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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

Tracking Information
First Submitted Date November 1, 2017
First Posted Date November 6, 2017
Last Update Posted Date February 12, 2018
Estimated Study Start Date February 28, 2018
Estimated Primary Completion Date December 31, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: November 1, 2017)
Percentage of Participants with Adverse Events (AE) [ Time Frame: Up to approximately 2 years. ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: November 1, 2017)
  • Percentage of participants with Confirmed Objective Response (ORR) of Complete Response (CR) or Partial Response (PR) [ Time Frame: Up to approximately 2 years. ]
  • Duration of Response (DOR) [ Time Frame: Up to approximately 2 years. ]
  • Progression Free Survival (PFS) [ Time Frame: Up to approximately 2 years. ]
  • Overall Survival (OS) [ Time Frame: Up to approximately 2 years. ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title A Study of the Safety of Atezolizumab in Patients With Advanced or Metastatic Urothelial Carcinoma in Argentina
Official Title An Observational Study of the Safety of Atezolizumab in Patients With Advanced or Metastatic Urothelial Carcinoma in Argentina
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 Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition Urothelial Carcinoma
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).
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: November 1, 2017)
30
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 31, 2019
Estimated Primary Completion Date December 31, 2019   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT03330886
Other Study ID Numbers ML39853
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party Hoffmann-La Roche
Study Sponsor Hoffmann-La Roche
Collaborators Not Provided
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
PRS Account Hoffmann-La Roche
Verification Date February 2018