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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03330886
Recruitment Status : Unknown
Verified February 2018 by Hoffmann-La Roche.
Recruitment status was:  Not yet recruiting
First Posted : November 6, 2017
Last Update Posted : February 12, 2018
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Study Description
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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.

Condition or disease Intervention/treatment
Urothelial Carcinoma Drug: Atezolizumab

Study Design
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Study Type : Observational
Estimated Enrollment : 30 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: An Observational Study of the Safety of Atezolizumab in Patients With Advanced or Metastatic Urothelial Carcinoma in Argentina
Estimated Study Start Date : February 28, 2018
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Intervention Details:
  • 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).

Outcome Measures
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Primary Outcome Measures :
  1. Percentage of Participants with Adverse Events (AE) [ Time Frame: Up to approximately 2 years. ]

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

Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03330886


Contacts
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Contact: Reference Study ID: ML39853 www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. only) global-roche-genentech-trials@gene.com

Sponsors and Collaborators
Hoffmann-La Roche
Investigators
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Study Director: Clinical Trials Hoffmann-La Roche
More Information
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Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT03330886    
Other Study ID Numbers: ML39853
First Posted: November 6, 2017    Key Record Dates
Last Update Posted: February 12, 2018
Last Verified: February 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Transitional Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
 Neoplasms
Atezolizumab
Antineoplastic Agents