Advanced Solid TumoursPhase 1NCT01252095
Study of the Safety and Tolerability of PG545 in Patients With Advanced Solid Tumours
A Phase 1 study testing PG545 in people with Advanced Solid Tumours, run by Zucero Pty Ltd at 1 site in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Solid Tumours
- What is being tested?
- PG545
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteAustralia
- Study dates
- Jan 2011to Oct 2011
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- Written, signed and dated informed consent
- Able and willing to meet all protocol-required treatments, investigations and visits.
- Have adequate organ function
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
Australia1 site
Linear Clinical Research Ltd
Nedlands, Western Australia, 6009
About this study
Official title: An Open-label, Single Centre Phase I Study of the Safety and Tolerability of PG545 in Patients With Advanced Solid Tumours
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
- Being tested
- PG545
- Keywords
- PG545, Phase I, Progen, antimetastatic, antiangiogenic, advanced cancer patients, solid tumors, solid tumours
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PG545Drug
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.
| Study group | Role | What they receive |
|---|---|---|
| PG545 | Experimental | Not described Receives: Drug: PG545 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Following first 1 month cycle
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2010 (estimated)
- Study startJan 2011
- Primary completionOct 2011
- Study completionOct 2011
Why it stopped: Unexpected injection site reactions.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Advanced Solid TumoursStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zucero Pty Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Statistical Revelations Pty Ltd, Datapharm Australia Pty Ltd
- Responsible party
- Sponsor
- Investigators
- Michael Millward, MBBS, Principal investigator, Head of Department, Medical Oncology, Sir Charles Gairdner Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01252095
- Sponsor's protocol ID
- PG545101
- Status last verified
- Oct 2017
- First submitted
- 30 Nov 2010
- Last updated
- 9 Oct 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Single Centre Phase I Study of the Safety and Tolerability of PG545 in Patients With Advanced Solid Tumours
- ClinicalTrials.gov ID
- NCT01252095
- Acronym / sponsor ID
- PG545101
- Conditions
- Advanced Solid Tumours
- Keywords
- PG545, Phase I, Progen, antimetastatic, antiangiogenic, advanced cancer patients, solid tumors, solid tumours
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Unexpected injection site reactions.
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Zucero Pty LtdIndustry (pharma, biotech, devices)
- Collaborators
- Statistical Revelations Pty Ltd, Datapharm Australia Pty Ltd
- Study start
- Jan 2011
- Primary completion
- Oct 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 2 Dec 2010 (estimated)
- Results
- Posted 2 Aug 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PG545 | Experimental | Drug: PG545 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PG545PG545 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. | Drug | PG545 |
Primary outcome
Maximum Tolerated Dose (MTD) Based on DLT
Time frame: Following first 1 month cycle
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Millward, MBBS principal investigator
Head of Department, Medical Oncology, Sir Charles Gairdner Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing PG545 in people with Advanced Solid Tumours, run by Zucero Pty Ltd at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 9 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Aug 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum Tolerated Dose (MTD) Based on DLT (time frame: Following first 1 month cycle). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2017.