Advanced Solid TumoursPhase 1NCT02042781
Study of the Safety and Tolerability of IV Infused 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 2 sites in Australia.
Trial 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… 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
- 23 participants
- Where
- 2 sitesAustralia
- Study dates
- Jan 2014to Sep 2016
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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.
- 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.
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
- 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.
Show all 10Show fewer
- 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.
Trial locations and contacts
2 sites in 1 country.
Australia2 sites
Nucleus Network Ltd
Melbourne, Victoria, 3004
Linear Clinical Research Ltd
Nedlands, Western Australia, 6009
About this study
Official title: An Open-label, Multi-centre Phase I Study of the Safety and Tolerability of IV Infused PG545 in Patients With Advanced Solid Tumours
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.
- Conditions
- Advanced Solid Tumours
- Being tested
- PG545
- Keywords
- PG545, Phase I, Progen, antimetastatic, antiangiogenic, advanced cancer patients, solid tumors, solid tumours, tumor microenvironment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PG545Drug
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.
| Study group | Role | What they receive |
|---|---|---|
| PG545 | Experimental | Once weekly, one hour IV infusion of PG545. Receives: Drug: PG545 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determination of maximum tolerated dose (MTD) of PG545
The MTD will be determined by assessing dose limiting toxicities at the end of the first month's treatment. Dose escalation and de-escalation will continue until an MTD is identified. Each cohort of patients will receive weekly doses at a single dose level for the duration of the study.
Measured: Evaluated at the end of initial 28-day cycle
Secondary outcomes (3)
Number of adverse events by cohort
Measured: Subjects will be followed for the duration of their treatment (an expected average of 12 weeks), and for four weeks post-treatment
Severity of adverse events by cohort
Measured: Subjects will be followed for the duration of their treatment (an expected average of 12 weeks), and for four weeks post-treatment
Assessment of the anti-tumour activity of PG545 using RECIST criteria
Measured: Subjects will be followed for the duration of their treatment (an expected average of 12 weeks), and then up to four weeks post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2014 (estimated)
- Study startJan 2014
- Primary completionJun 2016
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zucero Pty Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michael Millward, MBBS, Principal investigator, Sir Charles Gairdner Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02042781
- Sponsor's protocol ID
- PG545102
- Status last verified
- Oct 2017
- First submitted
- 14 Jan 2014
- Last updated
- 9 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Hammond E, Haynes NM, Cullinane C, Brennan TV, Bampton D, Handley P, Karoli T, Lanksheer F, Lin L, Yang Y, Dredge K. Immunomodulatory activities of pixatimod: emerging nonclinical and clinical data, and its potential utility in combination with PD-1 inhibitors. J Immunother Cancer. 2018 Jun 14;6(1):54. doi: 10.1186/s40425-018-0363-5.
PubMed 29898788
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, Multi-centre Phase I Study of the Safety and Tolerability of IV Infused PG545 in Patients With Advanced Solid Tumours
- ClinicalTrials.gov ID
- NCT02042781
- Acronym / sponsor ID
- PG545102
- 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
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Zucero Pty LtdIndustry (pharma, biotech, devices)
- Study start
- Jan 2014
- Primary completion
- Jun 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 23 Jan 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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: PG545Once weekly, one hour IV infusion of PG545. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (10 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
- 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.
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 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. | Drug | PG545 |
Primary outcome
Determination of maximum tolerated dose (MTD) of PG545
Time frame: Evaluated at the end of initial 28-day cycle
The MTD will be determined by assessing dose limiting toxicities at the end of the first month's treatment. Dose escalation and de-escalation will continue until an MTD is identified. Each cohort of patients will receive weekly doses at a single dose level for the duration of the study.
3 secondary outcomes
Number of adverse events by cohort
Time frame: Subjects will be followed for the duration of their treatment (an expected average of 12 weeks), and for four weeks post-treatment
Severity of adverse events by cohort
Time frame: Subjects will be followed for the duration of their treatment (an expected average of 12 weeks), and for four weeks post-treatment
Assessment of the anti-tumour activity of PG545 using RECIST criteria
Time frame: Subjects will be followed for the duration of their treatment (an expected average of 12 weeks), and then up to four weeks post-treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2017.
- Derived from this study: PubMed 29898788Hammond E, Haynes NM, Cullinane C, Brennan TV, Bampton D, Handley P, Karoli T, Lanksheer F, Lin L, Yang Y, Dredge K. Immunomodulatory activities of pixatimod: emerging nonclinical and clinical data, and its potential utility in combination with PD-1 inhibitors. J Immunother Cancer. 2018 Jun 14;6(1):54. doi: 10.1186/s40425-018-0363-5.
- Individual participant dataSharing planned: No
Related trials for Advanced Solid Tumours
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
Active, not recruitingPhase 1
A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK043 in Patients With Advanced Solid Tumor
Neoplasms
RecruitingPhase 1/2
A Study of Neladalkib (NVL-655) in Patients With Advanced NSCLC and Other Solid Tumors Harboring ALK Rearrangement or Activating ALK Mutation (ALKOVE-1)
Locally Advanced Solid Tumor, Metastatic Solid Tumor
Active, not recruitingPhase 2
Testing AZD5363 as a Potential Targeted Treatment in Cancers With AKT Genetic Changes (MATCH-Subprotocol Y)
Advanced Lymphoma, Advanced Malignant Solid Neoplasm
RecruitingPhase 1/2
Docetaxel and SX-682 in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma, Salivary Gland Carcinoma, and Advanced Prostate Cancer
Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma
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
Sir Charles Gairdner Hospital
2 sites 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 2 sites 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 8 inclusion and 10 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: finished, 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 2 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Determination of maximum tolerated dose (MTD) of PG545 (time frame: Evaluated at the end of initial 28-day cycle). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02042781, which also lists 1 linked publication.
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.