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BRIEF TITLE: A Phase 2 Study of BC-819 in Patients With Non-Muscle Invasive Bladder Cancer Whose Disease is Unresponsive to Bacillus Calmette-Guerin

A Phase 2 Study of BC-819 in Patients With Non-Muscle Invasive Bladder Cancer Whose Disease is Unresponsive to Bacillus Calmette-Guerin


  • Org Study ID: BC-819-18-204
  • Secondary ID:
  • NCT ID: NCT03719300
  • NCT Alias:
  • Sponsor: Anchiano Therapeutics Israel Ltd. - Industry
  • Source: Anchiano Therapeutics Israel Ltd.

Brief 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.

Detailed 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.

Overal Status Start Date Phase Study Type
Recruiting December 11, 2018 Phase 2 Interventional

Primary Outcomes:

Primary Outcome 1 - Measure: Complete response rate

Primary Outcome 1 - Time Frame: 12-48 weeks

Condition:

  • Non-muscle Invasive Bladder Cancer (NMIBC)

Eligibility

Criteria:
Inclusion Criteria:

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

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

1. At least five of six doses of an initial induction course plus at least two of
three doses of maintenance therapy

2. At least five of six doses of an initial induction course plus at least two of
six doses of a second induction course

3. A single course of induction BCG can qualify if the patient has T1 high-grade
disease at first evaluation (see 3c)

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

1. 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.

2. 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.

3. T1 high-grade disease at the first evaluation following a single course of
induction BCG qualifies (Lerner et al. 2015, Steinberg et al. 2016)

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

1. Ta or T1 high-grade disease

2. CIS disease

5. Patient must have no known evidence of concomitant upper tract urothelial carcinoma or
urothelial carcinoma within the prostatic urethra within 6 months of enrollment

6. Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status ≤2

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

1. Hemoglobin level ≥10 g/dL

2. Absolute neutrophil count ≥1.5 x 109/L

3. Platelet count ≥100 x 109/L

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

1. Aspartate aminotransferase and alanine aminotransferase each ≤3.0 x upper limit
of normal

2. 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

3. Serum creatinine ≤1.5 x upper limit of normal or measured or calculated
creatinine clearance ≥30 mL/min

9. 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

10. 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:

1. Patient has current or previous evidence of muscle invasive (muscularis propria) or
metastatic bladder cancer disease

2. Patient has received prior investigational therapy for NMIBC

3. 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

4. Patient is intolerant to previous BCG treatment in the absence of meeting other
criteria for BCG unresponsiveness and adequate BCG therapy

5. Patient has received external beam radiation therapy for bladder cancer at any time or
for any other condition

6. Patient has an active infection, including urinary tract infection (viral, bacterial,
or fungal) and cystitis

7. Patient has urinary tract signs or symptoms that preclude retention of drug in the
bladder; this does not include anticholinergic drugs

8. 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

9. Patient is female and is pregnant or breastfeeding

10. 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
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Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Overall Contact

Name: Sean T Daly

Phone: 857-277-5577

Email: sean.daly@anchiano.com

Locations

Facility Status Contact
Banner MD Anderson Cancer Center
Gilbert, Arizona 85234
United States
Not yet recruiting
Mayo Clinic Arizona
Phoenix, Arizona 85054
United States
Not yet recruiting
Arkansas Urology
Little Rock, Arkansas 72211
United States
Not yet recruiting
UC Davis Medical Center
Sacramento, California 95817
United States
Not yet recruiting
University of Florida Health Jacksonville, Shands Hospital
Jacksonville, Florida 33209
United States
Not yet recruiting
North Idaho Urology
Coeur d'Alene, Idaho 83814
United States
Not yet recruiting
Idaho Urologic Institute, PA
Nampa, Idaho 83642
United States
Not yet recruiting
University of Illinois Cancer Center
Chicago, Illinois 60612
United States
Not yet recruiting
University of Kansas
Lawrence, Kansas 66045
United States
Not yet recruiting
Wichita Urology Group
Wichita, Kansas 67226
United States
Recruiting
Tulane University School of Medicine
New Orleans, Louisiana 70114
United States
Not yet recruiting
Ochsner Clinical Foundation
New Orleans, Louisiana 70121
United States
Recruiting
Johns Hopkins Medical Institution
Baltimore, Maryland 21287
United States
Not yet recruiting
Spectrum Health Medical Group
Grand Rapids, Michigan 49546
United States
Not yet recruiting
Michigan Institute of Urology, PC
Troy, Michigan 48084
United States
Not yet recruiting
Mayo Clinic
Rochester, Minnesota 55905
United States
Not yet recruiting
Saint Louis University
Saint Louis, Missouri 63110
United States
Not yet recruiting
Washington University
Saint Louis, Missouri 63110
United States
Not yet recruiting
New Jersey Urology, LLC
Belleville, New Jersey 08043
United States
Recruiting
MD Anderson Cancer Center at Cooper
Voorhees, New Jersey 08103
United States
Not yet recruiting
Albany Medical College
Albany, New York 12208
United States
Not yet recruiting
Montefiore Medical Center
Bronx, New York 10461
United States
Not yet recruiting
Weill Cornell Medical College - NY Presbyterian Hospital
New York, New York 10065
United States
Not yet recruiting
SUNY Upstate Medical University
Syracuse, New York 13210
United States
Not yet recruiting
Duke University
Durham, North Carolina 27710
United States
Not yet recruiting
Alliance Urology Specialists, PA
Greensboro, North Carolina 27403
United States
Not yet recruiting
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma 73104
United States
Recruiting
The Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania 19104
United States
Recruiting
Medical University South Carolina
Charleston, South Carolina 29425
United States
Not yet recruiting
Regional Urology
Greenville, South Carolina 29605
United States
Recruiting
Carolina Urology Partners, PLLC
West Columbia, South Carolina 29169
United States
Not yet recruiting
Urology Associates, P.C.
Nashville, Tennessee 37209
United States
Not yet recruiting
University of Texas Southwestern Medical Center
Dallas, Texas 75390
United States
Recruiting
Baylor College of Medicine Medical Center
Houston, Texas 77030
United States
Not yet recruiting
Virginia Urology
Richmond, Virginia 23235
United States
Not yet recruiting
Urology of Virginia
Virginia Beach, Virginia 23462
United States
Recruiting
West Virginia University Cancer Institute
Morgantown, West Virginia 26506
United States
Not yet recruiting