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

January 10, 2013 updated by: AbbVie (prior sponsor, Abbott)

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
18

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
      • Heidelberg, Australia, 3084
        • Site Reference ID/Investigator# 52203
      • Herston, Australia, 4029
        • Site Reference ID/Investigator# 58242

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Single-Photon Emission Computerized Tomography (SPECT)
Time Frame: Week 1
Tumor receptor occupancy (Cohort 1 and Cohort 2)
Week 1
Single-Photon Emission Computerized Tomography (SPECT)
Time Frame: Week 6
Tumor receptor occupancy (Cohort 2)
Week 6
Whole body planar imaging
Time Frame: Week 1
Biodistribution and dosimetry (Cohort 1 and Cohort 2)
Week 1
Whole body planar imaging
Time Frame: Week 6
Biodistribution and dosimetry (Cohort 2)
Week 6

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Pharmacokinetic profile evaluation - Cohort 1
Time Frame: From Day 1 through Final Visit
Blood samples for ABT-806/ABT-806i will be collected and assayed at designated timepoints
From Day 1 through Final Visit
Pharmacokinetic profile evaluation - Cohort 2
Time Frame: From Day 1 through Final Visit
Blood samples for ABT-806/ABT-806i will be collected and assayed at designated timepoints
From Day 1 through Final Visit
Single-Photon Emission Computerized Tomography (SPECT)
Time Frame: Week 1
ABT-806i uptake correlation with Epidermal Growth Factor Receptor (EGFR) vIII expression - Cohort 2
Week 1
Single-Photon Emission Computerized Tomography (SPECT)
Time Frame: Week 6
ABT-806i uptake correlation with EGFR vIII expression - Cohort 2
Week 6
Whole body planar imaging
Time Frame: Week 1
ABT-806i uptake correlation with Epidermal Growth Factor Receptor (EGFR) vIII expression - Cohort 2
Week 1
Whole body planar imaging
Time Frame: Week 6
ABT-806i uptake correlation with EGFR vIII expression - Cohort 2
Week 6
Blood pressure - Cohort 1
Time Frame: Screening through Week 2
Screening through Week 2
Heart rate - Cohort 1
Time Frame: Screening through Week 2
Screening through Week 2
Body temperature - Cohort 1
Time Frame: Screening through Week 2
Screening through Week 2
Number of subjects with Adverse Events - Cohort 1
Time Frame: Day 1 Through Week 2
The investigator will monitor each subject for clinical and laboratory evidence of adverse events.
Day 1 Through Week 2
Chemistry - Cohort 1
Time Frame: Sceening, Week 1 and Final Visit
Sceening, Week 1 and Final Visit
Hematology - Cohort 1
Time Frame: Sceening, Week 1 and Final Visit
Sceening, Week 1 and Final Visit
Urinalysis - Cohort 1
Time Frame: Sceening, Week 1 and Final Visit
Sceening, Week 1 and Final Visit
Physical Examination - Cohort 1
Time Frame: Screening, Week 1 and Final Visit
Physical exam including body weight will be performed.
Screening, Week 1 and Final Visit
Electrocardiogram (ECG) - Cohort 1
Time Frame: Baseline and Final Visit
12-lead ECG will be performed.
Baseline and Final Visit
Heart rate - Cohort 2
Time Frame: Screening Through Week 8
Screening Through Week 8
Blood pressure - Cohort 2
Time Frame: Screening Through Week 8
Screening Through Week 8
Number of subjects with Adverse Events - Cohort 2
Time Frame: Day 1 Through Week 8
The investigator will monitor each subject for clinical and laboratory evidence of adverse events.
Day 1 Through Week 8
Body temperature - Cohort 2
Time Frame: Screening Through Week 8
Screening Through Week 8
Hematology - Cohort 2
Time Frame: Screening, Week 1, 2, 4, 6, and Final Visit
Screening, Week 1, 2, 4, 6, and Final Visit
Chemistry - Cohort 2
Time Frame: Screening, Week 1, 2, 4, 6, and Final Visit
Screening, Week 1, 2, 4, 6, and Final Visit
Physical Examination - Cohort 2
Time Frame: Screening, Week 1, 2, 4, 6, and Final Visit
Physical exam including body weight will be performed.
Screening, Week 1, 2, 4, 6, and Final Visit
Urinalysis - Cohort 2
Time Frame: Screening, Week 1, 2, 4, 6, and Final Visit
Screening, Week 1, 2, 4, 6, and Final Visit
Electrocardiogram (ECG) - Cohort 2
Time Frame: Baseline and Week 6
12-lead ECG will be performed.
Baseline and Week 6

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
AbbVie (prior sponsor, Abbott)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Kyle D. Holen, MD, AbbVie

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2011

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2012

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2012

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 12, 2011

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 11, 2011

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 16, 2011

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 14, 2013

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 10, 2013

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • M11-849

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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