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.

  • STATUS
    Recruiting
  • sponsor
    Viventia Bio
Updated on 2 September 2021
cancer
serum bilirubin
neutrophil count

Summary

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.

Description

Because of the high risk for development of muscle invasive disease, cystectomy is recommended for CIS, high-grade Ta and T1 patients who experience disease recurrence following intravesical therapy. Vicinium is an experimental agent that may provide an alternative to cystectomy.

Details
Condition Carcinoma, Advanced Malignancies, Vulvar Dysplasia and Carcinoma
Clinical Study IdentifierTX142703
SponsorViventia Bio
Last Modified on2 September 2021

Eligibility

Yes No Not Sure

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
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