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NCT03330886 Clinical Trial

A Study of the Safety of Atezolizumab in Patients With Advanced or Metastatic Urothelial Carcinoma in Argentina

Urothelial Carcinoma Clinical Trial

Official title:
An Observational Study of the Safety of Atezolizumab in Patients With Advanced or Metastatic Urothelial Carcinoma in Argentina

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03330886
Other study ID # ML39853
Secondary ID
Status Completed
Phase
First received
Last updated
Start date February 9, 2018
Est. completion date March 2, 2019

Study information
Verified date March 2023
Source Hoffmann-La Roche
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The main purpose is to study the safety and effectiveness of atezolizumab in patients with locally advanced or metastatic urothelial carcinoma whose disease has worsened during or following platinum-containing chemotherapy, or within 12 months of receiving platinum-containing chemotherapy, either before (neoadjuvant) or after (adjuvant) surgical treatment in common clinical practice settings in Argentina.

Recruitment information / eligibility
Status Completed
Enrollment 13
Est. completion date March 2, 2019
Est. primary completion date March 2, 2019
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - Signed an informed consent form submitted to the Administración Nacional de Medicamentos Alimentos y Tecnología Médica (ANMAT) - Histologically or cytologically documented locally advanced or metastatic urothelial carcinoma (including renal pelvis, ureters, urinary bladder, and urethra). - Have received at least one dose of atezolizumab as per local label and clinical practice. Exclusion Criteria: - Contraindicated atezolizumab therapy

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Atezolizumab
Atezolizumab will be administered via IV at a 1200-mg dose over 60 minutes every 3 weeks (to be reduced to 30 minutes every 3 weeks if the first dose is tolerated).

Locations
Country Name City State
Argentina Productos Roche S.A. Quimica e Industrial, División Farmacéutica Buenos Aires

Sponsors (1)
Lead Sponsor Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

Argentina, 

Outcome
Type Measure Description Time frame Safety issue
Primary Percentage of Participants with Adverse Events (AE) Up to approximately 2 years.
Secondary Percentage of participants with Confirmed Objective Response (ORR) of Complete Response (CR) or Partial Response (PR) Up to approximately 2 years.
Secondary Duration of Response (DOR) Up to approximately 2 years.
Secondary Progression Free Survival (PFS) Up to approximately 2 years.
Secondary Overall Survival (OS) Up to approximately 2 years.
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