Advanced Renal Cell CarcinomaNCT03696407
A Non-interventional Retrospective Study to Describe Early Clinical Experience With Cabozantinib in Patients With Advanced Renal Cell Carcinoma (RCC) in the UK
An observational study of Advanced Renal Cell Carcinoma, run by Ipsen at 6 sites in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Renal Cell Carcinoma
- How many people
- 108 participants
- Where
- 6 sitesUnited Kingdom
- Study dates
- 20 Dec 2018to 1 Aug 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Secondary/tertiary care service
Who may be able to join
- 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.
Who cannot join
- Decline or lack the capacity to consent for researcher access to their medical records (if living)
- Hospital medical records are unavailable for review
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United Kingdom6 sites
Royal Sussex County Hospital
Brighton, BN2 5BE
Addenbrooke's Hospital
Cambridge, CB2 0QQ
Beatson West of Scotland Cancer Centre
Glasgow, G12 0YN
Royal Surrey County Hospital
Guildford, GU27XX
St Bartholomew's Hospital
London, EC1A 7BE
The Christie Hospital
Manchester, M20 4BX
About this study
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)
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.
- Conditions
- Advanced Renal Cell Carcinoma
What is being measured
The primary outcome is the main question the study is designed to answer.
Positioning of cabozantinib in the treatment pathway
Positioning of cabozantinib in the treatment pathway (second line, third line, fourth line or above)
Measured: 24 months
Distribution of cabozantinib starting dose.
Distribution, mean (SD) and median (quartiles) cabozantinib starting dose.
Measured: Baseline
Daily dose during treatment
Mean (SD) and median (quartiles) cabozantinib daily dose during treatment.
Measured: 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.
Measured: 24 months
Median time to first dose modification
Measured: 24 months
Distribution of reasons for dose modifications.
Measured: 24 months
Proportion of patients permanently discontinuing cabozantinib.
Measured: 24 months
Distribution of reasons for discontinuation of treatment
Measured: 24 months
Median duration of cabozantinib treatment (months)
Measured: 24 months
Distribution of relevant concomitant treatments
Radiation procedures, denosumab, bisphosphonates.
Measured: 24 months
Distribution of systemic therapies prescribed for advanced RCC after discontinuation of cabozantinib.
Measured: 24 months
Secondary outcomes (8)
Distribution of RCC stage and histological type at initial RCC diagnosis
Measured: baseline
Time (months) from advanced RCC diagnosis to cabozantinib initiation.
Mean (SD) and median (quartiles) time (months
Measured: baseline
Distribution of RCC stage at cabozantinib initiation.
Measured: baseline
Distribution of metastatic sites.
Metastatic sites (lung / liver / bone / lymph node / brain / visceral other) documented co-morbidities and distribution of relevant co-morbidities.
Measured: baseline
Distribution of International Metastatic Renal Cell Carcinoma Database Consortium (IMDC) risk group
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).
Measured: baseline
Progression Free Survival (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
Measured: 3, 6, 9, 12, 18 and 24 months and median PFS.
Overall Survival (OS)
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).
Measured: 6, 12, 18 and 24 months
Objective Response Rate (ORR)
ORR defined as the proportion of patients achieving a complete or partial response
Measured: 3, 6, 9 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2018
- Study start20 Dec 2018
- Primary completion1 Aug 2019
- Study completion1 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Renal Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by IpsenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ipsen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ipsen Medical Director, Study director, Ipsen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03696407
- Sponsor's protocol ID
- A-GB-60000-017
- Status last verified
- Nov 2020
- First submitted
- 3 Oct 2018
- Last updated
- 5 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT03696407
- Acronym / sponsor ID
- A-GB-60000-017
- Conditions
- Advanced Renal Cell Carcinoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- IpsenIndustry (pharma, biotech, devices)
- Study start
- 20 Dec 2018 (actual)
- Primary completion
- 1 Aug 2019 (actual)
- Study completion
- 1 Aug 2019 (actual)
- First posted
- 4 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Secondary/tertiary care service
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- Decline or lack the capacity to consent for researcher access to their medical records (if living)
- Hospital medical records are unavailable for review
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
8 secondary outcomes
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
Distribution of RCC stage at cabozantinib initiation.
Time frame: baseline
Distribution of metastatic sites.
Time frame: baseline
Distribution of International Metastatic Renal Cell Carcinoma Database Consortium (IMDC) risk group
Time frame: baseline
Progression Free Survival (PFS)
Time frame: 3, 6, 9, 12, 18 and 24 months and median PFS.
Overall Survival (OS)
Time frame: 6, 12, 18 and 24 months
Objective Response Rate (ORR)
Time frame: 3, 6, 9 and 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ipsen Medical Director study director
Ipsen
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Advanced Renal Cell Carcinoma, run by Ipsen at 6 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Positioning of cabozantinib in the treatment pathway (time frame: 24 months). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2020.