NCT02042781

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

An Open-label, Multi-centre Phase I Study of the Safety and Tolerability of IV Infused PG545 in Patients With Advanced Solid Tumours

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 23 (actual)
• Sponsor: Zucero Pty Ltd · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This Phase Ia study aims to establish the maximum tolerated dose of once-weekly IV infused 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 will be administered once weekly, as a one hour IV infusion. Patients will be treated until they exhibit disease progression, withdraw due to poor tolerability, or the study reaches its defined end-point. This study is a dose escalation study with doses of 25 mg to 250 mg anticipated.

Timeline

• Start date: 2014-01-01
• Primary completion: 2016-06-01
• Completion: 2016-09-01
• First posted: 2014-01-23
• Last updated: 2017-10-09

Locations

2 sites across 1 country: Australia