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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT04327011
Other study ID # Tg 511-09-01
Secondary ID
Status Terminated
Phase Phase 1
First received
Last updated
Start date February 2011
Est. completion date December 2019

Study information

Verified date March 2020
Source Tocagen Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This is a multicenter, open-label, continuation study to allow subjects who have previously received Toca 511 to continue to receive Toca FC and to allow for extended safety observations. Subjects will be seen on an every six week basis for 1 year or longer. Subjects who continue to receive Toca FC will receive the dose described in the "parent" protocol. If the Toca FC dose is adjusted for any reason, the serum concentration will be monitored. Gadolinium (Gd)-enhanced magnetic resonance imaging (MRI) scans will be performed as per standard of care.

If the subject has recurred/progressed, repeat intracranial injection of Toca 511 followed by Toca FC treatment may be offered to consenting patients.

Subjects who enter the study to continue Toca FC and subsequently discontinue Toca FC, and subjects who are only willing or able to perform limited testing will have viral testing alone, at the appropriate intervals.

After the first year, subjects will be seen twice yearly for the next 4 years and then contacted yearly for the next 10 years.

All subjects will be followed on study for at least 5 years regardless of whether they are taking Toca FC.


Recruitment information / eligibility

Status Terminated
Enrollment 65
Est. completion date December 2019
Est. primary completion date December 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Informed Consent Form

- Subject received Toca 511 in prior study.

- Subject is willing to abide by protocol

Exclusion Criteria:

- Subject has history of allergy or intolerance to flucytosine

Study Design


Intervention

Biological:
Toca 511 vector
Toca 511 consists of a purified retroviral replicating vector encoding a modified yeast cytosine deaminase (CD) gene. The CD gene converts the antifungal 5-flurocytosine (5FC) to the anticancer drug 5-FU in cells that have been infected by the Toca 511 vector
Drug:
Toca FC • Flucytosine • 5-FC • 5-Fluorocytosine
Toca FC is an extended-release formulation of flucytosine.

Locations

Country Name City State
United States Cleveland Clinic Foundation Cleveland Ohio
United States Ohio State University Columbus Ohio
United States Henry Ford Health System Detroit Michigan
United States JFK Medical Center Neuroscience Institute Edison New Jersey
United States Hackensack University Medical Center Hackensack New Jersey
United States John Theurer Cancer Center at Hackensack University Hackensack New Jersey
United States University of California, Los Angeles Los Angeles California
United States University of Pittsburgh Medical Center Pittsburgh Pennsylvania
United States UCSD San Diego California
United States UCSF San Francisco California
United States Swedish Neuroscience Institute Seattle Washington

Sponsors (1)

Lead Sponsor Collaborator
Tocagen Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Other Progression-free survival in days from the initial Toca 511 administration on parent study to confirmed disease progression or death from any cause. from initial toca 511 administration to time of progression or death of any cause for up to 15 years.
Other Objective response rate from initial dose of Toca FC from the parent protocol Time from initial dose of Toca FC to death of last patient alive for up to 15 years.
Primary Long term safety follow up This will be based on treatment emergent adverse events, clinical laboratory values and viral testing. From study entry up to 15 years
Secondary Overall survival in days from the initial Toca 511 administration on parent study to the date of death. From initial Toca 511 administration to death of last patient alive for up to 15 years.
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