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Real-world Treatment Patterns and Outcomes Among aRCC Patients on Cabozantinib or Axitinib in England

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ClinicalTrials.gov Identifier: NCT04637204
Recruitment Status : Completed
First Posted : November 19, 2020
Last Update Posted : February 1, 2021
Sponsor:
Information provided by (Responsible Party):
Ipsen

Brief Summary:
The present study will aim to describe and understand, in the real-world, the clinical characteristics, treatment patterns and outcomes of advanced renal cell carcinoma (aRCC) patients treated with cabozantinib or axitinib monotherapy in England using the existing data source, Cancer Analysis System (CAS).

Condition or disease Intervention/treatment
Renal Cell Carcinoma Drug: Cabozantinib Drug: Axitinib

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Study Type : Observational
Actual Enrollment : 1540 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Treatment Patterns and Outcomes Among Advanced Renal Cell Carcinoma (aRCC) Patients Treated With Cabozantinib or Axitinib Therapy: Non Interventional, Retrospective Study Using Data From Public Health England's Cancer Analysis System
Actual Study Start Date : November 24, 2020
Actual Primary Completion Date : December 11, 2020
Actual Study Completion Date : December 11, 2020


Group/Cohort Intervention/treatment
Subgroup 1
Patients with index treatment: cabozantinib treatment post vascular endothelial growth factor (VEGF)-targeted therapy in any line, except axitinib.
Drug: Cabozantinib
oral therapy

Subgroup 2
Patients with index treatment: axitinib treatment post VEGF-targeted therapy in any line, except cabozantinib.
Drug: Axitinib
oral therapy

Subgroup 3
Patients with index treatment: cabozantinib treatment post axitinib by line of therapy (2L, 3L, 3L+)
Drug: Cabozantinib
oral therapy

Subgroup 4
Patients with index treatment: axitinib treatment post cabozantinib by line of therapy (2L, 3L, 3L+)
Drug: Axitinib
oral therapy




Primary Outcome Measures :
  1. Duration of therapy for the index treatments of interest stratified by line of therapy (LoT) [ Time Frame: From start of index treatment up to the end of treatment or start of subsequent therapy during data collection period (01 January 2011 and 31 January 2020) ]
    Duration of therapy will be measured from the initiation of the index treatment until the projected end date of the index treatment (or start of the subsequent therapy). (subgroups 1 to 4)

  2. Time between subsequent treatment lines [ Time Frame: From baseline until the end of data collection period (01 January 2011 and 31 January 2020) ]
    Time gap between the projected end date of the index treatment (cabozantinib or axitinib) until the start of the subsequent treatment. (subgroups 1 to 4)

  3. Sequencing of treatments (any treatments received from aRCC diagnosis until the end of follow up or death) [ Time Frame: From baseline until the end of data collection period (01 January 2011 and 31 January 2020) ]
    Treatment sequencing will be presented using a Sankey diagram that visualises the regimens received within each line of therapy and the number and percentage of patients who received those particular regimens.


Secondary Outcome Measures :
  1. Time from aRCC diagnosis to initial SACT initiation [ Time Frame: From baseline until the end of data collection period (01 January 2011 and 31 January 2020) ]
    Defined as the time from diagnosis of aRCC until the start date of the first cycle of the SACT regimen (i.e., 1st LoT start). (subgroups 1 to 4)

  2. Time from RCC diagnosis to initial SACT initiation [ Time Frame: From baseline until the end of data collection period (01 January 2011 and 31 January 2020) ]
    Time from RCC diagnosis to initial SACT initiation will be defined as the time from diagnosis of RCC until the start date of the first cycle of the SACT regimen. (subgroups 1 to 4)

  3. Time from RCC diagnosis to treatment initiation of cabozantinib [ Time Frame: From baseline until the end of data collection period (01 January 2011 and 31 January 2020) ]
    Time from diagnosis of RCC until the start of the first prescription of cabozantinib. (subgroups 1 and 3)

  4. Time from RCC diagnosis to treatment initiation of axitinib [ Time Frame: From baseline until the end of data collection period (01 January 2011 and 31 January 2020) ]
    Time from diagnosis of RCC until the start of the prescription of axitinib.

  5. Time from aRCC diagnosis to treatment initiation of cabozantinib [ Time Frame: From baseline until the end of data collection period (01 January 2011 and 31 January 2020) ]
    Time from diagnosis of aRCC until the start of the first prescription of cabozantinib. (subgroups 1 and 3)

  6. Time from aRCC diagnosis to treatment initiation of axitinib [ Time Frame: From baseline until the end of data collection period (01 January 2011 and 31 January 2020) ]
    Time from diagnosis of aRCC until the start of the first prescription of axitinib. (subgroups 2 and 4)

  7. Overall survival (OS) [ Time Frame: From start of index treatment until death or end of data collection period (01 January 2011 and 31 January 2020 whichever occurs first ]
    Time from start of index treatment (cabozantinib/axitinib) until the date of death (from any cause) during the study period. (subgroups 1 to 4)

  8. Landmark survival [ Time Frame: 12 months ]
    Landmark survival will be defined as the time from start of the index treatment until date of death (from any cause) at specific time points (12, 18, and 24 months). (subgroups 1 to 4)

  9. Landmark survival [ Time Frame: 18 months ]
    Landmark survival will be defined as the time from start of the index treatment until date of death (from any cause) at specific time points (12, 18, and 24 months). (subgroups 1 to 4)

  10. Landmark survival [ Time Frame: 24 months ]
    Landmark survival will be defined as the time from start of the index treatment until date of death (from any cause) at specific time points (12, 18, and 24 months). (subgroups 1 to 4)

  11. Time to next treatment (or death) (TTNT) [ Time Frame: From start of index treatment until the start of subsequent therapy during data collection period (01 January 2011 and 31 January 2020) ]
    Time to next treatment (or death) (TTNT) will be defined as the time from start of index treatment until the start of the subsequent LoT (subgroups 1 to 4)

  12. Time to treatment discontinuation (TTTD) [ Time Frame: From start of index treatment until discontinuation or death during data collection period (01 January 2011 and 31 January 2020) ]
    Time to treatment discontinuation (TTTD) will be defined as time from treatment initiation until treatment discontinuation or death. (subgroups 1 to 4)



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

The study population will include all adult patients diagnosed with aRCC during the study period and identified in the study data source (CAS).

The study population will comprise two types of aRCC patients:

  • Patients who had advanced disease (Stage III/IV) at diagnosis, and
  • Patients who had non-advanced disease (Stage I/II or missing information on Staging) at diagnosis but advanced at a later date during the study period (proxied by receipt of a SACT treatment indicative of advanced RCC)
Criteria

Inclusion Criteria:

  • Patients with initial renal cancer diagnosis
  • Patients diagnosed at Stage III or Stage IV (as defined in CAS): as evidence for advanced/metastatic RCC
  • For patients with Stage I/II or patients with missing information on Staging
  • Patients who received SACT1 treatment following initial renal cancer diagnosis through end of enrolment (31 July 2019)
  • Patients who received cabozantinib or axitinib treatment

Exclusion Criteria:

  • Diagnosis of concomitant tumour apart from non-melanoma skin cancer in the three years prior to the diagnosis of aRCC
  • Less than 18 years of age at the time of initial aRCC diagnosis
  • SACT treatment more than 30 days prior to initial aRCC diagnosis

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): NCT04637204


Locations
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United Kingdom
Ipsen Facility
Slough, United Kingdom, Sl1 3XE
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: NCT04637204    
Other Study ID Numbers: CLIN-60000-450
First Posted: November 19, 2020    Key Record Dates
Last Update Posted: February 1, 2021
Last Verified: January 2021

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Studies a U.S. FDA-regulated Drug 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
Axitinib
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action