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NCT Number: NCT03419572

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Kepler University Hospital - Urology, Linz, Austria

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About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Data Collection

Other

Only available evaluations as decided by the investigator based on local clinical practice will be collected.

Primary outcomes

  1. The proportion of subjects with dose modifications due to AEs

    Time frame: 12 months

Secondary outcomes

  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 outcomes

  1. Incidence of all treatment-emergent non-serious and serious AEs

    Time frame: 12 months

Sponsors and collaborators

Lead sponsor

Ipsen

Industry

Registry information

Official study title

Prospective Non Interventional Study of Cabozantinib Tablets in Adults With Advanced Renal Cell Carcinoma Following Prior Vascular Endothelial Growth Factor (VEGF)-Targeted Therapy

Acronym: CASSIOPE

Important dates

Study start
2018
Primary completion
2022
Study completion
2022
First posted
Feb 5, 2018
Registry last updated
Aug 15, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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