NCT01252095

Study of the Safety and Tolerability of PG545 in Patients With Advanced Solid Tumours

An Open-label, Single Centre Phase I Study of the Safety and Tolerability of PG545 in Patients With Advanced Solid Tumours

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 4 (actual)
• Sponsor: Zucero Pty Ltd · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Advanced Solid Tumours

Interventions

Type	Name	Description
DRUG	PG545	PG545 Lyophilized Powder for Subcutaneous Injection. Patients will be dosed once weekly until they exhibit disease progression, are discontinued for reasons of tolerability, or the study reaches its defined end-point. This study is a dose escalation study with doses of 25 mg to 500 mg planned.

Timeline

• Start date: 2011-01-01
• Primary completion: 2011-10-01
• Completion: 2011-10-01
• First posted: 2010-12-02
• Last updated: 2017-10-09
• Results posted: 2012-08-02

Locations

1 site across 1 country: Australia