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Completed

NCT Number: NCT03744585

Cabozantinib Real-life Use for Advanced Renal Cell Carcinoma in France: a Retrospective Descriptive Non-interventional Study of 2 Cohorts.

The primary objective of the study is to describe the real-life conditions of use and exposure of cabozantinib in France in two cohorts defined by their treatment initiation period.

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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

Sex eligibility

All sexes

Study type

Observational

Primary location

Ipsen Central Contact

Paris, France

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Any subjects from the participating sites (dead or alive) who have received at least one dose of cabozantinib within the ATU program or between 10/12/2016 and 16/02/2018 and for whom the medical file is available

Exclusion criteria

  • Patients alive at study initiation who have not received information notice
  • who have opposed to data collection.

Treatment and study plan

Primary outcomes

  1. Duration of treatment exposure

    Time frame: during the whole study period for a maximum of 28 to 31 months

  2. Dose prescribed at initiation

    Time frame: during the whole study period for a maximum of 28 to 31 months

  3. Average Daily Dose

    Time frame: during the whole study period for a maximum of 28 to 31 months

    average daily dose received by subject during the treatment exposure

  4. Number of subjects with ≥1 temporary interruptions

    Time frame: during the whole study period for a maximum of 28 to 31 months

  5. Number of interruptions per subject

    Time frame: during the whole study period for a maximum of 28 to 31 months

  6. Number of subjects with ≥1 dose modification(s)

    Time frame: during the whole study period for a maximum of 28 to 31 months

  7. Number of subjects with permanent discontinuations

    Time frame: during the whole study period for a maximum of 28 to 31 months

Secondary outcomes

  1. Overall survival of subjects since cabozantinib initiation

    Time frame: during the whole study period for a maximum of 28 to 31 months

  2. Overall survival of subjects since RCC diagnosis.

    Time frame: during the whole study period for a maximum of 28 to 31 months

  3. Overall survival of subjects since metastatic diagnosis

    Time frame: during the whole study period for a maximum of 28 to 31 months

Sponsors and collaborators

Lead sponsor

Ipsen

Industry

Registry information

Acronym: CABOREAL

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Nov 16, 2018
Registry last updated
Jul 26, 2019

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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