A Phase 1 Study of Epidermal Growth Factor Receptor (EGFR) Targeted, PaclitaxelLoaded EnGeneIC Delivery Vehicles (Erbitux®EDVsPac) in Patients with Advanced SolidTumours

Phase 1

Completed

• Conditions: Advanced Solid Tumours; Cancer - Other cancer types

• Registration Number: ACTRN12609000672257
• Lead Sponsor: EnGeneIC Pty Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-08-06
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 32

Inclusion Criteria

Patients with advanced solid tumours that are metastatic or unresectable. Patients must have tumour types known to express EGFR.

Exclusion Criteria

Previous treatment with taxanes, treatment with EGFR inhibitor or other chemotherapy or radiotherapy in past 30 days, salmonella vaccination in past 12 months, hypersensitivity to monoclonal antibodies or taxanes, uncontrolled brain metastases

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Safety which will be assessed based on the incidence and severity of reported Adverse Events and Serious Adverse Events.[Spontaneously reported adverse events may be reported at any time after the first administration of study treatment. Adverse events will also be elicited at 4 hours after each dose administration and up to 30 days after the last dose.]

Secondary Outcome Measures

Name	Time	Method
Immune and Inflammatory response will be assessed by measuring the serum levels of a range of cytokines.[At 4 and 24 hours after administration of each dose of study treatment];Tumour Response using computed tomography (CT scan) and positron emission tomography (PET scan).[At the end of each 6 week cycle]