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

This study has been terminated.
(Unexpected injection site reactions.)
Sponsor:
Collaborators:
Statistical Revelations Pty Ltd
Datapharm Australia Pty Ltd
Information provided by (Responsible Party):
Progen Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01252095
First received: November 30, 2010
Last updated: June 26, 2012
Last verified: June 2012
  Purpose

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: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


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 ] [ Designated as safety issue: Yes ]
    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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01252095

Locations
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
Investigators
Principal Investigator: Michael Millward, MBBS Head of Department, Medical Oncology, Sir Charles Gairdner Hospital
  More Information

No publications provided

Responsible Party: Progen Pharmaceuticals
ClinicalTrials.gov 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
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration

Keywords provided by Progen Pharmaceuticals:
PG545
Phase I
Progen
antimetastatic
antiangiogenic
advanced cancer patients
solid tumors
solid tumours

Additional relevant MeSH terms:
Neoplasms

ClinicalTrials.gov processed this record on July 24, 2014