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

• Status: Terminated
• Trial end date: 2011-10-01
• Target enrollment: 0
• Participant gender: All

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.

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

Details

• Lead Sponsor: Progen Pharmaceuticals; Zucero Pty Ltd
• Collaborators: Datapharm Australia Pty Ltd; Statistical Revelations 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.

• Measurable disease according to RECIST 1.1.

• Life expectancy >= 12 weeks

• ECOG Performance Status of 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

• History of immune-mediated thrombocytopaenia or other platelet abnormalities or other hereditary or acquired coagulopathies.

• Concomitant use of aspirin (> 150 mg/day), NSAIDs (except COX-2 selective inhibitors), vitamin K antagonists (other than low-dose prophylactic use), 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 virus (HIV)

• Women who are pregnant or breast-feeding.

• Women of child-bearing potential and male subjects who are partners of women of childbearing potential who are unable or unwilling to practice a highly effective means of contraception.

• Active substance abuse

• Subjects who have received an investigational agent within 28 days prior to Cycle 1 Day 1.