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

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

Study Description

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

Study Design

• 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

Arms and Interventions

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.

Outcome Measures

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 ]

Eligibility Criteria

• 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.

Contacts and Locations

Locations

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

• Principal Investigator: Michael Millward, MBBS; Sir Charles Gairdner Hospital

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Hammond E, Haynes NM, Cullinane C, Brennan TV, Bampton D, Handley P, Karoli T, Lanksheer F, Lin L, Yang Y, Dredge K. Immunomodulatory activities of pixatimod: emerging nonclinical and clinical data, and its potential utility in combination with PD-1 inhibitors. J Immunother Cancer. 2018 Jun 14;6(1):54. doi: 10.1186/s40425-018-0363-5.

• Responsible Party: Zucero Pty Ltd
• ClinicalTrials.gov Identifier: NCT02042781
• Other Study ID Numbers: PG545102
• First Posted: January 23, 2014
• 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:

Neoplasms