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An Open-label, Single Centre Phase I Study of the Safety and Tolerability of PG545 in Patients With Advanced Solid Tumours

Phase 1
18 Years
Not Enrolling
Advanced Solid Tumours

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Trial Information

An Open-label, Single Centre Phase I Study of the Safety and Tolerability of PG545 in Patients With Advanced Solid Tumours

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.

Type of Study:


Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Maximum Tolerated Dose (MTD) Based on DLT

Outcome Description:

The primary objective of this study is the determination of the MTD. Due to the premature termination of the study the MTD could not be determined. The outcome measure presented is the number of DLTs per cohort.

Outcome Time Frame:

Following first 1 month cycle

Safety Issue:


Principal Investigator

Michael Millward, MBBS

Investigator Role:

Principal Investigator

Investigator Affiliation:

Head of Department, Medical Oncology, Sir Charles Gairdner Hospital


Australia: Department of Health and Ageing Therapeutic Goods Administration

Study ID:




Start Date:

January 2011

Completion Date:

October 2011

Related Keywords:

  • Advanced Solid Tumours
  • PG545
  • Phase I
  • Progen
  • antimetastatic
  • antiangiogenic
  • advanced cancer patients
  • solid tumors
  • solid tumours
  • Neoplasms