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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 September 14, 2014