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
  Purpose

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.


Condition Intervention Phase
Advanced Solid Tumors
Drug: ABT-806
Drug: ABT-806i
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official 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)

Resource links provided by NLM:


Further study details as provided by AbbVie:

Primary Outcome Measures:
  • 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)


Secondary Outcome Measures:
  • 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.


Enrollment: 18
Study Start Date: October 2011
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ABT-806 Arm
Subjects with advanced solid tumors
Drug: ABT-806
ABT-806 will be administered by intravenous infusion.
Experimental: ABT-806i Arm
Subjects with advanced solid tumors
Drug: ABT-806i
ABT-806i will be administered by intravenous infusion.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01472003

Locations
Australia
Site Reference ID/Investigator# 52203
Heidelberg, Australia, 3084
Site Reference ID/Investigator# 58242
Herston, Australia, 4029
Sponsors and Collaborators
AbbVie (prior sponsor, Abbott)
Investigators
Study Director: Kyle D. Holen, MD AbbVie
  More Information

No publications provided

Responsible Party: AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier: NCT01472003     History of Changes
Other Study ID Numbers: M11-849
Study First Received: October 12, 2011
Last Updated: January 10, 2013
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration
United States: Food and Drug Administration

Additional relevant MeSH terms:
Neoplasms

ClinicalTrials.gov processed this record on April 17, 2014