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

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Collaborators:

Information provided by (Responsible Party):

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Tracking Information

First Submitted Date ^ICMJE

October 3, 2018

First Posted Date ^ICMJE

October 4, 2018

Last Update Posted Date

October 4, 2018

Actual Study Start Date ^ICMJE

November 1, 2018

Estimated Primary Completion Date

May 31, 2019 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Positioning of cabozantinib in the treatment pathway[ Time Frame: 24 months ]

Positioning of cabozantinib in the treatment pathway (second line, third line, fourth line or above)

Distribution of cabozantinib starting dose.[ Time Frame: Baseline ]

Distribution, mean (SD) and median (quartiles) cabozantinib starting dose.

Daily dose during treatment[ Time Frame: 24 months ]

Mean (SD) and median (quartiles) cabozantinib daily dose during treatment.

Proportion of patients with dose modifications[ Time Frame: 24 months ]

Proportion of patients with dose modifications and mean (SD) and median (quartiles) number of dose modifications per patient.

Median time to first dose modification[ Time Frame: 24 months ]

Distribution of reasons for dose modifications.[ Time Frame: 24 months ]

Proportion of patients permanently discontinuing cabozantinib.[ Time Frame: 24 months ]

Distribution of reasons for discontinuation of treatment[ Time Frame: 24 months ]

Median duration of cabozantinib treatment (months)[ Time Frame: 24 months ]

Distribution of relevant concomitant treatments[ Time Frame: 24 months ]

Radiation procedures, denosumab, bisphosphonates.

Distribution of systemic therapies prescribed for advanced RCC after discontinuation of cabozantinib.[ Time Frame: 24 months ]

Original Primary Outcome Measures ^ICMJE

Same as current

Current Secondary Outcome Measures ^ICMJE

Distribution of RCC stage and histological type at initial RCC diagnosis[ Time Frame: baseline ]
Time (months) from advanced RCC diagnosis to cabozantinib initiation.[ Time Frame: baseline ]
Mean (SD) and median (quartiles) time (months
Distribution of RCC stage at cabozantinib initiation.[ Time Frame: baseline ]
Distribution of metastatic sites.[ Time Frame: baseline ]
Metastatic sites (lung / liver / bone / lymph node / brain / visceral other) documented co-morbidities and distribution of relevant co-morbidities.
Distribution of International Metastatic Renal Cell Carcinoma Database Consortium (IMDC) risk group[ Time Frame: baseline ]
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).
Progression Free Survival (PFS)[ Time Frame: 3, 6, 9, 12, 18 and 24 months and median 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
Overall Survival (OS)[ Time Frame: 6, 12, 18 and 24 months ]
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).
Objective Response Rate (ORR)[ Time Frame: 3, 6, 9 and 12 months ]
ORR defined as the proportion of patients achieving a complete or partial response

Descriptive Information

Brief Title ^ICMJE

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 ^ICMJE

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

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.

Detailed Description

Study Type ^ICMJE

Observational

Study Phase

Study Design ^ICMJE

Allocation:
Intervention Model:
Intervention Model Description:
Masking: Observational
Masking Description:
Primary Purpose:

Condition ^ICMJE

Intervention ^ICMJE

Study Arms

Recruitment Information

Recruitment Status ^ICMJE

Not yet recruiting

Estimated Enrollment ^ICMJE

100

Original Estimated Enrollment ^ICMJE

Same as current

Estimated Study Completion Date

May 31, 2019

Estimated Primary Completion Date

May 31, 2019 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Sex/Gender

Sexes Eligible for Study:

All

Ages

18 Years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Listed Location Countries ^ICMJE

United Kingdom

Removed Location Countries

Administrative Information

Has Data Monitoring Committee

U.S. FDA-regulated Product

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

Plan to Share IPD:

Responsible Party

，

Study Sponsor ^ICMJE

Ipsen

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director: Ipsen Medical Director Ipsen

PRS Account

Verification Date

October 2018

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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