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

Advanced Renal Cell Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03696407
• Other study ID #: A-GB-60000-017
• Status: Completed
• Start date: December 20, 2018
• Est. completion date: August 1, 2019

Study information

• Verified date: November 2020
• Source: Ipsen
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 108
• Est. completion date: August 1, 2019
• Est. primary completion date: August 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Advanced Renal Cell Carcinoma
• Carcinoma
• Carcinoma, Renal Cell

Locations

Country	Name	City	State
United Kingdom	Royal Sussex County Hospital	Brighton
United Kingdom	Addenbrooke's Hospital	Cambridge
United Kingdom	Beatson West of Scotland Cancer Centre	Glasgow
United Kingdom	Royal Surrey County Hospital	Guildford
United Kingdom	St Bartholomew's Hospital	London
United Kingdom	The Christie Hospital	Manchester

Sponsors (1)

Lead Sponsor	Collaborator
Ipsen

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Positioning of cabozantinib in the treatment pathway	Positioning of cabozantinib in the treatment pathway (second line, third line, fourth line or above)	24 months
Primary	Distribution of cabozantinib starting dose.	Distribution, mean (SD) and median (quartiles) cabozantinib starting dose.	Baseline
Primary	Daily dose during treatment	Mean (SD) and median (quartiles) cabozantinib daily dose during treatment.	24 months
Primary	Proportion of patients with dose modifications	Proportion of patients with dose modifications and mean (SD) and median (quartiles) number of dose modifications per patient.	24 months
Primary	Median time to first dose modification		24 months
Primary	Distribution of reasons for dose modifications.		24 months
Primary	Proportion of patients permanently discontinuing cabozantinib.		24 months
Primary	Distribution of reasons for discontinuation of treatment		24 months
Primary	Median duration of cabozantinib treatment (months)		24 months
Primary	Distribution of relevant concomitant treatments	Radiation procedures, denosumab, bisphosphonates.	24 months
Primary	Distribution of systemic therapies prescribed for advanced RCC after discontinuation of cabozantinib.		24 months
Secondary	Distribution of RCC stage and histological type at initial RCC diagnosis		baseline
Secondary	Time (months) from advanced RCC diagnosis to cabozantinib initiation.	Mean (SD) and median (quartiles) time (months	baseline
Secondary	Distribution of RCC stage at cabozantinib initiation.		baseline
Secondary	Distribution of metastatic sites.	Metastatic sites (lung / liver / bone / lymph node / brain / visceral other) documented co-morbidities and distribution of relevant co-morbidities.	baseline
Secondary	Distribution of International Metastatic Renal Cell Carcinoma Database Consortium (IMDC) risk group	Distribution of IMDC risk group (favourable, intermediate, poor). From patient's medical records (if documented) or calculated from the individual components (haemoglobin, Karnofsky Performance Status, time from advanced RCC diagnosis to systemic treatment initiation, calcium, neutrophils, platelets).	baseline
Secondary	Progression Free Survival (PFS)	PFS is defined as the time from cabozantinib initiation until the date of first documented evidence of disease progression or death from any cause. Disease progression is defined as either radiological disease progression (according to RECIST criteria [if documented in routine practice] or other local investigator assessment]) or clinical progression	3, 6, 9, 12, 18 and 24 months and median PFS.
Secondary	Overall Survival (OS)	OS will be measured from both cabozantinib initiation (time from cabozantinib initiation until death from any cause) and from advanced RCC diagnosis (from advanced RCC diagnosis until death from any cause).	6, 12, 18 and 24 months
Secondary	Objective Response Rate (ORR)	ORR defined as the proportion of patients achieving a complete or partial response	3, 6, 9 and 12 months