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

NCT ID: NCT01252095

Last Updated: 2017-10-09

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 4 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-01-31
• Study Completion Date: 2011-10-31

Brief 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.

Conditions

Advanced Solid Tumours

Keywords

PG545; Phase I; Progen; antimetastatic; antiangiogenic; advanced cancer patients; solid tumors; solid tumours

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

PG545

Group Type: EXPERIMENTAL

PG545

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Statistical Revelations Pty Ltd

UNKNOWN

Sponsor Role: collaborator

Datapharm Australia Pty Ltd

UNKNOWN

Sponsor Role: collaborator

Zucero Pty Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michael Millward, MBBS

Role: PRINCIPAL_INVESTIGATOR

Head of Department, Medical Oncology, Sir Charles Gairdner Hospital

Locations

Linear Clinical Research Ltd

Nedlands, Western Australia, Australia

Countries

Australia

Other Identifiers

PG545101

Identifier Type: -

Identifier Source: org_study_id