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

Advanced Solid Tumours Clinical Trial

Official title:

An Open-label, Single Centre Phase I Study of the Safety and Tolerability of PG545 in Patients With Advanced Solid Tumours

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01252095
• Other study ID #: PG545101
• Status: Terminated
• Phase: Phase 1
• First received: November 30, 2010
• Last updated: October 5, 2017
• Start date: January 2011
• Est. completion date: October 2011

Study information

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

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 4
• Est. completion date: October 2011
• Est. primary completion date: October 2011
• 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.

• 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.

Related Conditions & MeSH terms

• Advanced Solid Tumours
• Neoplasms

Intervention

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.

Locations

Country	Name	City	State
Australia	Linear Clinical Research Ltd	Nedlands	Western Australia

Sponsors (3)

Lead Sponsor	Collaborator
Zucero Pty Ltd	Datapharm Australia Pty Ltd, Statistical Revelations Pty Ltd

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum Tolerated Dose (MTD) Based on DLT	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.	Following first 1 month cycle