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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01252095
Recruitment Status : Terminated (Unexpected injection site reactions.)
First Posted : December 2, 2010
Results First Posted : August 2, 2012
Last Update Posted : October 9, 2017
Statistical Revelations Pty Ltd
Datapharm Australia Pty Ltd
Information provided by (Responsible Party):
Zucero Pty Ltd

Brief 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.

Condition or disease Intervention/treatment Phase
Advanced Solid Tumours Drug: PG545 Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4 participants
Allocation: N/A
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
Study Start Date : January 2011
Actual Primary Completion Date : October 2011
Actual Study Completion Date : October 2011

Arm Intervention/treatment
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.

Primary Outcome Measures :
  1. 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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01252095

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Australia, Western Australia
Linear Clinical Research Ltd
Nedlands, Western Australia, Australia, 6009
Sponsors and Collaborators
Zucero Pty Ltd
Statistical Revelations Pty Ltd
Datapharm Australia Pty Ltd
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Principal Investigator: Michael Millward, MBBS Head of Department, Medical Oncology, Sir Charles Gairdner Hospital
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Responsible Party: Zucero Pty Ltd Identifier: NCT01252095    
Other Study ID Numbers: PG545101
First Posted: December 2, 2010    Key Record Dates
Results First Posted: August 2, 2012
Last Update Posted: October 9, 2017
Last Verified: October 2017
Keywords provided by Zucero Pty Ltd:
Phase I
advanced cancer patients
solid tumors
solid tumours
Additional relevant MeSH terms:
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