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Completed

NCT Number: NCT03696407

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Royal Sussex County Hospital, Brighton, United Kingdom

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Ipsen

Industry

Registry information

Official study 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)

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Oct 4, 2018
Registry last updated
Nov 5, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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