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An Expanded Access Study of Atezolizumab in Participants With Locally Advanced or Metastatic Urothelial Carcinoma After Failure With Platinum-Containing Chemotherapy

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: NCT02589717
Expanded Access Status : Approved for marketing
First Posted : October 28, 2015
Last Update Posted : November 2, 2016
Sponsor:
Information provided by (Responsible Party):
Genentech, Inc.

Brief Summary:
This is an open-label, multicenter, single-arm, expanded access program (EAP) designed to provide atezolizumab access to participants with locally advanced or metastatic urothelial carcinoma that has progressed on, or is intolerant to, a platinum-containing chemotherapy regimen.

Condition or disease Intervention/treatment
Urothelial Carcinoma Drug: Atezolizumab [TECENTRIQ]

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Study Type : Expanded Access
  See clinical trials of the intervention/treatment in this expanded access record.
Official Title: An Open-Label, Multicenter, Expanded Access Program for Atezolizumab in Patients With Locally Advanced or Metastatic Urothelial Carcinoma After Failure With Platinum-Containing Chemotherapy.
Study Start Date : November 2015
Actual Primary Completion Date : August 2016
Actual Study Completion Date : August 2016



Intervention Details:
  • Drug: Atezolizumab [TECENTRIQ]
    Atezolizumab 1200 mg will be administered by IV infusion q3w. Initial IV infusion will be given over 60 minutes and subsequent infusions will be given over 30 minutes.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Able to comply with the study protocol, in the investigator's judgment
  • Histologically or cytologically documented locally advanced or metastatic urothelial carcinoma (including renal pelvis, ureters, urinary bladder, and urethra)
  • Disease progression during or following treatment with at least one platinum-containing regimen (e.g., gemcitabine and cisplatin [GC], methotrexate, vinblastine, doxorubicin, and cisplatin [MVAC], carboplatin and gemcitabine [CarboGem], etc.) for inoperable locally advanced or metastatic urothelial carcinoma or disease recurrence
  • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1, or 2
  • Life expectancy >/= 12 weeks
  • Adequate hematologic and end-organ function, defined by laboratory results obtained within 14 days prior to the first study treatment
  • For women who are not postmenopausal (>/= 12 months of non-therapy-induced amenorrhea) or surgically sterile (absence of ovaries and/or uterus): agreement to remain abstinent or use single or combined non-hormonal contraceptive methods that result in a failure rate of <1% per year during the treatment period and for at least 90 days after the last dose of study drug

Exclusion Criteria:

  • Treatment with any other investigational agent or participation in another clinical trial with therapeutic intent within 28 days prior to enrollment
  • Treatment with chemotherapy 14 days prior to enrollment; however, participants may be re-screened after the 14-day washout period
  • Treatment with radiotherapy 7 days prior to enrollment; however, participants may be re-screened after the 14-day washout period
  • Known primary central nervous system (CNS) malignancy or symptomatic CNS metastases
  • Pregnant or lactating, or intending to become pregnant during the study
  • Significant cardiovascular disease, such as New York Heart Association cardiac disease (Class II or greater), myocardial infarction within 3 months prior to randomization, unstable arrhythmias, or unstable angina
  • Severe infections within 4 weeks prior to enrollment, including, but not limited to, hospitalization for complications of infection, bacteremia, or severe pneumonia
  • Received therapeutic oral or intravenous (IV) antibiotics within 14 days prior to enrollment; however, participants may be re-screened after the 14-day washout period
  • Major surgical procedure within 4 weeks prior to enrollment or anticipation of need for a major surgical procedure during the course of the study other than for diagnosis
  • History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins
  • Known hypersensitivity or allergy to biopharmaceuticals produced in Chinese hamster ovary cells or any component of the atezolizumab formulation
  • Any other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of disease or a condition that contraindicates the use of the investigational drug or renders the participant at high risk for treatment complications
  • Participants with active hepatitis B
  • Active tuberculosis
  • Administration of a live, attenuated vaccine within 4 weeks prior to enrollment or anticipation that such a live, attenuated vaccine will be required during the study
  • Treatment with systemic immunostimulatory agents (including, but not limited to, interferons or IL-2) within 4 weeks or five half-lives of the drug, whichever is shorter, prior to enrollment
  • Treatment with systemic corticosteroids or other systemic immunosuppressive medications (including, but not limited to, prednisone, dexamethasone, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor [anti-TNF] agents) within 2 weeks prior to enrollment or anticipated requirement for systemic immunosuppressive medications during the trial

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): NCT02589717


Locations
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United States, Arizona
Scottsdale, Arizona, United States, 85258
Tucson, Arizona, United States, 85710
United States, California
Duarte, California, United States, 91010
Oakland, California, United States, 94611
Stanford, California, United States, 94305
United States, Colorado
Denver, Colorado, United States, 80218
United States, Connecticut
New Haven, Connecticut, United States, 06520
West Hartford, Connecticut, United States, 06119
United States, Florida
Miami Beach, Florida, United States, 33140
Tampa, Florida, United States, 33612
United States, Illinois
Harvey, Illinois, United States, 60426
Springfield, Illinois, United States, 62794-9677
United States, Indiana
Goshen, Indiana, United States, 46526
Indianapolis, Indiana, United States, 46237
United States, Iowa
Sioux City, Iowa, United States, 51101
United States, Kentucky
Louisville, Kentucky, United States, 40202
United States, Louisiana
New Orleans, Louisiana, United States, 70112
United States, Massachusetts
Boston, Massachusetts, United States, 02114
Boston, Massachusetts, United States, 02115
Boston, Massachusetts, United States, 02215
United States, Michigan
Ann Arbor, Michigan, United States, 48106
Detroit, Michigan, United States, 48202
United States, Minnesota
St. Cloud, Minnesota, United States, 56303
United States, Mississippi
Jackson, Mississippi, United States, 39202
United States, Missouri
Saint Louis, Missouri, United States, 63110
United States, New Mexico
Albuquerque, New Mexico, United States, 87131-0001
United States, New York
Abany, New York, United States, 12208
New York, New York, United States, 10016
Rochester, New York, United States, 14642
United States, Ohio
Columbus, Ohio, United States, 43210
United States, Oregon
Eugene, Oregon, United States, 97401-8122
United States, Pennsylvania
Easton, Pennsylvania, United States, 18045
Philadelphia, Pennsylvania, United States, 19107
Pittsburgh, Pennsylvania, United States, 15212
United States, South Carolina
Charleston, South Carolina, United States, 29425
United States, Texas
Houston, Texas, United States, 77030
San Antonio, Texas, United States, 78229
United States, Virginia
Charlottesville, Virginia, United States, 22908
Norfolk, Virginia, United States, 23502
United States, Washington
Spokane, Washington, United States, 99208
Sponsors and Collaborators
Genentech, Inc.
Investigators
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Study Director: Clinical Trials Genentech, Inc.
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Responsible Party: Genentech, Inc.
ClinicalTrials.gov Identifier: NCT02589717    
Other Study ID Numbers: ML29725
First Posted: October 28, 2015    Key Record Dates
Last Update Posted: November 2, 2016
Last Verified: November 2016
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Transitional Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Atezolizumab
Antineoplastic Agents