NCT03744585

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
450

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2018

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 6, 2018

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

November 14, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 16, 2018

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 7, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 7, 2019

Completed
Last Updated

July 26, 2019

Status Verified

July 1, 2019

Enrollment Period

7 months

First QC Date

November 14, 2018

Last Update Submit

July 24, 2019

Conditions

Renal Cell Carcinoma

Outcome Measures

Primary Outcomes (7)

  • Duration of treatment exposure

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

  • Dose prescribed at initiation

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

  • Average Daily Dose

    average daily dose received by subject during the treatment exposure

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

  • Number of subjects with ≥1 temporary interruptions

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

  • Number of interruptions per subject

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

  • Number of subjects with ≥1 dose modification(s)

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

  • Number of subjects with permanent discontinuations

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

Secondary Outcomes (3)

  • Overall survival of subjects since cabozantinib initiation

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

  • Overall survival of subjects since RCC diagnosis.

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

  • Overall survival of subjects since metastatic diagnosis

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

Study Arms (2)

Cohort 1

Subjects who received at least one dose of cabozantinib during the Authorization for Use (ATU) period (12/09/2016 to 09/12/2016) for the treatment of advanced Renal Cell Carcinoma (RCC).

Cohort 2

Subjects who received at least one dose of cabozantinib during the first six months after the ATU period (10/12/2016 to 16/02/2018).

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Cohort 1: subjects who received at least one dose of cabozantinib during the ATU period (12/09/2016 to 09/12/2016) for the treatment of advanced RCC. Cohort 2: subjects who received at least one dose of cabozantinib during the first six months after the ATU period (10/12/2016 to 16/02/2018).

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ipsen Central Contact

Paris, France

Location

Related Publications (1)

  • Albiges L, Flechon A, Chevreau C, Topart D, Gravis G, Oudard S, Tourani JM, Geoffrois L, Meriaux E, Thiery-Vuillemin A, Barthelemy P, Ladoire S, Laguerre B, Perrot V, Billard A, Escudier B, Gross-Goupil M. Real-world evidence of cabozantinib in patients with metastatic renal cell carcinoma: Results from the CABOREAL Early Access Program. Eur J Cancer. 2021 Jan;142:102-111. doi: 10.1016/j.ejca.2020.09.030. Epub 2020 Nov 27.

    PMID: 33253997DERIVED

MeSH Terms

Conditions

Carcinoma, Renal Cell

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsKidney NeoplasmsUrologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesKidney DiseasesUrologic DiseasesMale Urogenital Diseases

Study Officials

  • Ipsen Medical Director

    Ipsen

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 14, 2018

First Posted

November 16, 2018

Study Start

November 6, 2018

Primary Completion

June 7, 2019

Study Completion

July 7, 2019

Last Updated

July 26, 2019

Record last verified: 2019-07

Locations

FR(1)