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An Evaluation of the Biodistribution and Imaging Characteristics of ABT-806i (111In-ABT-806) in Subjects With Advanced Solid Tumor Types

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier:
NCT01472003
First received: October 12, 2011
Last updated: January 10, 2013
Last verified: January 2013
History of Changes

October 12, 2011
January 10, 2013
October 2011
December 2012   (final data collection date for primary outcome measure)
  • Single-Photon Emission Computerized Tomography (SPECT) [ Time Frame: Week 1 ] [ Designated as safety issue: No ]
    Tumor receptor occupancy (Cohort 1 and Cohort 2)
  • Single-Photon Emission Computerized Tomography (SPECT) [ Time Frame: Week 6 ] [ Designated as safety issue: No ]
    Tumor receptor occupancy (Cohort 2)
  • Whole body planar imaging [ Time Frame: Week 1 ] [ Designated as safety issue: No ]
    Biodistribution and dosimetry (Cohort 1 and Cohort 2)
  • Whole body planar imaging [ Time Frame: Week 6 ] [ Designated as safety issue: No ]
    Biodistribution and dosimetry (Cohort 2)
Same as current
Complete list of historical versions of study NCT01472003 on ClinicalTrials.gov Archive Site
  • Pharmacokinetic profile evaluation - Cohort 1 [ Time Frame: From Day 1 through Final Visit ] [ Designated as safety issue: Yes ]
    Blood samples for ABT-806/ABT-806i will be collected and assayed at designated timepoints
  • Pharmacokinetic profile evaluation - Cohort 2 [ Time Frame: From Day 1 through Final Visit ] [ Designated as safety issue: Yes ]
    Blood samples for ABT-806/ABT-806i will be collected and assayed at designated timepoints
  • Single-Photon Emission Computerized Tomography (SPECT) [ Time Frame: Week 1 ] [ Designated as safety issue: No ]
    ABT-806i uptake correlation with Epidermal Growth Factor Receptor (EGFR) vIII expression - Cohort 2
  • Single-Photon Emission Computerized Tomography (SPECT) [ Time Frame: Week 6 ] [ Designated as safety issue: No ]
    ABT-806i uptake correlation with EGFR vIII expression - Cohort 2
  • Whole body planar imaging [ Time Frame: Week 1 ] [ Designated as safety issue: No ]
    ABT-806i uptake correlation with Epidermal Growth Factor Receptor (EGFR) vIII expression - Cohort 2
  • Whole body planar imaging [ Time Frame: Week 6 ] [ Designated as safety issue: No ]
    ABT-806i uptake correlation with EGFR vIII expression - Cohort 2
  • Blood pressure - Cohort 1 [ Time Frame: Screening through Week 2 ] [ Designated as safety issue: Yes ]
  • Heart rate - Cohort 1 [ Time Frame: Screening through Week 2 ] [ Designated as safety issue: Yes ]
  • Body temperature - Cohort 1 [ Time Frame: Screening through Week 2 ] [ Designated as safety issue: Yes ]
  • Number of subjects with Adverse Events - Cohort 1 [ Time Frame: Day 1 Through Week 2 ] [ Designated as safety issue: Yes ]
    The investigator will monitor each subject for clinical and laboratory evidence of adverse events.
  • Chemistry - Cohort 1 [ Time Frame: Sceening, Week 1 and Final Visit ] [ Designated as safety issue: Yes ]
  • Hematology - Cohort 1 [ Time Frame: Sceening, Week 1 and Final Visit ] [ Designated as safety issue: Yes ]
  • Urinalysis - Cohort 1 [ Time Frame: Sceening, Week 1 and Final Visit ] [ Designated as safety issue: Yes ]
  • Physical Examination - Cohort 1 [ Time Frame: Screening, Week 1 and Final Visit ] [ Designated as safety issue: Yes ]
    Physical exam including body weight will be performed.
  • Electrocardiogram (ECG) - Cohort 1 [ Time Frame: Baseline and Final Visit ] [ Designated as safety issue: Yes ]
    12-lead ECG will be performed.
  • Heart rate - Cohort 2 [ Time Frame: Screening Through Week 8 ] [ Designated as safety issue: Yes ]
  • Blood pressure - Cohort 2 [ Time Frame: Screening Through Week 8 ] [ Designated as safety issue: Yes ]
  • Number of subjects with Adverse Events - Cohort 2 [ Time Frame: Day 1 Through Week 8 ] [ Designated as safety issue: Yes ]
    The investigator will monitor each subject for clinical and laboratory evidence of adverse events.
  • Body temperature - Cohort 2 [ Time Frame: Screening Through Week 8 ] [ Designated as safety issue: Yes ]
  • Hematology - Cohort 2 [ Time Frame: Screening, Week 1, 2, 4, 6, and Final Visit ] [ Designated as safety issue: Yes ]
  • Chemistry - Cohort 2 [ Time Frame: Screening, Week 1, 2, 4, 6, and Final Visit ] [ Designated as safety issue: Yes ]
  • Physical Examination - Cohort 2 [ Time Frame: Screening, Week 1, 2, 4, 6, and Final Visit ] [ Designated as safety issue: Yes ]
    Physical exam including body weight will be performed.
  • Urinalysis - Cohort 2 [ Time Frame: Screening, Week 1, 2, 4, 6, and Final Visit ] [ Designated as safety issue: Yes ]
  • Electrocardiogram (ECG) - Cohort 2 [ Time Frame: Baseline and Week 6 ] [ Designated as safety issue: Yes ]
    12-lead ECG will be performed.
  • Pharmacokinetic profile evaluation - Cohort 1 [ Time Frame: From Day 1 through Final Visit ] [ Designated as safety issue: Yes ]
    Blood samples for ABT-806/ABT-806i will be collected and assayed at designated timepoints
  • Pharmacokinetic profile evaluation - Cohort 2 [ Time Frame: From Day 1 through Final Visit ] [ Designated as safety issue: Yes ]
    Blood samples for ABT-806/ABT-806i will be collected and assayed at designated timepoints
  • Single-Photon Emission Computerized Tomography (SPECT) [ Time Frame: Week 1 ] [ Designated as safety issue: No ]
    ABT-806i uptake correlation with Epidermal Growth Factor Receptor (EGFR) vIII expression - Cohort 2
  • Single-Photon Emission Computerized Tomography (SPECT) [ Time Frame: Week 6 ] [ Designated as safety issue: No ]
    ABT-806i uptake correlation with EGFR vIII expression - Cohort 2
  • Whole body planar imaging [ Time Frame: Week 1 ] [ Designated as safety issue: No ]
    ABT-806i uptake correlation with Epidermal Growth Factor Receptor (EGFR) vIII expression - Cohort 2
  • Whole body planar imaging [ Time Frame: Week 6 ] [ Designated as safety issue: No ]
    ABT-806i uptake correlation with EGFR vIII expression - Cohort 2
  • Blood pressure - Cohort 1 [ Time Frame: Screening through Week 2 ] [ Designated as safety issue: Yes ]
  • Heart rate - Cohort 1 [ Time Frame: Screening through Week 2 ] [ Designated as safety issue: Yes ]
  • Body temperature - Cohort 1 [ Time Frame: Screening through Week 2 ] [ Designated as safety issue: Yes ]
  • Number of subjects with Adverse Events - Cohort 1 [ Time Frame: Through Week 2 ] [ Designated as safety issue: Yes ]
    The investigator will monitor each subject for clinical and laboratory evidence of adverse events.
  • Chemistry - Cohort 2 [ Time Frame: Sceening, Week 1 and Final Visit ] [ Designated as safety issue: Yes ]
  • Hematology - Cohort 1 [ Time Frame: Sceening, Week 1 and Final Visit ] [ Designated as safety issue: Yes ]
  • Urinalysis - Cohort 1 [ Time Frame: Sceening, Week 1 and Final Visit ] [ Designated as safety issue: Yes ]
  • Physical Examination - Cohort 1 [ Time Frame: Screening, Week 1 and Final Visit ] [ Designated as safety issue: Yes ]
    Physical exam including body weight will be performed.
  • Electrocardiogram (ECG) - Cohort 1 [ Time Frame: Baseline and Final Visit ] [ Designated as safety issue: Yes ]
    12-lead ECG will be performed.
  • Blood pressure - Cohort 2 [ Time Frame: Screening Through Week 8 ] [ Designated as safety issue: Yes ]
  • Heart rate - Cohort 2 [ Time Frame: Screening Through Week 8 ] [ Designated as safety issue: Yes ]
  • Body temperature - Cohort 2 [ Time Frame: Screening Through Week 8 ] [ Designated as safety issue: Yes ]
  • Number of subjects with Adverse Events - Cohort 2 [ Time Frame: Through Week 8 ] [ Designated as safety issue: Yes ]
    The investigator will monitor each subject for clinical and laboratory evidence of adverse events.
  • Chemistry - Cohort 2 [ Time Frame: Screening, Week 1, 2, 4, 6, and Final Visit ] [ Designated as safety issue: Yes ]
  • Hematology - Cohort 2 [ Time Frame: Screening, Week 1, 2, 4, 6, and Final Visit ] [ Designated as safety issue: Yes ]
  • Urinalysis - Cohort 2 [ Time Frame: Screening, Week 1, 2, 4, 6, and Final Visit ] [ Designated as safety issue: Yes ]
  • Physical Examination - Cohort 2 [ Time Frame: Screening, Week 1, 2, 4, 6, and Final Visit ] [ Designated as safety issue: Yes ]
    Physical exam including body weight will be performed.
  • Electrocardiogram (ECG) - Cohort 2 [ Time Frame: Baseline, Day 1, and Week 6 ] [ Designated as safety issue: Yes ]
    12-lead ECG will be performed.
Not Provided
Not Provided
 
An Evaluation of the Biodistribution and Imaging Characteristics of ABT-806i (111In-ABT-806) in Subjects With Advanced Solid Tumor Types
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)

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.
Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Advanced Solid Tumors
  • Drug: ABT-806
    ABT-806 will be administered by intravenous infusion.
  • Drug: ABT-806i
    ABT-806i will be administered by intravenous infusion.
  • Experimental: ABT-806 Arm
    Subjects with advanced solid tumors
    Intervention: Drug: ABT-806
  • Experimental: ABT-806i Arm
    Subjects with advanced solid tumors
    Intervention: Drug: ABT-806i
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
18
December 2012
December 2012   (final data collection date for primary outcome measure)

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.

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Australia
 
NCT01472003
M11-849
No
AbbVie ( AbbVie (prior sponsor, Abbott) )
AbbVie (prior sponsor, Abbott)
Not Provided
Study Director: Kyle D. Holen, MD AbbVie
AbbVie
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP