A Continuation Protocol for Patients Previously Enrolled in a Study of Toca 511

Tocagen

Status and phase: Terminated; Phase 1

Conditions: Gliomas, Malignant; Glioblastoma Multiforme; Astrocytoma

Treatments: Drug: Toca FC • Flucytosine • 5-FC • 5-Fluorocytosine; Biological: Toca 511 vector

Study type: Interventional

Funder types: Industry

Identifiers

NCT04327011

Tg 511-09-01

Details and patient eligibility

About

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.

Enrollment: 65 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

65 participants in 1 patient group

Experimental

Experimental group

Description:

Single arm Toca 511 vector/5-FC prodrug

Treatment:

Biological: Toca 511 vector

Drug: Toca FC • Flucytosine • 5-FC • 5-Fluorocytosine