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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|ClinicalTrials.gov Identifier: NCT03696407|
Recruitment Status : Completed
First Posted : October 4, 2018
Last Update Posted : August 26, 2019
|Condition or disease|
|Advanced Renal Cell Carcinoma|
|Study Type :||Observational|
|Actual Enrollment :||108 participants|
|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)|
|Actual Study Start Date :||December 20, 2018|
|Actual Primary Completion Date :||August 1, 2019|
|Actual Study Completion Date :||August 1, 2019|
- 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 ]
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03696407
|Royal Sussex County Hospital|
|Brighton, United Kingdom, BN2 5BE|
|Cambridge, United Kingdom, CB2 0QQ|
|Beatson West of Scotland Cancer Centre|
|Glasgow, United Kingdom, G12 0YN|
|Royal Surrey County Hospital|
|Guildford, United Kingdom, GU27XX|
|St Bartholomew's Hospital|
|London, United Kingdom, EC1A 7BE|
|The Christie Hospital|
|Manchester, United Kingdom, M20 4BX|
|Study Director:||Ipsen Medical Director||Ipsen|