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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/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/study/NCT01472003
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Trial related presentations / publications
Gan HK, Burge M, Solomon B, Lee ST, Holen KD, Zhang Y, Ciprotti M, Lee FT, Munasinghe W, Fischer J, Ansell P, Fox G, Xiong H, Reilly EB, Humerickhouse R, Scott AM. A Phase 1 and Biodistribution Study of ABT-806i, an 111In-Radiolabeled Conjugate of the Tumor-Specific Anti-EGFR Antibody ABT-806. J Nucl Med. 2021 Jun 1;62(6):787-794. doi: 10.2967/jnumed.120.253146. Epub 2021 Jan 28.
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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
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT01472003
Download to PDF