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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT02042781
Ethics application status
Date submitted
14/01/2014
Date registered
23/01/2014

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
NA
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
Trial website
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

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT02042781