Study of the Safety and Tolerability of IV Infused PG545 in Patients With Advanced Solid Tumours
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ClinicalTrials.gov Identifier: NCT02042781 |
Recruitment Status :
Completed
First Posted : January 23, 2014
Last Update Posted : October 9, 2017
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Condition or disease | Intervention/treatment | Phase |
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Advanced Solid Tumours | Drug: PG545 | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 23 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
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 |
Study Start Date : | January 2014 |
Actual Primary Completion Date : | June 2016 |
Actual Study Completion Date : | September 2016 |
Arm | Intervention/treatment |
---|---|
Experimental: PG545
Once weekly, one hour IV infusion of PG545.
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Drug: 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. |
- 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.
- 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 ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02042781
Australia, Victoria | |
Nucleus Network Ltd | |
Melbourne, Victoria, Australia, 3004 | |
Australia, Western Australia | |
Linear Clinical Research Ltd | |
Nedlands, Western Australia, Australia, 6009 |
Principal Investigator: | Michael Millward, MBBS | Sir Charles Gairdner Hospital |
Responsible Party: | Zucero Pty Ltd |
ClinicalTrials.gov Identifier: | NCT02042781 |
Other Study ID Numbers: |
PG545102 |
First Posted: | January 23, 2014 Key Record Dates |
Last Update Posted: | October 9, 2017 |
Last Verified: | October 2017 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
PG545 Phase I Progen antimetastatic antiangiogenic |
advanced cancer patients solid tumors solid tumours tumor microenvironment |
Neoplasms |