Study of the Safety and Tolerability of IV Infused PG545 in Patients With Advanced Solid Tumours
NCT ID: NCT02042781
Last Updated: 2017-10-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
23 participants
INTERVENTIONAL
2014-01-31
2016-09-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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PG545
Once weekly, one hour IV infusion of PG545.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Zucero Pty Ltd
INDUSTRY
Responsible Party
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Principal Investigators
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Michael Millward, MBBS
Role: PRINCIPAL_INVESTIGATOR
Sir Charles Gairdner Hospital
Locations
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Nucleus Network Ltd
Melbourne, Victoria, Australia
Linear Clinical Research Ltd
Nedlands, Western Australia, Australia
Countries
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References
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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.
Other Identifiers
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PG545102
Identifier Type: -
Identifier Source: org_study_id