Title

Study of the Safety and Tolerability of PG545 in Patients With Advanced Solid Tumours
An Open-label, Single Centre Phase I Study of the Safety and Tolerability of PG545 in Patients With Advanced Solid Tumours
  • Phase

    Phase 1
  • Study Type

    Interventional
  • Intervention/Treatment

    pg545 ...
  • Study Participants

    4
This first-in-human study aims to establish the maximum tolerated dose of 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 Started
Jan 31
2011
Primary Completion
Oct 31
2011
Study Completion
Oct 31
2011
Results Posted
Aug 02
2012
Estimate
Last Update
Oct 09
2017

Drug PG545

PG545 Lyophilized Powder for Subcutaneous Injection. Patients will be dosed once weekly until they exhibit disease progression, are discontinued for reasons of tolerability, or the study reaches its defined end-point. This study is a dose escalation study with doses of 25 mg to 500 mg planned.

PG545 Experimental

Criteria

Inclusion Criteria:

Age >=18 years.
Histological or cytological documentation of non hematologic, malignant solid tumour.
Have failed at least one previous therapeutic regimen.
Measurable disease according to RECIST 1.1.
Life expectancy >= 12 weeks
ECOG Performance Status of 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
History of immune-mediated thrombocytopaenia or other platelet abnormalities or other hereditary or acquired coagulopathies.
Concomitant use of aspirin (> 150 mg/day), NSAIDs (except COX-2 selective inhibitors), vitamin K antagonists (other than low-dose prophylactic use), 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 virus (HIV)
Women who are pregnant or breast-feeding.
Women of child-bearing potential and male subjects who are partners of women of childbearing potential who are unable or unwilling to practice a highly effective means of contraception.
Active substance abuse
Subjects who have received an investigational agent within 28 days prior to Cycle 1 Day 1.

Summary

25 mg Dose

50 mg Dose

All Events

Event Type Organ System Event Term 25 mg Dose 50 mg Dose

Maximum Tolerated Dose (MTD) Based on DLT

The primary objective of this study is the determination of the MTD. Due to the premature termination of the study the MTD could not be determined. The outcome measure presented is the number of DLTs per cohort.

25 mg Dose

50 mg Dose

1.0
DLTs

Total

4
Participants

Age, Continuous

62
years (Mean)
Standard Deviation: 5

Age, Categorical

Region of Enrollment

Sex: Female, Male

Overall Study

25 mg Dose

50 mg Dose

Drop/Withdrawal Reasons

25 mg Dose