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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
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)
Secondary ID [1] 0 0
M11-849
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Advanced Solid Tumors 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Single-Photon Emission Computerized Tomography (SPECT)
Timepoint [1] 0 0
Week 1
Primary outcome [2] 0 0
Single-Photon Emission Computerized Tomography (SPECT)
Timepoint [2] 0 0
Week 6
Primary outcome [3] 0 0
Whole body planar imaging
Timepoint [3] 0 0
Week 1
Primary outcome [4] 0 0
Whole body planar imaging
Timepoint [4] 0 0
Week 6
Secondary outcome [1] 0 0
Pharmacokinetic profile evaluation - Cohort 1
Timepoint [1] 0 0
From Day 1 through Final Visit
Secondary outcome [2] 0 0
Pharmacokinetic profile evaluation - Cohort 2
Timepoint [2] 0 0
From Day 1 through Final Visit
Secondary outcome [3] 0 0
Single-Photon Emission Computerized Tomography (SPECT)
Timepoint [3] 0 0
Week 1
Secondary outcome [4] 0 0
Single-Photon Emission Computerized Tomography (SPECT)
Timepoint [4] 0 0
Week 6
Secondary outcome [5] 0 0
Whole body planar imaging
Timepoint [5] 0 0
Week 1
Secondary outcome [6] 0 0
Whole body planar imaging
Timepoint [6] 0 0
Week 6
Secondary outcome [7] 0 0
Blood pressure - Cohort 1
Timepoint [7] 0 0
Screening through Week 2
Secondary outcome [8] 0 0
Heart rate - Cohort 1
Timepoint [8] 0 0
Screening through Week 2
Secondary outcome [9] 0 0
Body temperature - Cohort 1
Timepoint [9] 0 0
Screening through Week 2
Secondary outcome [10] 0 0
Number of subjects with Adverse Events - Cohort 1
Timepoint [10] 0 0
Day 1 Through Week 2
Secondary outcome [11] 0 0
Chemistry - Cohort 1
Timepoint [11] 0 0
Sceening, Week 1 and Final Visit
Secondary outcome [12] 0 0
Hematology - Cohort 1
Timepoint [12] 0 0
Sceening, Week 1 and Final Visit
Secondary outcome [13] 0 0
Urinalysis - Cohort 1
Timepoint [13] 0 0
Sceening, Week 1 and Final Visit
Secondary outcome [14] 0 0
Physical Examination - Cohort 1
Timepoint [14] 0 0
Screening, Week 1 and Final Visit
Secondary outcome [15] 0 0
Electrocardiogram (ECG) - Cohort 1
Timepoint [15] 0 0
Baseline and Final Visit
Secondary outcome [16] 0 0
Heart rate - Cohort 2
Timepoint [16] 0 0
Screening Through Week 8
Secondary outcome [17] 0 0
Blood pressure - Cohort 2
Timepoint [17] 0 0
Screening Through Week 8
Secondary outcome [18] 0 0
Number of subjects with Adverse Events - Cohort 2
Timepoint [18] 0 0
Day 1 Through Week 8
Secondary outcome [19] 0 0
Body temperature - Cohort 2
Timepoint [19] 0 0
Screening Through Week 8
Secondary outcome [20] 0 0
Hematology - Cohort 2
Timepoint [20] 0 0
Screening, Week 1, 2, 4, 6, and Final Visit
Secondary outcome [21] 0 0
Chemistry - Cohort 2
Timepoint [21] 0 0
Screening, Week 1, 2, 4, 6, and Final Visit
Secondary outcome [22] 0 0
Physical Examination - Cohort 2
Timepoint [22] 0 0
Screening, Week 1, 2, 4, 6, and Final Visit
Secondary outcome [23] 0 0
Urinalysis - Cohort 2
Timepoint [23] 0 0
Screening, Week 1, 2, 4, 6, and Final Visit
Secondary outcome [24] 0 0
Electrocardiogram (ECG) - Cohort 2
Timepoint [24] 0 0
Baseline and Week 6

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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Diagnosis
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
Single group
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/10/2011
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/12/2012
Sample size
Target
Accrual to date
Final
18
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Site Reference ID/Investigator# 52203 - Heidelberg
Recruitment hospital [2] 0 0
Site Reference ID/Investigator# 58242 - Herston
Recruitment postcode(s) [1] 0 0
3084 - Heidelberg
Recruitment postcode(s) [2] 0 0
4029 - Herston

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
AbbVie (prior sponsor, Abbott)
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Kyle D. Holen, MD
Address 0 0
AbbVie
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
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