Status:
WITHDRAWN
A Study of Toca 511 & Toca FC in Patients With Recurrent High Grade Non-Muscle Invasive Bladder Cancer (Toca 8)
Lead Sponsor:
Tocagen Inc.
Conditions:
Bladder Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
This is a Phase 1, multicenter, open-label study of intravesical Toca 511 followed by oral Toca FC in patients with high grade (HG) non-muscle invasive bladder cancer (NMIBC), with cohort expansion at...
Eligibility Criteria
Inclusion
- Provide written informed consent to participate
- At least 18 years of age
- Recurrent HG NMIBC, with HG tumor on previous histopathology
- Undergoing planned TURBT and biopsy of CIS suspicious areas
- No imaging findings consistent with T2 or greater disease, hydronephrosis, extravesical disease, nodal involvement, metastases, or other malignancies.
- Able and willing to wait at least 2 weeks following intravesical administration of Toca 511 to undergo TURBT
- If patient is a candidate for standard of care (SOC) intravesical therapy, able and willing to wait at least 2 weeks post-TURBT for initiation of such treatment
- Patient is able to be catheterized and is anticipated to be able to retain Toca 511 for approximately 2 hours
- Estimated life expectancy of at least 12 months
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1
- Patient has adequate organ function, as indicated by the following laboratory values
- Complete blood count: hemoglobin ≥ 10 g/dL, platelet count ≥ 100,000/mm\^3, absolute neutrophil count ≥ 1,500/ mm\^3, absolute lymphocyte count ≥ 500/ mm\^3
- Liver: total bilirubin ≤ 1.5 × the upper limit of normal (ULN; unless known Gilbert's syndrome); alanine aminotransferase ≤ 2.5 × ULN
- Kidney: estimated glomerular filtration rate (GFR: Cockcroft-Gault) ≥ 50 mL/min
- Women of childbearing potential (defined as not postmenopausal \[ie, ≥ 12 months of non-therapy-induced amenorrhea\] or not surgically sterile) must have a negative serum pregnancy test within 7 days prior to administration of Toca 511, and be willing to use an effective means of contraception in addition to barrier methods (condoms) for the duration of the study.
- Patient and partner are willing to use condoms for 12 months after receiving Toca 511 and/or 30 days after the last dose of Toca FC, and/or until there is no evidence of the virus in his/her blood or urine, whichever is longer.
Exclusion
- History of urothelial cancer in the upper tract or urethra; muscle invasive bladder cancer; or metastatic bladder cancer
- History of bladder tumors other than urothelial carcinoma (ie, neuroendocrine, adenocarcinoma, or squamous cell carcinoma)
- Treatment with intravesical agents within 28 days prior to Toca 511 administration
- TURBT within 12 weeks prior to planned Toca 511 administration
- History of pelvic radiation
- Bladder tumor located within a bladder diverticulum
- Genitourinary procedures (eg, prostate surgery; treatment of ureteral stones or moderate to extensive urethral stricture disease) prior to, during, or planned within the 4 weeks following TURBT, other than procedures for treatment of bladder tumors
- Severe lower urinary tract dysfunction clinically manifest as poor capacity, disabling incontinence, chronic catheter use, or chronic infections or stones
- Presence of suprapubic catheter
- History of other malignancy, unless the patient has been disease-free for at least 5 years. Adequately treated basal cell carcinoma or squamous cell skin cancer is acceptable regardless of time, as well as cervical carcinoma in situ or localized prostate carcinoma, after curative treatment. (Note: Men with very low or low risk prostate cancer on active surveillance are acceptable candidates for this study.)
- Active infection requiring antibiotic, antifungal, or antiviral therapy within 2 weeks prior to administration of Toca 511
- Investigational treatment within 2 weeks or immunotherapy or antibody therapy within 28 days prior to Toca 511 administration, and/or has not recovered from toxicities associated with such treatment
- Chronic treatment with autoimmune medications
- Human immunodeficiency virus (HIV) seropositive
- Pregnant or breast feeding
- Bleeding diathesis, or required to take anticoagulants or antiplatelet agents, including nonsteroidal anti-inflammatory drugs, that cannot be stopped for surgery
- Severe pulmonary, cardiac, or other systemic disease, specifically:
- New York Heart Association \> Class II congestive heart failure that is not controlled on standard therapy within 6 months prior to Toca 511 administration
- Uncontrolled or significant cardiovascular disease, clinically significant ventricular arrhythmia (such as ventricular tachycardia, ventricular fibrillation, or torsades de pointes), clinically significant pulmonary disease (such as ≥ Grade 2 dyspnea)
- Any other serious medical, social, or psychological condition that, based on Investigator assessment, may affect the patient's compliance or place the patient at an increased risk of potential treatment complications
- History of allergy or intolerance to flucytosine
- Presence of a condition that would prevent the patient from being able to swallow Toca FC tablets
Key Trial Info
Start Date :
December 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2027
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04089163
Start Date
December 1 2019
End Date
January 1 2027
Last Update
March 30 2020
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