NCT02589717
Approved
N/A
An Open-Label, Multicenter, Expanded Access Program for Atezolizumab in Patients With Locally Advanced or Metastatic Urothelial Carcinoma After Failure With Platinum-Containing Chemotherapy.
ConditionsUrothelial Carcinoma
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Urothelial Carcinoma
- Sponsor
- Genentech, Inc.
- Status
- Approved
- Last Updated
- 9 years ago
Overview
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.
Investigators
Eligibility 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
Outcomes
Primary Outcomes
Not specified
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