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

NCT ID: NCT04637204

Last Updated: 2021-02-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1540 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-11-24

Study Completion Date

2020-12-11

Brief Summary

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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).

Detailed Description

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Conditions

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Renal Cell Carcinoma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Subgroup 1

Patients with index treatment: cabozantinib treatment post vascular endothelial growth factor (VEGF)-targeted therapy in any line, except axitinib.

Cabozantinib

Intervention Type DRUG

oral therapy

Subgroup 2

Patients with index treatment: axitinib treatment post VEGF-targeted therapy in any line, except cabozantinib.

Axitinib

Intervention Type DRUG

oral therapy

Subgroup 3

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

Cabozantinib

Intervention Type DRUG

oral therapy

Subgroup 4

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

Axitinib

Intervention Type DRUG

oral therapy

Interventions

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Cabozantinib

oral therapy

Intervention Type DRUG

Axitinib

oral therapy

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ipsen

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ipsen Medical Director

Role: STUDY_DIRECTOR

Ipsen

Locations

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Ipsen Facility

Slough, , United Kingdom

Site Status

Countries

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United Kingdom

References

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Brown J, Harrow B, Marciniak A, McCarthy C, Houchard A, Cirneanu L, Protheroe A. Cabozantinib and Axitinib After Vascular Endothelial Growth Factor Therapy in Patients with Advanced Renal Cell Carcinoma: A Retrospective Cohort Study from England. Drugs Real World Outcomes. 2024 Jun;11(2):195-207. doi: 10.1007/s40801-023-00415-w. Epub 2024 Jan 24.

Reference Type DERIVED
PMID: 38265633 (View on PubMed)

Other Identifiers

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CLIN-60000-450

Identifier Type: -

Identifier Source: org_study_id

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