Trials / Completed
CompletedNCT02316171
CAVATAK (CVA21) in Non-muscle Invasive Bladder Cancer (VLA-012 CANON)
A Phase 1 Study to Evaluate the Safety and Clinical Activity of Intravesicular CAVATAK (Coxsackievirus A21, CVA21) Alone and in Sequential Combination With Low Dose Mitomycin C in Patients With Non-Muscle Invasive Bladder Cancer (VLA-012 CANON)
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 16 (actual)
- Sponsor
- Viralytics · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Detailed description
This was a Phase I, two-part, open-label, dose-escalation study designed to evaluate CVA21 alone and in sequential combination with low-dose mitomycin C in patients with non-muscle invasive bladder cancer (NMIBC) who were candidates for and were planning to undergo TUR for treatment of their disease. This gave a relatively homogeneous study population and facilitated collection of resected tumour tissue for histological, pharmacodynamics (PD) and pharmacokinetic (PK) analyses.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | CVA21 | CAVATAK is a purified preparation of CVA21 |
| DRUG | Mitomycin C | Chemotherapy |
Timeline
- Start date
- 2015-01-16
- Primary completion
- 2016-03-14
- Completion
- 2016-03-14
- First posted
- 2014-12-12
- Last updated
- 2022-07-27
- Results posted
- 2019-06-17
Locations
1 site across 1 country: United Kingdom
Source: ClinicalTrials.gov record NCT02316171. Inclusion in this directory is not an endorsement.