A Study of the Safety of Atezolizumab in Patients With Advanced or Metastatic Urothelial Carcinoma in Argentina
Completed
- Conditions
- Urothelial Carcinoma
- Registration Number
- NCT03330886
- Lead Sponsor
- Hoffmann-La Roche
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 13
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
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Percentage of Participants with Adverse Events (AE) Up to approximately 2 years.
- Secondary Outcome Measures
Name Time Method Duration of Response (DOR) Up to approximately 2 years. Progression Free Survival (PFS) Up to approximately 2 years. Overall Survival (OS) Up to approximately 2 years. Percentage of participants with Confirmed Objective Response (ORR) of Complete Response (CR) or Partial Response (PR) Up to approximately 2 years.
Trial Locations
- Locations (1)
Productos Roche S.A. Quimica e Industrial, División Farmacéutica
🇦🇷Buenos Aires, Argentina