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Completed

NCT Number: NCT02042781

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Nucleus Network Ltd, Melbourne, Victoria, Australia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

PG545

Drug

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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Zucero Pty Ltd

Industry

Registry information

Official study title

An Open-label, Multi-centre Phase I Study of the Safety and Tolerability of IV Infused PG545 in Patients With Advanced Solid Tumours

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Jan 23, 2014
Registry last updated
Oct 9, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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