Clinical trial NCT03696407: A Non-interventional Retrospective Study to Describe Early Clinical Experience With Cabozantinib in Patients With Advanced Renal Cell Carcinoma (RCC) in the UK
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)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Advanced Renal Cell Carcinoma
Lead sponsor: Ipsen
Sponsor class: INDUSTRY
First posted: 2018-10-04
Enrollment: 108
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Secondary/tertiary care service

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Positioning of cabozantinib in the treatment pathway
timeFrame: 24 months
measure: Distribution of cabozantinib starting dose.
timeFrame: Baseline
measure: Daily dose during treatment
timeFrame: 24 months
measure: Proportion of patients with dose modifications
timeFrame: 24 months
measure: Median time to first dose modification
timeFrame: 24 months
measure: Distribution of reasons for dose modifications.
timeFrame: 24 months
measure: Proportion of patients permanently discontinuing cabozantinib.
timeFrame: 24 months
measure: Distribution of reasons for discontinuation of treatment
timeFrame: 24 months
measure: Median duration of cabozantinib treatment (months)
timeFrame: 24 months
measure: Distribution of relevant concomitant treatments
timeFrame: 24 months
measure: Distribution of systemic therapies prescribed for advanced RCC after discontinuation of cabozantinib.
timeFrame: 24 months
Secondary outcomes:
measure: Distribution of RCC stage and histological type at initial RCC diagnosis
timeFrame: baseline
measure: Time (months) from advanced RCC diagnosis to cabozantinib initiation.
timeFrame: baseline
measure: Distribution of RCC stage at cabozantinib initiation.
timeFrame: baseline
measure: Distribution of metastatic sites.
timeFrame: baseline
measure: Distribution of International Metastatic Renal Cell Carcinoma Database Consortium (IMDC) risk group
timeFrame: baseline
measure: Progression Free Survival (PFS)
timeFrame: 3, 6, 9, 12, 18 and 24 months and median PFS.
measure: Overall Survival (OS)
timeFrame: 6, 12, 18 and 24 months
measure: Objective Response Rate (ORR)
timeFrame: 3, 6, 9 and 12 months
Other outcomes:
Locations:
city: Brighton
country: United Kingdom
facility: Royal Sussex County Hospital
city: Cambridge
country: United Kingdom
facility: Addenbrooke's Hospital
city: Glasgow
country: United Kingdom
facility: Beatson West of Scotland Cancer Centre
city: Guildford
country: United Kingdom
facility: Royal Surrey County Hospital
city: London
country: United Kingdom
facility: St Bartholomew's Hospital
city: Manchester
country: United Kingdom
facility: The Christie Hospital
Study officials:
affiliation: Ipsen
name: Ipsen Medical Director
role: STUDY_DIRECTOR
References: