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

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ClinicalTrials.gov Identifier: NCT02042781
Recruitment Status : Completed
First Posted : January 23, 2014
Last Update Posted : October 9, 2017
Sponsor:
Information provided by (Responsible Party):
Zucero Pty Ltd

Brief Summary:
This Phase Ia study aims to establish the maximum tolerated dose of once-weekly IV infused 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 : 23 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-label, Multi-centre Phase I Study of the Safety and Tolerability of IV Infused PG545 in Patients With Advanced Solid Tumours
Study Start Date : January 2014
Actual Primary Completion Date : June 2016
Actual Study Completion Date : September 2016

Arm Intervention/treatment
Experimental: PG545
Once weekly, one hour IV infusion of PG545.
Drug: PG545
PG545 will be administered once weekly, as a one hour IV infusion. Patients will be treated until they exhibit disease progression, withdraw due to poor tolerability, or the study reaches its defined end-point. This study is a dose escalation study with doses of 25 mg to 250 mg anticipated.




Primary Outcome Measures :
  1. Determination of maximum tolerated dose (MTD) of PG545 [ Time Frame: Evaluated at the end of initial 28-day cycle ]
    The MTD will be determined by assessing dose limiting toxicities at the end of the first month's treatment. Dose escalation and de-escalation will continue until an MTD is identified. Each cohort of patients will receive weekly doses at a single dose level for the duration of the study.


Secondary Outcome Measures :
  1. Number of adverse events by cohort [ Time Frame: Subjects will be followed for the duration of their treatment (an expected average of 12 weeks), and for four weeks post-treatment ]
  2. Severity of adverse events by cohort [ Time Frame: Subjects will be followed for the duration of their treatment (an expected average of 12 weeks), and for four weeks post-treatment ]
  3. Assessment of the anti-tumour activity of PG545 using RECIST criteria [ Time Frame: Subjects will be followed for the duration of their treatment (an expected average of 12 weeks), and then up to four weeks post-treatment ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.
  • LIfe expectancy >= 12 weeks.
  • ECOG performance status 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
  • Concomitant use of aspirin (> 150 mg/day), NSAIDs (except COX-2 selective inhibitors), vitamin K antagonists (other than low-dose), 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 vies (HIV)
  • Women who are pregnant or breast feeding
  • Women of child-bearing potential and male subjects who are partners of women of child bearing potential who are unable or unwilling to use effective means of contraception.
  • 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 ClinicalTrials.gov identifier (NCT number): NCT02042781


Locations
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Australia, Victoria
Nucleus Network Ltd
Melbourne, Victoria, Australia, 3004
Australia, Western Australia
Linear Clinical Research Ltd
Nedlands, Western Australia, Australia, 6009
Sponsors and Collaborators
Zucero Pty Ltd
Investigators
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Principal Investigator: Michael Millward, MBBS Sir Charles Gairdner Hospital
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Zucero Pty Ltd
ClinicalTrials.gov Identifier: NCT02042781    
Other Study ID Numbers: PG545102
First Posted: January 23, 2014    Key Record Dates
Last Update Posted: October 9, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Zucero Pty Ltd:
PG545
Phase I
Progen
antimetastatic
antiangiogenic
advanced cancer patients
solid tumors
solid tumours
tumor microenvironment
Additional relevant MeSH terms:
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Neoplasms