Bladder Cancer Clinical Trial

Codex: Study of Inodiftagene Vixteplasmid (BC-819) in Unresponsive NMIBC

Summary

This study, BC-819-18-204, is a Phase 2, open-label, monotherapy, single-arm, multicenter clinical trial of BC-819 (inodiftagene vixteplasmid) in patients with NMIBC adequately treated with Bacillus Calmette-Guerin (BCG) whose disease is BCG unresponsive according to the US Food and Drug Administration (FDA) guidance.

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Full Description

BC-819 (inodiftagene vixteplasmid) is a recombinant DNA plasmid that directs the expression of a potent toxin specifically in malignant cells but not in normal tissue. It has been designed to exploit the established biology of the H19 gene, which is upregulated and expressed at high levels only in malignant cells, to produce bacterial diphtheria toxin only in bladder cancer tissue. BC-819 is administered directly into the bladder to enable maximal topical exposure to target bladder cancer cells.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Male or female patients ≥18 years of age at the time of consent

Patient must have been adequately treated with BCG defined as at least one of the following (FDA 2018):

At least five of six doses of an initial induction course plus at least two of three doses of maintenance therapy
At least five of six doses of an initial induction course plus at least two of six doses of a second induction course
A single course of induction BCG can qualify if the patient has T1 high-grade disease at first evaluation (see 3c)

Patient must be BCG-unresponsive defined as at least one of the following (FDA 2018):

Persistent or recurrent CIS alone or with recurrent Ta/T1 disease within 12 months of completion of adequate BCG therapy. An assessment within 15 months can also qualify when no assessment was done 12 months after completion of adequate BCG therapy.
Recurrent high-grade Ta/T1 disease within 6 months of completion of adequate BCG therapy. An assessment within 9 months can also qualify when no assessment was done 6 months after completion of adequate BCG therapy.
T1 high-grade disease at the first evaluation following a single course of induction BCG qualifies (Lerner et al. 2015, Steinberg et al. 2016)

Patient must have, at study entry, NMIBC indicated by 1 or more of the following:

Ta or T1 high-grade disease
CIS disease
Patient must have no known evidence of concomitant upper tract urothelial carcinoma or urothelial carcinoma within the prostatic urethra within 6 months of enrollment
Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status ≤2

Patient must have adequate hematologic function, as demonstrated by the following:

Hemoglobin level ≥10 g/dL
Absolute neutrophil count ≥1.5 x 109/L
Platelet count ≥100 x 109/L

Patient must have adequate liver and renal function as demonstrated by the following:

Aspartate aminotransferase and alanine aminotransferase each ≤3.0 x upper limit of normal
Total bilirubin ≤1.5 x upper limit of normal, unless prior documentation of Gilbert's syndrome in which case, 3.0 mg/dL is allowed
Serum creatinine ≤1.5 x upper limit of normal or measured or calculated creatinine clearance ≥30 mL/min
Female patients of childbearing potential must use maximally effective birth control during the period of therapy and for 1 month after the last study drug infusion
Male patients who are sexually active must be willing to use a double barrier contraceptive method upon study enrollment, during the course of the study, and for 1 month after the last study drug infusion

Exclusion Criteria:

Patient has current or previous evidence of muscle invasive (muscularis propria) or metastatic bladder cancer disease
Patient has received prior investigational therapy for NMIBC
Patient has received any therapy for NMIBC within 10 weeks before the start of study treatment other than surgical resection, 1 dose of chemotherapy, and previous BCG
Patient is intolerant to previous BCG treatment in the absence of meeting other criteria for BCG unresponsiveness and adequate BCG therapy
Patient has received external beam radiation therapy for bladder cancer at any time or for any other condition
Patient has an active infection, including urinary tract infection (viral, bacterial, or fungal) and cystitis
Patient has urinary tract signs or symptoms that preclude retention of drug in the bladder; this does not include anticholinergic drugs
Patient is known to have tested positive for human immunodeficiency virus (HIV). No HIV testing is required if patient is not known have tested positive
Patient is female and is pregnant or breastfeeding
Patient has a known presence or history of malignancy of other organ system within the 5 years before study start, with the exception of non-melanoma skin cancer; very low or low-risk prostate cancer; or patients who have been disease free for at least 2 years following stage 1 or 2 cancer

Study is for people with:

Bladder Cancer

Phase:

Phase 2

Estimated Enrollment:

32

Study ID:

NCT03719300

Recruitment Status:

Terminated

Sponsor:

Anchiano Therapeutics Israel Ltd.

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There are 45 Locations for this study

See Locations Near You

Alaska Urological Institute
Anchorage Alaska, 99503, United States
Banner MD Anderson Cancer Center
Gilbert Arizona, 85234, United States
Mayo Clinic Arizona
Phoenix Arizona, 85054, United States
Urological Associates of Southern Arizona
Tucson Arizona, 85715, United States
Arkansas Urology
Little Rock Arkansas, 72211, United States
American Institute of Research
Los Angeles California, 90017, United States
UC Davis Medical Center
Sacramento California, 95817, United States
The Urology Center of Colorado
Denver Colorado, 80211, United States
Mayo Clinic Florida
Jacksonville Florida, 32224, United States
University of Florida Health Jacksonville, Shands Hospital
Jacksonville Florida, 33209, United States
Emory University
Atlanta Georgia, 30322, United States
North Idaho Urology
Coeur d'Alene Idaho, 83814, United States
Idaho Urologic Institute, PA
Meridian Idaho, 83642, United States
University of Illinois Hospital and Health Systems (Outpatient Care Center)
Chicago Illinois, 60612, United States
The University of Kansas Cancer Center
Westwood Kansas, 66205, United States
Wichita Urology Group
Wichita Kansas, 67226, United States
Tulane University School of Medicine
New Orleans Louisiana, 70114, United States
Ochsner Clinical Foundation
New Orleans Louisiana, 70121, United States
Johns Hopkins Medical Institution
Baltimore Maryland, 21287, United States
Spectrum Health Medical Group
Grand Rapids Michigan, 49546, United States
Michigan Institute of Urology, PC
Troy Michigan, 48084, United States
Mayo Clinic
Rochester Minnesota, 55905, United States
Saint Louis University
Saint Louis Missouri, 63110, United States
Washington University
Saint Louis Missouri, 63110, United States
New Jersey Urology, LLC
Belleville New Jersey, 08043, United States
MD Anderson Cancer Center at Cooper
Voorhees New Jersey, 08103, United States
Albany Medical College
Albany New York, 12208, United States
Montefiore Medical Center
Bronx New York, 10461, United States
Weill Cornell Medical College - NY Presbyterian Hospital
New York New York, 10065, United States
SUNY Upstate Medical University
Syracuse New York, 13210, United States
UNC Chapel Hill Hospital, Urology Clinic
Chapel Hill North Carolina, 27514, United States
Duke University
Durham North Carolina, 27710, United States
Alliance Urology Specialists, PA
Greensboro North Carolina, 27403, United States
Carolina Urology Partners, PLLC
Huntersville North Carolina, 28078, United States
University of Toledo, Dept. of Urology and Kidney Transplant
Toledo Ohio, 43614, United States
University of Oklahoma Health Sciences Center
Oklahoma City Oklahoma, 73104, United States
MidLantic Urology
Bala-Cynwyd Pennsylvania, 19004, United States
The Hospital of the University of Pennsylvania
Philadelphia Pennsylvania, 19104, United States
Medical University South Carolina
Charleston South Carolina, 29425, United States
Regional Urology
Greenville South Carolina, 29605, United States
Urology Associates, P.C.
Nashville Tennessee, 37209, United States
University of Texas Southwestern Medical Center
Dallas Texas, 75390, United States
Baylor College of Medicine Medical Center
Houston Texas, 77030, United States
The Methodist Hospital d/b/a Houston Methodist Hospital
Houston Texas, 77030, United States
The University of Texas MD Anderson Cancer Center
Houston Texas, 77030, United States
Virginia Urology
Richmond Virginia, 23235, United States
Urology of Virginia
Virginia Beach Virginia, 23462, United States
West Virginia University Cancer Institute
Morgantown West Virginia, 26506, United States

How clear is this clinincal trial information?

Study is for people with:

Bladder Cancer

Phase:

Phase 2

Estimated Enrollment:

32

Study ID:

NCT03719300

Recruitment Status:

Terminated

Sponsor:


Anchiano Therapeutics Israel Ltd.

How clear is this clinincal trial information?

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