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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT02042781




Registration number
NCT02042781
Ethics application status
Date submitted
14/01/2014
Date registered
23/01/2014
Date last updated
9/10/2017

Titles & IDs
Public title
Study of the Safety and Tolerability of IV Infused PG545 in Patients With Advanced Solid Tumours
Scientific title
An Open-label, Multi-centre Phase I Study of the Safety and Tolerability of IV Infused PG545 in Patients With Advanced Solid Tumours
Secondary ID [1] 0 0
PG545102
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 - Once weekly, one hour IV infusion of PG545.


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

Outcomes
Primary outcome [1] 0 0
Determination of maximum tolerated dose (MTD) of PG545
Timepoint [1] 0 0
Evaluated at the end of initial 28-day cycle
Secondary outcome [1] 0 0
Number of adverse events by cohort
Timepoint [1] 0 0
Subjects will be followed for the duration of their treatment (an expected average of 12 weeks), and for four weeks post-treatment
Secondary outcome [2] 0 0
Severity of adverse events by cohort
Timepoint [2] 0 0
Subjects will be followed for the duration of their treatment (an expected average of 12 weeks), and for four weeks post-treatment
Secondary outcome [3] 0 0
Assessment of the anti-tumour activity of PG545 using RECIST criteria
Timepoint [3] 0 0
Subjects will be followed for the duration of their treatment (an expected average of 12 weeks), and then up to four weeks post-treatment

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.

- 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.
Minimum age
18 Years
Maximum age
No limit
Sex
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

- 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.

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
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/01/2014
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/09/2016
Sample size
Target
Accrual to date
Final
23
Recruitment in Australia
Recruitment state(s)
VIC,WA
Recruitment hospital [1] 0 0
Nucleus Network Ltd - Melbourne
Recruitment hospital [2] 0 0
Linear Clinical Research Ltd - Nedlands
Recruitment postcode(s) [1] 0 0
3004 - Melbourne
Recruitment postcode(s) [2] 0 0
6009 - Nedlands

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Zucero Pty Ltd
Address
Country

Ethics approval
Ethics application status

Summary
Brief 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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT02042781
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Michael Millward, MBBS
Address 0 0
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