Clinical trial NCT02042781: Study of the Safety and Tolerability of IV Infused PG545 in Patients With Advanced Solid Tumours
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Advanced Solid Tumours
Keywords: PG545
Phase I
Progen
antimetastatic
antiangiogenic
advanced cancer patients
solid tumors
solid tumours
tumor microenvironment
Lead sponsor: Zucero Pty Ltd
Sponsor class: INDUSTRY
First posted: 2014-01-23
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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 spread.


Eligibility criteria: 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.

Primary outcomes:
measure: Determination of maximum tolerated dose (MTD) of PG545
timeFrame: Evaluated at the end of initial 28-day cycle
Secondary outcomes:
measure: Number of adverse events by cohort
timeFrame: Subjects will be followed for the duration of their treatment (an expected average of 12 weeks), and for four weeks post-treatment
measure: Severity of adverse events by cohort
timeFrame: Subjects will be followed for the duration of their treatment (an expected average of 12 weeks), and for four weeks post-treatment
measure: Assessment of the anti-tumour activity of PG545 using RECIST criteria
timeFrame: Subjects will be followed for the duration of their treatment (an expected average of 12 weeks), and then up to four weeks post-treatment
Other outcomes:
Locations:
city: Melbourne
country: Australia
facility: Nucleus Network Ltd
state: Victoria
city: Nedlands
country: Australia
facility: Linear Clinical Research Ltd
state: Western Australia
Study officials:
affiliation: Sir Charles Gairdner Hospital
name: Michael Millward, MBBS
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.