A Study to Collect Pre-existing Data on the Administration of Cabozantinib in Participants With Advanced Renal Cell Carcinoma (aRCC) Who Initiated Cabozantinib in 2nd Line in a Real-life Clinical Setting in France. (OCTOPUS)

July 17, 2023 updated by: Ipsen

OCTOPUS: An Observational, Non-interventional, Non-comparative, Retrospective, Multicentre Study in Patients With Advanced Renal Cell Carcinoma (aRCC) Who Initiated Cabozantinib in 2nd Line Under Real-life Setting in France.

Cabozantinib is an orally bioavailable tyrosine kinase inhibitor (TKI) approved in patients with aRCC previously treated with a Vascular Endothelial Growth Factor (VEGF)-targeted therapy. Cabozantinib has been increasingly used in routine care in second line and more in advanced or metastatic RCC in France.

Cabozantinib effectiveness and safety notably in a real-word setting are now well known, but too many questions that arise during the routine care of patients with aRCC remain unanswered by the current literature.

Obtaining data on cabozantinib effectiveness and treatment pattern in those participants subpopulations will allow physicians to improve patients care.

The aims of this study are to describe the effectiveness - in terms of Duration of Treatment (DOT), Best Overall Response (BOR) and Progression-Free Survival (PFS) - and the safety of second line cabozantinib a real-life setting in France and to address the unanswered questions that arise during the routine care of patients with aRCC treated with cabozantinib in order to improve the care of these participants.

Study Overview

Status

Completed

Conditions

Detailed Description

Since 2018, cabozantinib has been increasingly used in routine care in second line and more in advanced or metastatic RCC in France.

Cabozantinib effectiveness and safety notably in a real-word setting are now well known, but too many questions that arise during the routine care of patients with aRCC remain unanswered by the current literature.

As an example, there is currently no real-world data on cabozantinib in elderly patients (≥ 75 years old); in patients with a systemic therapy after progression under cabozantinib (only one published monocentric retrospective study on 56 participants); or in long responder patients (with a disease controlled after > 12 months of cabozantinib). Obtaining data on cabozantinib effectiveness and treatment pattern in those patient subpopulations will allow physicians to improve patients care.

Study Type

Observational

Enrollment (Actual)

252

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Amiens, France
        • CHU Amiens
      • Angers, France
        • CHU Angers
      • Avignon, France
        • Institut Sainte Catherine
      • Besançon, France
        • CHU Besancon
      • Bordeaux, France
        • CHU Bordeaux
      • Brest, France
        • CHRU BREST
      • Cabestany, France
        • Centre Chirurgie Urinaire et d'Andrologie
      • Clermont-Ferrand, France
        • Chu Clermont-Ferrand
      • Créteil, France
        • APHP (Créteil)
      • Grenoble, France
        • CHU Grenoble
      • Lille, France
        • CHU Lille
      • Limoges, France
        • CHU Limoges
      • Lyon, France
        • Centre Leon Berard
      • Lyon, France
        • Hôpital Edouard Herriot
      • Nancy, France
        • Polyclinique de Gentilly
      • Nice, France
        • CHU Nice
      • Paris, France
        • Institut mutualiste Montsouris
      • Paris, France, 75013
        • APHP
      • Paris, France, 75014
        • APHP
      • Paris, France, 75015
        • APHP (Paris Grenelle)
      • Pierre-Bénite, France
        • Hospices Civils De Lyon
      • Quimper, France
        • CH Quimper
      • Reims, France
        • CHU Reims
      • Suresnes, France
        • Hopital FOCH
      • Toulouse, France
        • Oncopole Chu Toulouse
      • Tours, France
        • CHRU Tours
      • Villejuif, France
        • Institut Gustave Roussy
      • Épagny, France
        • Centre Hospitalier Annecy-Genevois

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

An estimated total of 300 participants with aRCC and who started cabozantinib in 2nd line between 1st March 2018 and 1st March 2021 is planned to be included. Participants will be enrolled from approximately 25 centers in France

Description

Inclusion Criteria:

  • Male or female ≥ 18 age at the time of cabozantinib initiation.
  • Pathologically confirmed diagnosis of Renal Cell Carcinoma (RCC) considered as advanced at the time of cabozantinib initiation.
  • Cabozantinib initiated from 1st March 2018 to 1st March 2021 for an advanced RCC.
  • Cabozantinib initiated in 2nd line according to local Summary of Product Characteristics (SmPC).

Exclusion Criteria:

  • Participant medical file without documented follow-up visits (post-cabozantinib initiation).
  • Participant alive at study initiation who is opposed to data collection.
  • Participant who died before study initiation and who was opposed to data collection for research purposes when alive.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Sequencing post-cabozantinib
Participants treated by cabozantinib and who received another systemic therapy post-cabozantinib.
Long responders
Participants treated by cabozantinib and who had a disease controlled (CR, PR or SDi during > 12 months after cabozantinib initiation with or without additional local treatment).
Non-responders
Participants treated by cabozantinib and who had a progressive disease less than 3 months after cabozantinib treatment initiation.
Cabozantinib & rechallenge
Participants treated by cabozantinib who received systemic therapy and/or had prolonged treatment-free interval (≥ 12 weeks) between two cabozantinib treatment periods. Participants with at least one cabozantinib rechallenge could be included in this subgroup.
Cabozantinib & therapeutic schedules
Participants treated by cabozantinib and who needed 1/ a dose increase following disease progression and/or a prior reduction, Or 2/ had any dose reduction/dose interruption of cabozantinib (schedule adaptation).
Cabozantinib & local treatment
Participants treated by cabozantinib and who needed concomitant local treatment (LT) by surgery or radiotherapy
Cabozantinib & elderly patients
Participants treated by cabozantinib and aged ≥ 75 years

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Duration of treatment (DOT) of cabozantinib
Time Frame: From baseline up to 18 months
Defined as the time between first and last intake of cabozantinib treatment, regardless of the treatment discontinuation reason.
From baseline up to 18 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Best Overall Response (BOR), until disease progression/recurrence
Time Frame: From baseline up to 18 months
Defined as the proportion of participants achieving the best response among Complete Response (CR), Partial Response (PR), Stable Disease (SDi) or Disease Progression (DP), The method used for the assessment of response to treatment will be left at the discretion of the physician
From baseline up to 18 months
Progression Free Survival (PFS).
Time Frame: From baseline up to 18 months
Defined as the time from the date of first cabozantinib intake to the date of first documented progression reported by the investigator or death from any cause. Disease progression will be assessed by tumour response evaluation according to investigator assessment.
From baseline up to 18 months
Incidence of all adverse events (AEs).
Time Frame: From baseline up to 30 days after cabozantinib last intake
Whether they are serious/non-serious, related/unrelated experienced by the participants during cabozantinib treatment period(s).
From baseline up to 30 days after cabozantinib last intake
Incidence of all Special Situations.
Time Frame: From baseline up to 30 days after cabozantinib last intake
Whether they are serious/non-serious, related/unrelated experienced by the participants
From baseline up to 30 days after cabozantinib last intake
Type of subsequent therapy
Time Frame: From baseline up to 18 months
Will be described in terms of type, other TKI, Immuno-Oncology therapy (IO), mammalian Target Of Rapamycin (mTOR) inhibitors, other
From baseline up to 18 months
DOT of subsequent therapy
Time Frame: From baseline up to 18 months
From baseline up to 18 months
Starting dose of subsequent therapy
Time Frame: From baseline up to 18 months
From baseline up to 18 months
Reasons for cabozantinib discontinuation
Time Frame: From baseline up to 18 months
From baseline up to 18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ipsen

Investigators

  • Study Director: Ipsen Medical Director, Ipsen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 16, 2022

Primary Completion (Actual)

May 12, 2023

Study Completion (Actual)

May 12, 2023

Study Registration Dates

First Submitted

June 30, 2022

First Submitted That Met QC Criteria

June 30, 2022

First Posted (Actual)

July 6, 2022

Study Record Updates

Last Update Posted (Actual)

July 18, 2023

Last Update Submitted That Met QC Criteria

July 17, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CLIN-60000-454

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, annotated case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of study participants.

Any requests should be submitted to www.vivli.org for assessment by an independent scientific review board.

IPD Sharing Time Frame

Where applicable, data from eligible studies are available 6 months after the studied medicine and indication have been approved in the US and EU or after the primary manuscript describing the results has been accepted for publication, whichever is later.

IPD Sharing Access Criteria

Further details on Ipsen's sharing criteria, eligible studies and process for sharing are available here (https://vivli.org/members/ourmembers/).

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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