Study on the Utilization of Cabozantinib in Adult Patients With Advanced or Metastatic Renal Cell Carcinoma (RCC) in 2nd Line Treatment Following Prior Vascular Endothelial Growth Factor (VEGF)-Targeted Therapy Under Real-real Life Clinical Setting in France.

NCT04609800 | Withdrawn

• 1 other identifier: A-FR-60000-070
• Study Type: observational
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of the protocol is to assess the Overall Survival (OS) at 1 year in patients after cabozantinib initiation.

Conditions

Renal Cell Carcinoma

Keywords

Renal Cell Carcinoma (clear cell or non-clear cell)

Outcome Measures

Primary Outcomes (1)

• Overall survival (OS) rate at 1 year after cabozantinib initiation

  OS is the time between treatment initiation and the date of death from any cause. For participants who are alive, their survival time will be censored at the last date that they were known to be alive if before 1 year.

  up to 12 months

Secondary Outcomes (10)

• Objective Response Rate (ORR) at 1 year

  Day 15, 1 month, 3, 6 and 12 months

• Best Overall Response (BOR) at 1 year

  Day 15, 1 month, 3, 6 and 12 months

• Progression Free Survival (PFS) at 1 year

  Day 15, 1 month, 3, 6 and 12 months

• Previous systemic neoadjuvant and adjuvant therapies for RCC prior cabozantinib initiation in terms of nature of the therapy, duration, and reason for discontinuation.

  Baseline

• First-line therapy for RCC prior cabozantinib initiation in terms of nature of the therapy, duration, and reason for discontinuation.

  Baseline

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Data of 195 participants suffering from advanced or metastatic RCC and treated with cabozantinib will be collected. During the study, two questionnaires (FKSI 19 and BPI-SF) will be filled in by patients.

You may qualify if:

• Male or female ≥ 18 age at the time of cabozantinib initiation
• Pathologically confirmed diagnosis of Renal Cell Carcinoma (Clear Cell or non-Clear Cell) cancer considered as advanced or metastatic at the time of cabozantinib initiation
• Intention to be treated with cabozantinib tablets according to the current local Summary of Product Characteristics (SmPC) (France)
• Initiating cabozantinib as a second line of treatment (Baseline visit must be performed before cabozantinib first intake)

You may not qualify if:

• He/she is already included in an interventional trial with an investigational product at the same time.

Sponsors & Collaborators

• Ipsen: lead

MeSH Terms

Conditions

Carcinoma, Renal Cell

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases

Study Officials

• Ipsen Medical Director

  Ipsen

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 7, 2020
• First Posted: October 30, 2020
• Study Start: November 6, 2020
• Primary Completion: May 10, 2023
• Study Completion: May 10, 2023
• Last Updated: December 21, 2020

Record last verified: 2020-12