NCT03696407

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
108

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2018

Shorter than P25 for all trials

Geographic Reach
1 country

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 3, 2018

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 4, 2018

Completed
3 months until next milestone

Study Start

First participant enrolled

December 20, 2018

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2019

Completed
Last Updated

November 5, 2020

Status Verified

November 1, 2020

Enrollment Period

7 months

First QC Date

October 3, 2018

Last Update Submit

November 4, 2020

Conditions

Advanced Renal Cell Carcinoma

Outcome Measures

Primary Outcomes (11)

  • Positioning of cabozantinib in the treatment pathway

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

    24 months

  • Distribution of cabozantinib starting dose.

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

    Baseline

  • Daily dose during treatment

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

    24 months

  • Proportion of patients with dose modifications

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

    24 months

  • Median time to first dose modification

    24 months

  • Distribution of reasons for dose modifications.

    24 months

  • Proportion of patients permanently discontinuing cabozantinib.

    24 months

  • Distribution of reasons for discontinuation of treatment

    24 months

  • Median duration of cabozantinib treatment (months)

    24 months

  • Distribution of relevant concomitant treatments

    Radiation procedures, denosumab, bisphosphonates.

    24 months

  • Distribution of systemic therapies prescribed for advanced RCC after discontinuation of cabozantinib.

    24 months

Secondary Outcomes (8)

  • Distribution of RCC stage and histological type at initial RCC diagnosis

    baseline

  • Time (months) from advanced RCC diagnosis to cabozantinib initiation.

    baseline

  • Distribution of RCC stage at cabozantinib initiation.

    baseline

  • Distribution of metastatic sites.

    baseline

  • Distribution of International Metastatic Renal Cell Carcinoma Database Consortium (IMDC) risk group

    baseline

  • +3 more secondary outcomes

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Secondary/tertiary care service

You may qualify if:

  • 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.

You may not qualify if:

  • Decline or lack the capacity to consent for researcher access to their medical records (if living)
  • Hospital medical records are unavailable for review

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Royal Sussex County Hospital

Brighton, BN2 5BE, United Kingdom

Location

Addenbrooke's Hospital

Cambridge, CB2 0QQ, United Kingdom

Location

Beatson West of Scotland Cancer Centre

Glasgow, G12 0YN, United Kingdom

Location

Royal Surrey County Hospital

Guildford, GU27XX, United Kingdom

Location

St Bartholomew's Hospital

London, EC1A 7BE, United Kingdom

Location

The Christie Hospital

Manchester, M20 4BX, United Kingdom

Location

Study Officials

  • Ipsen Medical Director

    Ipsen

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 3, 2018

First Posted

October 4, 2018

Study Start

December 20, 2018

Primary Completion

August 1, 2019

Study Completion

August 1, 2019

Last Updated

November 5, 2020

Record last verified: 2020-11

Locations

GB(6)