JPRN-jRCT2031210099
Completed
Phase 4
A Global, Multicenter, Open-label, Expanded Access Program for Enfortumab Vedotin in Patients with Locally Advanced or Metastatic Urothelial Carcinoma (EV-902)
Steinberg Joyce0 sites350 target enrollmentMay 18, 2021
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Steinberg Joyce
- Enrollment
- 350
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Patient has locally advanced or metastatic urothelial carcinoma
- •2\. Patient has previously received a programmed death receptor\-1 (PD\-1\) or programmed death\-ligand 1 (PD\-L1\) inhibitor, and a platinum\-containing chemotherapy in the neoadjuvant/adjuvant, locally advanced or metastatic setting.
- •3\. Patient has no other treatment options available under standard of care.
- •4\. Patient has the following baseline laboratory data:
- •a.absolute neutrophil count \>\= 1500/mm^3 (\>\= 1\.5 x 10^9/L)
- •b.platelet count \>\= 75,000/mm^3 (\>\= 75 x 10^9/L)
- •c.hemoglobin \>\= 8 g/dL
- •d.serum bilirubin \=\< 1\.5 x upper limit of normal (ULN) or \=\< 3 x ULN for patients with Gilbert's disease
- •e.Creatinine clearance (CrCl) \>\= 15 mL/min as estimated per institutional standards or as measured by 24\-hour urine collection (glomerular filtration rate can also be used instead of CrCl)
- •f.alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \=\< 2\.5 x ULN or \=\< 3 x ULN for patients with liver metastases
Exclusion Criteria
- •1\. Patient has previously received treatment in an enfortumab vedotin clinical trial or a clinical trial that included enfortumab vedotin as 1 of the treatment options (even if the patient was not given enfortumab vedotin).
- •2\. Patient is a candidate for any ongoing enfortumab vedotin clinical trial.
- •3\. Patient has ongoing sensory or motor neuropathy grade \>\= 2\.
- •4\. Patient has symptomatic central nervous system metastases.
- •5\. Patient has ongoing clinically significant toxicity (grade 2 or higher with the exception of alopecia) associated with prior treatment.
- •6\. Patient has known hypersensitivity to enfortumab vedotin or to any excipient contained in the drug formulation of enfortumab vedotin (including histidine, trehalose dehydrate, and polysorbate 20\); OR patient has known hypersensitivity to biopharmaceuticals produced in Chinese Hamster Ovary cells.
- •7\. Patient completed radiotherapy, major surgery or prior anti\-cancer therapy \=\< 2 weeks before first enfortumab vedotin dose.
- •8\. Patient has history of uncontrolled diabetes mellitus \=\< 3 months of the first enfortumab vedotin dose. Uncontrolled diabetes is defined as hemoglobin A1c (HbA1c) \>\= 8% or HbA1c between 7% and \< 8% with associated diabetes symptoms (polyuria or polydipsia) that are not otherwise explained.
- •9\. Patient has an active viral, bacterial or fungal infection (including hepatitis B, hepatitis C, or human immunodeficiency virus) at the time of first dose of enfortumab vedotin. Routine antimicrobial prophylaxis is permitted.
- •10\. Patient has recent history of a cerebral vascular event (stroke or transient ischemic attack), unstable angina, myocardial infarction or cardiac symptoms (including congestive heart failure) consistent with New York Heart Association Classes III to IV that is not adequately treated and/or controlled at the time of first enfortumab vedotin dose.
Outcomes
Primary Outcomes
Not specified
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