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

Advanced Solid Tumours Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02042781
• Other study ID #: PG545102
• Status: Completed
• Phase: Phase 1
• First received: January 14, 2014
• Last updated: October 5, 2017
• Start date: January 2014
• Est. completion date: September 2016

Study information

• Verified date: October 2017
• Source: Zucero Pty Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: September 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Advanced Solid Tumours
• Neoplasms

Intervention

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.

Locations

Country	Name	City	State
Australia	Nucleus Network Ltd	Melbourne	Victoria
Australia	Linear Clinical Research Ltd	Nedlands	Western Australia

Sponsors (1)

Lead Sponsor	Collaborator
Zucero Pty Ltd

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Determination of maximum tolerated dose (MTD) of PG545	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.	Evaluated at the end of initial 28-day cycle
Secondary	Number of adverse events by cohort		Subjects will be followed for the duration of their treatment (an expected average of 12 weeks), and for four weeks post-treatment
Secondary	Severity of adverse events by cohort		Subjects will be followed for the duration of their treatment (an expected average of 12 weeks), and for four weeks post-treatment
Secondary	Assessment of the anti-tumour activity of PG545 using RECIST criteria		Subjects will be followed for the duration of their treatment (an expected average of 12 weeks), and then up to four weeks post-treatment