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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT01252095




Registration number
NCT01252095
Ethics application status
Date submitted
30/11/2010
Date registered
2/12/2010
Date last updated
9/10/2017

Titles & IDs
Public title
Study of the Safety and Tolerability of PG545 in Patients With Advanced Solid Tumours
Scientific title
An Open-label, Single Centre Phase I Study of the Safety and Tolerability of PG545 in Patients With Advanced Solid Tumours
Secondary ID [1] 0 0
PG545101
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Advanced Solid Tumours 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - PG545

Experimental: PG545 -


Treatment: Drugs: 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 code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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.
Timepoint [1] 0 0
Following first 1 month cycle

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
N/A
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 1
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Terminated
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 0 0
Linear Clinical Research Ltd - Nedlands
Recruitment postcode(s) [1] 0 0
6009 - Nedlands

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Zucero Pty Ltd
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Statistical Revelations Pty Ltd
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Datapharm Australia Pty Ltd
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/show/NCT01252095
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Michael Millward, MBBS
Address 0 0
Head of Department, Medical Oncology, Sir Charles Gairdner Hospital
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT01252095