Last updated on February 2016

Open-Label, Multicenter, Ph 3 Study to Evaluate the Efficacy and Tolerability of Intravesical Vicinium™ in Subjects With Non Muscle-Invasive Carcinoma in Situ and/or High-Grade Papillary Disease of the Bladder Treated With BCG. Clinical trial NCT02449239, VB4-845-02-IIIA.

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Bladder Cancer
  • Age: 18 Years
  • Gender: Male or Female

Inclusion Criteria:

  • Histologically-confirmed non muscle-invasive bladder cancer - CIS, high grade Ta or any grade T1 papillary disease or CIS plus papillary disease following adequate BCG treatment
  • The CIS, Ta or T1 disease is documented as unresponsive to (i.e., not intolerant) adequate BCG therapy
  • Females of childbearing potential and all males with partners of childbearing age are eligible only if they agree to use highly effective contraceptive techniques or abstinence during the 24-month study period
  • Bladder biopsy mapping the location of the tumors and quantifying the affected area of bladder within 8 weeks before study drug administration
  • Life expectancy of at least 4 years
  • Adequate organ function, as defined by the following criteria:
    • Serum aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤3.0 x upper limit of normal (ULN)
    • Total serum bilirubin ≤1.5 x ULN (CTCAE Grade ≤1)
    • Serum creatinine ≤2.0 x ULN; subjects with serum creatinine >1 x ULN must also have creatinine clearance ≥50 mL/min
    • Hemoglobin ≥8.0 g/dL; subjects receiving therapeutic erythropoietin preparations (i.e., epoetin alfa, darbepoetin alfa) are eligible to enroll
    • Absolute neutrophil count ≥1500 x 109/L
    • Platelets ≥75,000 x 109/L

Exclusion Criteria:

  • The subject is pregnant or breastfeeding
  • Evidence of urethral or upper tract transitional cell carcinoma (TCC) by biopsy or upper tract radiological imaging or evidence of higher stage disease by pelvic imaging within the past 2 years
  • Subjects with hydronephrosis, except for those subjects where hydronephrosis has been longstanding (i.e., predates the diagnosis of the CIS, Ta or T1 by more than 2 years) and diagnostic evaluation at screening shows no evidence of tumor
  • Any intravesicular or other chemotherapy treatment within 2 weeks or any investigational agent within 4 weeks prior to the initial dose of study drug
  • Current severe urinary tract infection or history of recurrent severe bacterial cystitis
  • Active, uncontrolled impairment of the urogenital, renal, hepatobiliary, cardiovascular, gastrointestinal, neurologic or hematopoietic systems which would predispose the subject to the development of complications from the administration of intravesical therapy and/or general anesthesia
  • History of other primary malignancy (other than squamous or basal cell skin cancers) that will require concomitant cancer therapy during the 24 months of the study
  • A QTc interval of >450 msec for males or > 470 msec for females at the screening ECG

Recruitment Status: Open

Brief Description Eligibility Contact Research Team

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