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

Phase 1

Completed

• Conditions: Advanced Solid Tumours
• Interventions: Drug: PG545

• Registration Number: NCT02042781
• Lead Sponsor: Zucero Pty Ltd

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-01
• Study First Submitted: 2014-01-14
• Study First Submitted QC: 2014-01-20
• Study First Posted: 2014-01-23
• Primary Completion: 2016-06
• Study Completion: 2016-09
• Status Verified: 2017-10
• Last Update Submitted: 2017-10-05
• Last Update Posted: 2017-10-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 23

Inclusion Criteria

• Age >=18 years.
• Histological or cytological documentation of non hematologic, malignant solid tumour.
• Have failed at least one previous therapeutic regimen.
• LIfe expectancy >= 12 weeks.
• ECOG performance status 0 or 1.
• Written, signed and dated informed consent.
• Able and willing to meet all protocol-required treatments, investigations and visits.
• Have adequate organ function.

Exclusion Criteria

• Clinically significant non-malignant disease.
• Active CNS metastases.
• Subjects with uncontrolled diabetes.
• History of clinically significant adverse drug reaction to heparin or other anti-coagulant agents
• Concomitant use of aspirin (> 150 mg/day), NSAIDs (except COX-2 selective inhibitors), vitamin K antagonists (other than low-dose), heparin within two weeks prior to randomisation, or other anti-platelet drugs.
• History of severe allergic, anaphylactic or other significant adverse reaction to radiographic contrast media.
• Known seropositivity to the human immunodeficiency vies (HIV)
• Women who are pregnant or breast feeding
• Women of child-bearing potential and male subjects who are partners of women of child bearing potential who are unable or unwilling to use effective means of contraception.
• Subjects who have received an investigational agent within 28 days prior to Cycle 1 Day 1.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
PG545	PG545	Once weekly, one hour IV infusion of PG545.

Primary Outcome Measures

Name	Time	Method
Determination of maximum tolerated dose (MTD) of PG545	Evaluated at the end of initial 28-day cycle	The MTD will be determined by assessing dose limiting toxicities at the end of the first month's treatment. Dose escalation and de-escalation will continue until an MTD is identified. Each cohort of patients will receive weekly doses at a single dose level for the duration of the study.

Secondary Outcome Measures

Name	Time	Method
Number of adverse events by cohort	Subjects will be followed for the duration of their treatment (an expected average of 12 weeks), and for four weeks post-treatment
Assessment of the anti-tumour activity of PG545 using RECIST criteria	Subjects will be followed for the duration of their treatment (an expected average of 12 weeks), and then up to four weeks post-treatment
Severity of adverse events by cohort	Subjects will be followed for the duration of their treatment (an expected average of 12 weeks), and for four weeks post-treatment

Trial Locations

Locations (2)

Nucleus Network Ltd; 🇦🇺 Melbourne, Victoria, Australia

Linear Clinical Research Ltd; 🇦🇺 Nedlands, Western Australia, Australia