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

• Status: Completed
• Trial end date: 2016-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Progen Pharmaceuticals; Zucero Pty Ltd

Criteria

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.