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

March 9, 2023 updated by: Hoffmann-La Roche

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

13

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Buenos Aires, Argentina, B1610BAL
        • Productos Roche S.A. Quimica e Industrial, División Farmacéutica

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with histologically or cytologically documented locally advanced or metastatic urothelial carcinoma (including renal pelvis, ureters, urinary bladder, and urethra) that have received the indication for treatment with atezolizumab as per local label (disease progression during or following platinum containing therapy) in the context of routine clinical practice.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percentage of Participants with Adverse Events (AE)
Time Frame: Up to approximately 2 years.
Up to approximately 2 years.

Secondary Outcome Measures

Outcome Measure
Time Frame
Percentage of participants with Confirmed Objective Response (ORR) of Complete Response (CR) or Partial Response (PR)
Time Frame: Up to approximately 2 years.
Up to approximately 2 years.
Duration of Response (DOR)
Time Frame: Up to approximately 2 years.
Up to approximately 2 years.
Progression Free Survival (PFS)
Time Frame: Up to approximately 2 years.
Up to approximately 2 years.
Overall Survival (OS)
Time Frame: Up to approximately 2 years.
Up to approximately 2 years.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hoffmann-La Roche

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 9, 2018

Primary Completion (Actual)

March 2, 2019

Study Completion (Actual)

March 2, 2019

Study Registration Dates

First Submitted

November 1, 2017

First Submitted That Met QC Criteria

November 1, 2017

First Posted (Actual)

November 6, 2017

Study Record Updates

Last Update Posted (Actual)

March 13, 2023

Last Update Submitted That Met QC Criteria

March 9, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ML39853

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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