment
Second line therapy
Data collection
Other: Data collection
Only available evaluations as decided by the investigator based on local clinical practice will be collected.

Third and later line therapy
Data collection
Other: Data collection
Only available evaluations as decided by the investigator based on local clinical practice will be collected.




Primary Outcome Measures :
  1. The proportion of subjects with dose modifications due to AEs [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. Reason for cabozantinib dose modification (any modification, reduction, temporary interruption or discontinuation) [ Time Frame: 12 months ]
    Percentage of subjects with the following reasons - Disease progression, Adverse event, Subject non-compliance, Treatment resumed or re escalated, Subject decision, Clinical / investigator decision, Other

  2. Description of number of cabozantinib dose modifications (any modification, reduction, temporary interruption, increase or discontinuation) [ Time Frame: 12 months ]
  3. Median time to first cabozantinib dose modification (any modification, reduction, temporary interruption, increase or discontinuation) due to AEs and for any reason [ Time Frame: 12 months ]
  4. Description of cabozantinib starting dose (combination of dose per intake and frequency) [ Time Frame: 12 months ]
  5. Description of daily dose of cabozantinib received [ Time Frame: 12 months ]
  6. Description of cabozantinib dose intensity (average daily dose compared to starting dose) [ Time Frame: 12 months ]
  7. Duration of cabozantinib treatment (expressed as mean and median time to end of treatment) [ Time Frame: 12 months ]
  8. Proportion of subjects with concomitant radiotherapies [ Time Frame: 12 months ]
  9. Description of systemic therapy (drug name) planned following cabozantinib discontinuation [ Time Frame: 12 months ]
    Percentage of subjects treated with the following drugs: Sunitinib, Pazopanib, Axitinib, Sorafenib, Bevacizumab, Cytokines, Everolimus, Lenvatinib, Nivolumab, Tivozanib, Experimental trial drug, Other, Unknown)

  10. Overall best response [ Time Frame: 12 months ]
    Per investigator assessment

  11. Median Progression Free Survival (PFS) time [ Time Frame: 12 months ]
    Defined as the time between the start date of cabozantinib and the date of progression or death. Clinical and radiographic (assessed by the investigator based on RECIST 1.1)

  12. Overall Survival (OS) rate at the end of the study [ Time Frame: 12 months ]
  13. Health care resource utilisation: number of visits to health care professionals (hospitalisation, surgical procedure, emergency room, physician, homecare by nurse) associated with the management of treatment-related AEs [ Time Frame: 12 months ]
  14. Health care resource utilisation: Description of concomitant medications (by drug class and preferred name) associated with the management of treatment-related AEs [ Time Frame: 12 months ]
  15. Health care resource utilisation: Description of number of unplanned laboratory tests associated with the management of treatment-related AEs [ Time Frame: 12 months ]

Other Outcome Measures:
  1. Incidence of all treatment-emergent non-serious and serious AEs [ Time Frame: 12 months ]


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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
Subjects with advanced RCC following prior VEGF-targeted therapy in real life settings.
Criteria

Inclusion Criteria:

  • Age ≥18 years old
  • Has a diagnosis of advanced RCC
  • Has received at least one prior VEGF-targeted therapy
  • For whom the treating physician has decided to start treatment with cabozantinib tablets prior to inclusion
  • No previous exposure to cabozantinib prior to inclusion
  • Not concurrently involved in an interventional study
  • Consents to participate in this noninterventional study

Exclusion Criteria:

  • There are no exclusion criteria for this 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): NCT03419572


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

Locations
Show Show 108 study locations
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: NCT03419572    
Other Study ID Numbers: F-FR-60000-001
EUPAS19464 ( Registry Identifier: EU PAS Register )
First Posted: February 5, 2018    Key Record Dates
Last Update Posted: February 24, 2021
Last Verified: February 2021

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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, Renal Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Carcinoma
Adenocarcinoma
Urologic Diseases