Study of the Safety and Tolerability of IV Infused PG545 in Patients With Advanced Solid Tumours

Zucero

Status and phase

Completed

Phase 1

Conditions

Advanced Solid Tumours

Treatments

Drug: PG545

Study type

Interventional

Funder types

Industry

Identifiers

NCT02042781

PG545102

Details and patient eligibility

About

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.

Enrollment

23 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.