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Trial registered on ANZCTR


Registration number
ACTRN12609000672257
Ethics application status
Approved
Date submitted
11/02/2009
Date registered
6/08/2009
Date last updated
8/10/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
A Phase 1 Study of Epidermal Growth Factor Receptor (EGFR) Targeted, Paclitaxel
Loaded EnGeneIC Delivery Vehicles (Erbitux®EDVsPac) in Patients with Advanced Solid
Tumours
Scientific title
A Phase 1 Study of Epidermal Growth Factor Receptor (EGFR) Targeted, Paclitaxel Loaded EnGeneIC Delivery Vehicles in Patients with Advanced Solid Tumours
Secondary ID [1] 252738 0
ENG1
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Advanced Solid Tumours 4316 0
Condition category
Condition code
Cancer 4550 4550 0 0
Other cancer types

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
EGFR targeted, Paclitaxel loaded EnGeneIC Delivery Vehicle (EDV) An EDV is an anucleate bacterially derived minicell. EDVs can be loaded with chemotherapy, in this case paclitaxel. The EDV is coated with EGFR antibodies to enable it to attach to cancer cells. The EDVs are administered by intravenous infusion. This is a dose escalation study with potentially 6 levels. The doses are stated as number of EDVs given. The starting dose is 1X10e8 EDVs and increasing to a maximum of 2X10e11 EDVs. Each dose is given as a 20mL injection administered slowly over a period of 20 minutes. Patients are treated in cycles of 5 infusions administered at weekly intervals, separated by a treatment free week. Patients may continue in the study if their tumor is stable or responding. Patients with progressive disease may be able to continue treatment if there are no other proven treatment options available to them
Intervention code [1] 4046 0
Treatment: Drugs
Comparator / control treatment
None
Control group
Uncontrolled

Outcomes
Primary outcome [1] 5429 0
Safety which will be assessed based on the incidence and severity of reported Adverse Events and Serious Adverse Events.
Timepoint [1] 5429 0
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 [1] 9124 0
Immune and Inflammatory response will be assessed by measuring the serum levels of a range of cytokines.
Timepoint [1] 9124 0
At 4 and 24 hours after administration of each dose of study treatment
Secondary outcome [2] 9125 0
Tumour Response using computed tomography (CT scan) and positron emission tomography (PET scan).
Timepoint [2] 9125 0
At the end of each 6 week cycle

Eligibility
Key inclusion criteria
Patients with advanced solid tumours that are metastatic or unresectable. Patients must have tumour types known to express EGFR.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other design features
Dose Escalation
Phase
Phase 1
Type of endpoint(s)
Safety
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment postcode(s) [1] 1488 0
3002
Recruitment postcode(s) [2] 1489 0
3050

Funding & Sponsors
Funding source category [1] 4488 0
Commercial sector/Industry
Name [1] 4488 0
EnGeneIc Pty Ltd
Address [1] 4488 0
Building 2, 25 Sirius Rd
Lane Cove NSW 2066
Country [1] 4488 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
EnGeneIC Pty Ltd
Address
Building 2, 25 Sirius Rd
Lane Cove NSW 2066
Country
Australia
Secondary sponsor category [1] 4052 0
None
Name [1] 4052 0
Address [1] 4052 0
Country [1] 4052 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6549 0
Peter MacCallum Cancer Centre Ethics Committee
Ethics committee address [1] 6549 0
St Andrews Place
EAST MELBOURNE VIC 3002
Ethics committee country [1] 6549 0
Australia
Date submitted for ethics approval [1] 6549 0
16/02/2009
Approval date [1] 6549 0
14/07/2009
Ethics approval number [1] 6549 0
9/01/2009

Summary
Brief summary
This study looks at treatment with a targeted biological therapy (Epidermal Growth Factor Receptor [EGFR] Targeted, Paclitaxel Loaded EnGeneIC Delivery Vehicles [ErbituxEDVsPac]) in people with advanced epithelial cancer.

Who is it for?
You can join this study if you have: – advanced epithelial cancer which has spread to secondary or distant sites or cannot be removed by surgery – a tumour type known to express EGFR.

Trial details
All participants will receive ErbituxEDVsPac Dose at increasing doses. The study will monitor the safety and effectiveness of treatment, in particular the immune and inflammatory response (measured after each treatment) and the tumour response (measured after each six week cycle of treatment).
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29276 0
Address 29276 0
Country 29276 0
Phone 29276 0
Fax 29276 0
Email 29276 0
Contact person for public queries
Name 12523 0
Dr Jennifer MacDiarmid
Address 12523 0
Building 2, 25 Sirius Rd
Lane Cove NSW 2066
Country 12523 0
Australia
Phone 12523 0
+61 2 9420 5833
Fax 12523 0
Email 12523 0
jmacdiarmid@engeneic.com
Contact person for scientific queries
Name 3451 0
Dr Jennifer MacDiarmid
Address 3451 0
Building 2, 25 Sirius Rd
Lane Cove NSW 2066
Country 3451 0
Australia
Phone 3451 0
+ 61 2 9420 5833
Fax 3451 0
Email 3451 0
jmacdiarmid@engeneic.com

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary