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A Non-interventional Retrospective Study to Describe Early Clinical Experience With Cabozantinib in Patients With Advanced Renal Cell Carcinoma (RCC) in the UK

NCT ID: NCT03696407

Last Updated: 2020-11-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

108 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-12-20

Study Completion Date

2019-08-01

Brief Summary

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Clinical experience with cabozantinib is limited in the UK and Ireland and there is anecdotal evidence of there being variability between clinicians in terms of where cabozantinib is used in the treatment pathway. The present study aims to collate and report the experiences of a sample of National Health Service (NHS) Trusts that enrolled patients onto the managed access programme. The study will describe the positioning of cabozantinib in the treatment pathway, associated clinical outcomes and characteristics of patients with advanced RCC receiving cabozantinib in this early clinical experience setting. The results will provide valuable information for collective learning on how to prescribe and manage cabozantinib and its optimal positioning in the patient pathway. Overall, the findings will contribute to a better understanding of how best to manage patients with advanced RCC in routine practice.

Detailed Description

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Conditions

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Advanced Renal Cell Carcinoma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* A diagnosis of advanced RCC
* Prescribed cabozantinib as part of the Managed Access Programme (MAP) (alive or deceased at study data collection)
* Aged ≥18 years at start of cabozantinib treatment.

Exclusion Criteria

* Decline or lack the capacity to consent for researcher access to their medical records (if living)
* Hospital medical records are unavailable for review
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ipsen

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ipsen Medical Director

Role: STUDY_DIRECTOR

Ipsen

Locations

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Royal Sussex County Hospital

Brighton, , United Kingdom

Site Status

Addenbrooke's Hospital

Cambridge, , United Kingdom

Site Status

Beatson West of Scotland Cancer Centre

Glasgow, , United Kingdom

Site Status

Royal Surrey County Hospital

Guildford, , United Kingdom

Site Status

St Bartholomew's Hospital

London, , United Kingdom

Site Status

The Christie Hospital

Manchester, , United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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A-GB-60000-017

Identifier Type: -

Identifier Source: org_study_id