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

NCT01252095 | Terminated Phase 1 Results DMC

• 1 other identifier: PG545101
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Advanced Solid Tumours

Keywords

PG545; Phase I; Progen; antimetastatic; antiangiogenic; advanced cancer patients; solid tumors; solid tumours

Outcome Measures

Primary Outcomes (1)

• 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.

  Following first 1 month cycle

Study Arms (1)

PG545

EXPERIMENTAL

Drug: PG545

Interventions

PG545 DRUG

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (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.
• 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

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
• 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.

Sponsors & Collaborators

• Zucero Pty Ltd: lead
• Statistical Revelations Pty Ltd: collaborator
• Datapharm Australia Pty Ltd: collaborator

Study Sites (1)

Linear Clinical Research Ltd

Nedlands, Western Australia, 6009, Australia

Location

Limitations and Caveats

Early termination due to unexpected injection site reactions leading to small numbers of subjects analyzed. An MTD could not be determined for this study.

Results Point of Contact

• Title: Director of Clinical Development
• Organization: Progen Pharmaceuticals Ltd

+61 7 32739133

Study Officials

• Michael Millward, MBBS

  Head of Department, Medical Oncology, Sir Charles Gairdner Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

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: November 30, 2010
• First Posted: December 2, 2010
• Study Start: January 1, 2011
• Primary Completion: October 1, 2011
• Study Completion: October 1, 2011
• Last Updated: October 9, 2017
• Results First Posted: August 2, 2012

Record last verified: 2017-10

Locations

AU (1)