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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT02687386
Registration number
NCT02687386
Ethics application status
Date submitted
28/01/2016
Date registered
22/02/2016
Date last updated
14/02/2022
Titles & IDs
Public title
A Study of Intravenous EEDVsMit in Children With Recurrent / Refractory Solid or CNS Tumours Expressing EGFR
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Scientific title
A Phase 1 Study of Intravenous EGFR-ErbituxEDVsMIT (EEDVsMit) in Children With Recurrent / Refractory Solid or CNS Tumours Expressing Epidermal Growth Factor Receptor (EGFR) (ECREST Study)
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Secondary ID [1]
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KCA001
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Universal Trial Number (UTN)
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Trial acronym
ECREST
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Solid Tumours
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CNS Tumours
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Condition category
Condition code
Cancer
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Brain
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Cancer
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Children's - Brain
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Mitoxantrone packaged EDV (EnGeneIC Delivery Vehicle)
Experimental: Mitoxantrone packaged EDV - Mitoxantrone packaged EDV (EnGeneIC Dream Vector)
Treatment: Drugs: Mitoxantrone packaged EDV (EnGeneIC Delivery Vehicle)
EnGeneIC Delivery Vehicles (EDVs) are nanocells which can be loaded with anti-cancer drugs (mitoxantrone in this study) and targeted to tumor cells. These bacterially-derived nanocells are coated in bispecific antibodies (BsAb) that recognize oncogenic receptors on the tumor cell surface. Once bound to the tumour cell, the targeted and drug-loaded EDVs are endocytosed and release their toxic payload to destroy the tumor cell.
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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MTD at which fewer than one third of patients experience dose limiting toxicity as assessed by CTCAE v4.0
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Assessment method [1]
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To determine a recommended phase 2 dose (RP2D) for EEDVsMit administered intravenously in children with recurrent / refractory solid or CNS tumours expressing EGFR
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Timepoint [1]
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Day 28 (cycle 1)
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Primary outcome [2]
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Incidence of treatment-related adverse events as assessed by CTCAE v4.0
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Assessment method [2]
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To define and describe the toxicities of EEDVSMit administered on these schedules in children with recurrent/refractory solid or CNS tumours
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Timepoint [2]
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Up to 35 days after the completion of study treatment
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Primary outcome [3]
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Incidence of all adverse events as assessed by CTCAE v4.0, clinically significant changes in vital signs, ECGs and clinical laboratory tests
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Assessment method [3]
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Assess the safety and tolerability of EEDVSMit in children with recurrent/refractory solid or CNS tumours.
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Timepoint [3]
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Up to 35 days after the completion of study treatment
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Secondary outcome [1]
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Assess disease response according to RECIST version 1.1 for children with recurrent/refractory solid or CNS tumours
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Assessment method [1]
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To preliminarily define the anti-tumour activity of EEDVSMit and assess response rates using RECIST version 1.1 criteria in children with recurrent/refractory solid or CNS tumours within the confines of a phase 1 study.
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Timepoint [1]
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Up to 35 days after the completion of study treatment
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Secondary outcome [2]
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Assess overall survival
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Assessment method [2]
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Assess overall survival (OS) in children with recurrent/refractory solid or CNS tumours treated with EEDVSMit on this schedule
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Timepoint [2]
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12 months from the date the last subject was enrolled in the study.
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Secondary outcome [3]
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Time to response assessed by radiological imaging and RECIST v1.1
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Assessment method [3]
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Estimate the time to response.
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Timepoint [3]
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Evaluated at Day 56 (after cycle 2), then every second cycle to the end of study treatment (up to 12 months)
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Eligibility
Key inclusion criteria
- Patients must be = 2 years and = 21 years old at the time of study enrolment.
- Karnofsky = 50% for patients > 16 years of age and Lansky = 50 for patients = 16 years
of age
- Patients must have relapsed or refractory solid or CNS tumours or have a diagnosis of
DIPG. Patients must have had histologic verification of malignancy at original
diagnosis or relapse, or a diagnosis of DIPG by MRI imaging.
- Patients must have either measurable or evaluable disease for Part B of the study only
- Patient's current disease state must be one for which there is no known curative
therapy or therapy proven to prolong survival with an acceptable quality of life.
- Patients must have fully recovered from the acute toxic effects of all prior
chemotherapy, immunotherapy, or radiotherapy prior to entering this study
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Minimum age
2
Years
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Maximum age
21
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- Pregnant or breast-feeding women will not be entered on this study.
- Any active uncontrolled infection
- Patients who are known to be serologically positive for Hepatitis A, B or C, or have a
history of liver disease, other forms of hepatitis or cirrhosis.
- Known positive test for human immunodeficiency virus infection
- Patients with disease of any major organ system that would compromise their ability to
withstand therapy
- Concurrent or prior (within 7 days of enrolment) anticoagulation therapy, except low
molecular weight heparins or low dose aspirin
- Patients receiving corticosteroids must be on a stable dose that has not been
increased for at least 7 days prior to study enrolment.
- Patients who are currently receiving another investigational drug are ineligible.
- Patients who are currently receiving other antineoplastic agents are ineligible.
- All herbal supplements, vitamins, and nutritional supplements taken within the last 30
days prior to dosing on Day 1 (and continued use, if appropriate), must be reviewed
and approved by the Study Chair.
- Patient will not be available for protocol-required study visits or procedures, to the
best of the subject/parent/guardian's and investigator's knowledge.
- Patient has any kind of disorder that, in the opinion of the investigator, may
compromise the ability of the subject/parent/guardian to give written informed consent
and/or to comply with all required study procedures.
- History or evidence of any other clinically significant disorder, condition or disease
(with the exception of those outlined above) that, in the opinion of the investigator
would pose a risk to subject safety or interfere with the study evaluation, procedures
or completion.
- Patients will be screened for antibodies to S. typhimurium and will not be eligible
until antibodies are non-detectable
- Patients will be screened for IL6 and TNFa cytokines and will not be eligible until
levels are less than 3x times the detectable limit of the assay.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
N/A
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Phase 1
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Terminated
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
8/02/2016
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
29/12/2021
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Sample size
Target
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Accrual to date
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Final
9
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Recruitment in Australia
Recruitment state(s)
NSW
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Recruitment hospital [1]
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Sydney Children's Hospital - Randwick
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Recruitment hospital [2]
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The Children's Hospital at Westmead - Westmead
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Recruitment postcode(s) [1]
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2031 - Randwick
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Recruitment postcode(s) [2]
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- Westmead
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Funding & Sponsors
Primary sponsor type
Other
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Name
Dr David Ziegler
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Address
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Country
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Other collaborator category [1]
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Commercial sector/Industry
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Name [1]
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Engeneic Pty Limited
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Address [1]
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Country [1]
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Ethics approval
Ethics application status
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Summary
Brief summary
This is an open-label, sequential dose exploration study of single agent EEDVSMit
administered by intravenous (IV) infusion twice weekly, followed by weekly maintenance
dosing, in children with recurrent/refractory solid or CNS tumours.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT02687386
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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David Ziegler, MBBS
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Address
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Sydney Children's Hospitals Network
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT02687386
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