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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/NCT01472003
Registration number
NCT01472003
Ethics application status
Date submitted
12/10/2011
Date registered
16/11/2011
Date last updated
14/01/2013
Titles & IDs
Public title
An Evaluation of the Biodistribution and Imaging Characteristics of ABT-806i (111In-ABT-806) in Subjects With Advanced Solid Tumor Types
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Scientific title
An Evaluation of the Biodistribution and Imaging Characteristics of ABT-806i (111In-ABT-806) in Subjects With Advanced Solid Tumor Types Likely to Express Epidermal Growth Factor Receptor (EGFR)
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Secondary ID [1]
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M11-849
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Advanced Solid Tumors
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Condition category
Condition code
Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - ABT-806
Treatment: Drugs - ABT-806i
Experimental: ABT-806 Arm - Subjects with advanced solid tumors
Experimental: ABT-806i Arm - Subjects with advanced solid tumors
Treatment: Drugs: ABT-806
ABT-806 will be administered by intravenous infusion.
Treatment: Drugs: ABT-806i
ABT-806i will be administered by intravenous infusion.
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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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Single-Photon Emission Computerized Tomography (SPECT)
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Assessment method [1]
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Tumor receptor occupancy (Cohort 1 and Cohort 2)
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Timepoint [1]
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Week 1
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Primary outcome [2]
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Single-Photon Emission Computerized Tomography (SPECT)
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Assessment method [2]
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Tumor receptor occupancy (Cohort 2)
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Timepoint [2]
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Week 6
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Primary outcome [3]
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Whole body planar imaging
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Assessment method [3]
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Biodistribution and dosimetry (Cohort 1 and Cohort 2)
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Timepoint [3]
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Week 1
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Primary outcome [4]
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Whole body planar imaging
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Assessment method [4]
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Biodistribution and dosimetry (Cohort 2)
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Timepoint [4]
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Week 6
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Secondary outcome [1]
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Pharmacokinetic profile evaluation - Cohort 1
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Assessment method [1]
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Blood samples for ABT-806/ABT-806i will be collected and assayed at designated timepoints
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Timepoint [1]
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From Day 1 through Final Visit
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Secondary outcome [2]
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Pharmacokinetic profile evaluation - Cohort 2
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Assessment method [2]
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Blood samples for ABT-806/ABT-806i will be collected and assayed at designated timepoints
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Timepoint [2]
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From Day 1 through Final Visit
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Secondary outcome [3]
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Single-Photon Emission Computerized Tomography (SPECT)
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Assessment method [3]
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ABT-806i uptake correlation with Epidermal Growth Factor Receptor (EGFR) vIII expression - Cohort 2
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Timepoint [3]
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Week 1
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Secondary outcome [4]
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Single-Photon Emission Computerized Tomography (SPECT)
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Assessment method [4]
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ABT-806i uptake correlation with EGFR vIII expression - Cohort 2
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Timepoint [4]
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Week 6
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Secondary outcome [5]
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Whole body planar imaging
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Assessment method [5]
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ABT-806i uptake correlation with Epidermal Growth Factor Receptor (EGFR) vIII expression - Cohort 2
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Timepoint [5]
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Week 1
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Secondary outcome [6]
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Whole body planar imaging
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Assessment method [6]
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ABT-806i uptake correlation with EGFR vIII expression - Cohort 2
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Timepoint [6]
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Week 6
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Secondary outcome [7]
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Blood pressure - Cohort 1
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Assessment method [7]
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Timepoint [7]
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Screening through Week 2
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Secondary outcome [8]
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Heart rate - Cohort 1
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Assessment method [8]
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Timepoint [8]
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Screening through Week 2
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Secondary outcome [9]
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Body temperature - Cohort 1
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Assessment method [9]
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Timepoint [9]
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Screening through Week 2
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Secondary outcome [10]
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Number of subjects with Adverse Events - Cohort 1
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Assessment method [10]
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The investigator will monitor each subject for clinical and laboratory evidence of adverse events.
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Timepoint [10]
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Day 1 Through Week 2
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Secondary outcome [11]
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Chemistry - Cohort 1
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Assessment method [11]
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Timepoint [11]
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Sceening, Week 1 and Final Visit
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Secondary outcome [12]
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Hematology - Cohort 1
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Assessment method [12]
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Timepoint [12]
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Sceening, Week 1 and Final Visit
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Secondary outcome [13]
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Urinalysis - Cohort 1
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Assessment method [13]
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Timepoint [13]
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Sceening, Week 1 and Final Visit
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Secondary outcome [14]
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Physical Examination - Cohort 1
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Assessment method [14]
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Physical exam including body weight will be performed.
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Timepoint [14]
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Screening, Week 1 and Final Visit
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Secondary outcome [15]
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Electrocardiogram (ECG) - Cohort 1
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Assessment method [15]
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12-lead ECG will be performed.
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Timepoint [15]
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Baseline and Final Visit
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Secondary outcome [16]
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Heart rate - Cohort 2
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Assessment method [16]
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Timepoint [16]
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Screening Through Week 8
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Secondary outcome [17]
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Blood pressure - Cohort 2
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Assessment method [17]
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Timepoint [17]
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Screening Through Week 8
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Secondary outcome [18]
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Number of subjects with Adverse Events - Cohort 2
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Assessment method [18]
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The investigator will monitor each subject for clinical and laboratory evidence of adverse events.
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Timepoint [18]
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Day 1 Through Week 8
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Secondary outcome [19]
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Body temperature - Cohort 2
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Assessment method [19]
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Timepoint [19]
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Screening Through Week 8
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Secondary outcome [20]
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Hematology - Cohort 2
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Assessment method [20]
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Timepoint [20]
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Screening, Week 1, 2, 4, 6, and Final Visit
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Secondary outcome [21]
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Chemistry - Cohort 2
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Assessment method [21]
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Timepoint [21]
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Screening, Week 1, 2, 4, 6, and Final Visit
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Secondary outcome [22]
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Physical Examination - Cohort 2
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Assessment method [22]
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Physical exam including body weight will be performed.
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Timepoint [22]
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Screening, Week 1, 2, 4, 6, and Final Visit
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Secondary outcome [23]
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Urinalysis - Cohort 2
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Assessment method [23]
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Timepoint [23]
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Screening, Week 1, 2, 4, 6, and Final Visit
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Secondary outcome [24]
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Electrocardiogram (ECG) - Cohort 2
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Assessment method [24]
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12-lead ECG will be performed.
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Timepoint [24]
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Baseline and Week 6
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Eligibility
Key inclusion criteria
- Subject has a solid tumor of a type likely or known to either overexpress wild-type
Epidermal Growth Factor Receptor (EGFR) or to express variant III mutant EGFR (e.g.,
head and neck squamous cell carcinoma, Non-small Cell Lung Carcinoma (NSCLC), and
colorectal carcinoma).
- Subject must have disease that is not amenable to surgical resection or other approved
therapeutic options with curative intent.
- Subject cannot tolerate or must not be eligible for other approved therapeutic options
with known survival advantage.
- Subject has an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2.
- Subject must have measurable disease as defined by Response Evaluation Criteria in
Solid Tumors (RECIST) version 1.1 with at least 1 extrahepatic 2 cm lesion.
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Minimum age
18
Years
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Maximum age
No limit
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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
- Subject has received anticancer therapy including chemotherapy, immunotherapy,
radiotherapy, hormonal, biologic, or any investigational therapy within a period of 14
days prior to the first dose of ABT-806i.
- Subject has received a prior EGFR-directed monoclonal antibody within a period of 4
weeks prior to the first dose of ABT-806i.
- Subject has unresolved clinically significant toxicities from prior anticancer
therapy, defined as any Common Terminology Criteria for Adverse Events (CTCAE) Grade 2
or higher.
- Subject has had major surgery within 21 days prior to the first dose of ABT-806i.
- Subject has a clinically significant uncontrolled condition(s) including but not
limited to the following:
- Active uncontrolled infection
- Symptomatic congestive heart failure
- Unstable angina pectoris or cardiac arrhythmia
- Psychiatric illness/social situation that would limit compliance with the study
requirements
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Study design
Purpose of the study
Diagnosis
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Allocation to intervention
Non-randomised trial
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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
Completed
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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
1/10/2011
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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
1/12/2012
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Sample size
Target
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Accrual to date
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Final
18
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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Site Reference ID/Investigator# 52203 - Heidelberg
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Recruitment hospital [2]
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Site Reference ID/Investigator# 58242 - Herston
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Recruitment postcode(s) [1]
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3084 - Heidelberg
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Recruitment postcode(s) [2]
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4029 - Herston
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
AbbVie (prior sponsor, Abbott)
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
This is an open label study designed to evaluate the biodistribution and imaging
characteristics of ABT-806i (111In-ABT-806) in subjects with advanced solid tumor types.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT01472003
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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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Kyle D. Holen, MD
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Address
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AbbVie
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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/NCT01472003
Download to PDF