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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

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ClinicalTrials.gov Identifier: NCT03696407
Recruitment Status : Completed
First Posted : October 4, 2018
Last Update Posted : August 26, 2019
Sponsor:
Information provided by (Responsible Party):
Ipsen

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.

Condition or disease
Advanced Renal Cell Carcinoma

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Study Type : Observational
Actual Enrollment : 108 participants
Observational Model: Cohort
Time Perspective: Retrospective
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

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. 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)

  2. Distribution of cabozantinib starting dose. [ Time Frame: Baseline ]
    Distribution, mean (SD) and median (quartiles) cabozantinib starting dose.

  3. Daily dose during treatment [ Time Frame: 24 months ]
    Mean (SD) and median (quartiles) cabozantinib daily dose during treatment.

  4. 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.

  5. Median time to first dose modification [ Time Frame: 24 months ]
  6. Distribution of reasons for dose modifications. [ Time Frame: 24 months ]
  7. Proportion of patients permanently discontinuing cabozantinib. [ Time Frame: 24 months ]
  8. Distribution of reasons for discontinuation of treatment [ Time Frame: 24 months ]
  9. Median duration of cabozantinib treatment (months) [ Time Frame: 24 months ]
  10. Distribution of relevant concomitant treatments [ Time Frame: 24 months ]
    Radiation procedures, denosumab, bisphosphonates.

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

Secondary Outcome Measures :
  1. Distribution of RCC stage and histological type at initial RCC diagnosis [ Time Frame: baseline ]
  2. Time (months) from advanced RCC diagnosis to cabozantinib initiation. [ Time Frame: baseline ]
    Mean (SD) and median (quartiles) time (months

  3. Distribution of RCC stage at cabozantinib initiation. [ Time Frame: baseline ]
  4. 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.

  5. 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).

  6. 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

  7. 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).

  8. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Secondary/tertiary care service
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

Information from the National Library of Medicine

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


Locations
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United Kingdom
Royal Sussex County Hospital
Brighton, United Kingdom, BN2 5BE
Addenbrooke's Hospital
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
Sponsors and Collaborators
Ipsen
Investigators
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Study Director: Ipsen Medical Director Ipsen

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Responsible Party: Ipsen
ClinicalTrials.gov Identifier: NCT03696407     History of Changes
Other Study ID Numbers: A-GB-60000-017
2018-002127-42 ( EudraCT Number )
First Posted: October 4, 2018    Key Record Dates
Last Update Posted: August 26, 2019
Last Verified: August 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Renal Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases