Ignite Creation Date:
2025-12-24 @ 1:59 PM
Ignite Modification Date:
2026-01-01 @ 6:20 AM
Study NCT ID:
NCT01252095
Status:
TERMINATED
Last Update Posted:
2017-10-09
First Post:
2010-11-30
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study of the Safety and Tolerability of PG545 in Patients With Advanced Solid Tumours
Sponsor:
Zucero Pty Ltd
Organization:
Study Overview
Official Title:
An Open-label, Single Centre Phase I Study of the Safety and Tolerability of PG545 in Patients With Advanced Solid Tumours
Status:
TERMINATED
Status Verified Date:
2017-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Unexpected injection site reactions.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This first-in-human study aims to establish the maximum tolerated dose of PG545 and to evaluate its safety in subjects with advanced solid tumours. In addition the study will explore whether PG545 exposure results in changes to chemicals produced by the body that are associated with cancer growth and spread.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: