An Open-label, Single Centre Phase I Study of the Safety and Tolerability of PG545 in Patients With Advanced Solid Tumours
- 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
- Clinically significant non-malignant disease.
- Active CNS metastases.
- Subjects with uncontrolled diabetes.
- History of clinically significant adverse drug reaction to heparin or other
- 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