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

This study has been terminated.
(Unexpected injection site reactions.)
Statistical Revelations Pty Ltd
Datapharm Australia Pty Ltd
Information provided by (Responsible Party):
Progen Pharmaceuticals Identifier:
First received: November 30, 2010
Last updated: June 26, 2012
Last verified: June 2012
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.

Condition Intervention Phase
Advanced Solid Tumours Drug: PG545 Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-label, Single Centre Phase I Study of the Safety and Tolerability of PG545 in Patients With Advanced Solid Tumours

Further study details as provided by Progen Pharmaceuticals:

Primary Outcome Measures:
  • Maximum Tolerated Dose (MTD) Based on DLT [ Time Frame: Following first 1 month cycle ]
    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.

Enrollment: 4
Study Start Date: January 2011
Study Completion Date: October 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PG545 Drug: PG545
PG545 Lyophilized Powder for Subcutaneous Injection. Patients will be dosed once weekly until they exhibit disease progression, are discontinued for reasons of tolerability, or the study reaches its defined end-point. This study is a dose escalation study with doses of 25 mg to 500 mg planned.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.
  Contacts and Locations
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Please refer to this study by its identifier: NCT01252095

Australia, Western Australia
Linear Clinical Research Ltd
Nedlands, Western Australia, Australia, 6009
Sponsors and Collaborators
Progen Pharmaceuticals
Statistical Revelations Pty Ltd
Datapharm Australia Pty Ltd
Principal Investigator: Michael Millward, MBBS Head of Department, Medical Oncology, Sir Charles Gairdner Hospital
  More Information

Responsible Party: Progen Pharmaceuticals Identifier: NCT01252095     History of Changes
Other Study ID Numbers: PG545101
Study First Received: November 30, 2010
Results First Received: May 21, 2012
Last Updated: June 26, 2012

Keywords provided by Progen Pharmaceuticals:
Phase I
advanced cancer patients
solid tumors
solid tumours

Additional relevant MeSH terms:
Neoplasms processed this record on August 17, 2017