Phase 1 N=16 Treatment

CAVATAK (CVA21) in Non-muscle Invasive Bladder Cancer (VLA-012 CANON)

Non-muscle Invasive Bladder Cancer

Bottom Line

View on ClinicalTrials.gov: NCT02316171 ↗

Enrolled (actual)

Serious AEs

6.7%

Results posted

Jun 2019

Primary outcome: Primary: Incidence of Dose-limiting Toxicities Treatment-related Adverse Events. — 9; 6 Participants

Study Design & Population

Study type: Interventional
Phase: Phase 1
Interventions: CVA21 (Biological); Mitomycin C (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Viralytics
Primary completion: Mar 2016

Outcome Measures

Outcome	Result	p-value
PRIMARY Incidence of Dose-limiting Toxicities Treatment-related Adverse Events.	9; 6	—

Summary

The study consisted of 2 sequential parts. Part A assessed the safety and tolerability of CAVATAK administered via intravesical instillation in patients with non-muscle invasive bladder cancer scheduled to undergo TUR. Part B assessed the safety and tolerability of CAVATAK administered in sequential combination with low dose Mitomycin C in the same patient population.

Eligibility Criteria

Inclusion Criteria

Clinical diagnosis of NMIBC based on cystoscopic appearance
ECOG 0-2
No intravesical therapy within 6 weeks of study entry
No prior radiation to the pelvis
ANC >1500/mm³; Hb >9.0 g/dL; Platelet >100000/mm³
Serum creatinine ≤ 1.5 mg/dL
Bilirubin within normal limits; AST ≤ 2.5x upper limit of normal (ULN); ALT ≤ 2.5 x ULN; alkaline phosphatase ≤ 2.5x ULN unless bone metastasis is present in the absence of liver metastasis
INR < 1.2; aPPT = 0.8-1.2; PT = 0.9-1.8
Candidate for TUR and planning to undergo TUR
Negative pregnancy test within 7 days of treatment start
Patients of child-bearing potential must agree to use an effective method of birth control

Exclusion Criteria

Prior local or systemic treatments for NMIBC
Concurrent treatment with any chemotherapeutic agent
Patients not deemed acceptable for general anaesthesia
Women who are pregnant or lactating
History of vesicoureteric reflux or an indwelling urinary stent
Administration of an investigational agent within 3 months of study entry
Active cardiac disease
Known infection with HIV, hepatitis B or C
Active uncontrolled infection

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02316171). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.