Trials / Withdrawn
WithdrawnNCT04089163
A Study of Toca 511 & Toca FC in Patients With Recurrent High Grade Non-Muscle Invasive Bladder Cancer (Toca 8)
Toca 8: A Multicenter, Open-Label, Phase 1 Study to Evaluate the Safety and Tolerability of Toca 511, a Retroviral Replicating Vector, Combined With Toca FC in Patients With Recurrent High Grade Non-Muscle Invasive Bladder Cancer
- Status
- Withdrawn
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 0 (actual)
- Sponsor
- Tocagen Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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 the recommended Phase 2 dose. Patients with recurrent HG NMIBC who are undergoing planned transurethral resection of bladder tumor (TURBT) will be enrolled into the study, subject to meeting all entry criteria.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Toca 511 | Toca 511 consists of a purified retroviral replicating vector encoding a modified yeast cytosine deaminase (CD) gene. The CD gene converts the antifungal drug, flucytosine (5-fluorocytosine; 5-FC) to the anticancer drug 5-fluorouracil (5-FU) in cancer cells that have been infected by the Toca 511 vector. |
| DRUG | Toca FC (extended-release formulation of flucytosine) | Toca FC is an extended-release formulation of flucytosine and is supplied as 500 mg tablets |
Timeline
- Start date
- 2019-12-01
- Primary completion
- 2022-01-01
- Completion
- 2027-01-01
- First posted
- 2019-09-13
- Last updated
- 2020-03-30
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04089163. Inclusion in this directory is not an endorsement.