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

NCT01252095 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 4

Last updated 2017-10-09

Study results available
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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

Interventions

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.

Sponsors & Collaborators

  • Statistical Revelations Pty Ltd

    collaborator UNKNOWN

  • Datapharm Australia Pty Ltd

    collaborator UNKNOWN

  • Zucero Pty Ltd

    lead INDUSTRY

Principal Investigators

  • Michael Millward, MBBS · Head of Department, Medical Oncology, Sir Charles Gairdner Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-01-31
Primary Completion
2011-10-31
Completion
2011-10-31

Countries

  • Australia

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01252095 on ClinicalTrials.gov