NCT02042781

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
23

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Jan 2014

Typical duration for phase_1

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2014

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

January 14, 2014

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 23, 2014

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2016

Completed
Last Updated

October 9, 2017

Status Verified

October 1, 2017

Enrollment Period

2.4 years

First QC Date

January 14, 2014

Last Update Submit

October 5, 2017

Conditions

Advanced Solid Tumours

Keywords

PG545Phase IProgenantimetastaticantiangiogenicadvanced cancer patientssolid tumorssolid tumourstumor microenvironment

Outcome Measures

Primary Outcomes (1)

  • 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.

    Evaluated at the end of initial 28-day cycle

Secondary Outcomes (3)

  • Number of adverse events by cohort

    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

    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

    Subjects will be followed for the duration of their treatment (an expected average of 12 weeks), and then up to four weeks post-treatment

Study Arms (1)

PG545

EXPERIMENTAL

Once weekly, one hour IV infusion of PG545.

Drug: PG545

Interventions

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.

PG545

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Nucleus Network Ltd

Melbourne, Victoria, 3004, Australia

Location

Linear Clinical Research Ltd

Nedlands, Western Australia, 6009, Australia

Location

Related Publications (1)

  • 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.

    PMID: 29898788DERIVED

Study Officials

  • Michael Millward, MBBS

    Sir Charles Gairdner Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 14, 2014

First Posted

January 23, 2014

Study Start

January 1, 2014

Primary Completion

June 1, 2016

Study Completion

September 1, 2016

Last Updated

October 9, 2017

Record last verified: 2017-10

Data Sharing

IPD Sharing
Will not share

Locations

AU(2)