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

Advanced Solid Tumors Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01472003
• Other study ID #: M11-849
• Status: Completed
• Phase: Phase 1
• First received: October 12, 2011
• Last updated: January 10, 2013
• Start date: October 2011
• Est. completion date: December 2012

Study information

• Verified date: January 2013
• Source: AbbVie
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Department of Health and Ageing Therapeutic Goods AdministrationUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Advanced Solid Tumors

Intervention

Drug:
• ABT-806
ABT-806 will be administered by intravenous infusion.
• ABT-806i
ABT-806i will be administered by intravenous infusion.

Locations

Country	Name	City	State
Australia	Site Reference ID/Investigator# 52203	Heidelberg
Australia	Site Reference ID/Investigator# 58242	Herston

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie (prior sponsor, Abbott)

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Single-Photon Emission Computerized Tomography (SPECT)	Tumor receptor occupancy (Cohort 1 and Cohort 2)	Week 1	No
Primary	Single-Photon Emission Computerized Tomography (SPECT)	Tumor receptor occupancy (Cohort 2)	Week 6	No
Primary	Whole body planar imaging	Biodistribution and dosimetry (Cohort 1 and Cohort 2)	Week 1	No
Primary	Whole body planar imaging	Biodistribution and dosimetry (Cohort 2)	Week 6	No
Secondary	Pharmacokinetic profile evaluation - Cohort 1	Blood samples for ABT-806/ABT-806i will be collected and assayed at designated timepoints	From Day 1 through Final Visit	Yes
Secondary	Pharmacokinetic profile evaluation - Cohort 2	Blood samples for ABT-806/ABT-806i will be collected and assayed at designated timepoints	From Day 1 through Final Visit	Yes
Secondary	Single-Photon Emission Computerized Tomography (SPECT)	ABT-806i uptake correlation with Epidermal Growth Factor Receptor (EGFR) vIII expression - Cohort 2	Week 1	No
Secondary	Single-Photon Emission Computerized Tomography (SPECT)	ABT-806i uptake correlation with EGFR vIII expression - Cohort 2	Week 6	No
Secondary	Whole body planar imaging	ABT-806i uptake correlation with Epidermal Growth Factor Receptor (EGFR) vIII expression - Cohort 2	Week 1	No
Secondary	Whole body planar imaging	ABT-806i uptake correlation with EGFR vIII expression - Cohort 2	Week 6	No
Secondary	Blood pressure - Cohort 1		Screening through Week 2	Yes
Secondary	Heart rate - Cohort 1		Screening through Week 2	Yes
Secondary	Body temperature - Cohort 1		Screening through Week 2	Yes
Secondary	Number of subjects with Adverse Events - Cohort 1	The investigator will monitor each subject for clinical and laboratory evidence of adverse events.	Day 1 Through Week 2	Yes
Secondary	Chemistry - Cohort 1		Sceening, Week 1 and Final Visit	Yes
Secondary	Hematology - Cohort 1		Sceening, Week 1 and Final Visit	Yes
Secondary	Urinalysis - Cohort 1		Sceening, Week 1 and Final Visit	Yes
Secondary	Physical Examination - Cohort 1	Physical exam including body weight will be performed.	Screening, Week 1 and Final Visit	Yes
Secondary	Electrocardiogram (ECG) - Cohort 1	12-lead ECG will be performed.	Baseline and Final Visit	Yes
Secondary	Heart rate - Cohort 2		Screening Through Week 8	Yes
Secondary	Blood pressure - Cohort 2		Screening Through Week 8	Yes
Secondary	Number of subjects with Adverse Events - Cohort 2	The investigator will monitor each subject for clinical and laboratory evidence of adverse events.	Day 1 Through Week 8	Yes
Secondary	Body temperature - Cohort 2		Screening Through Week 8	Yes
Secondary	Hematology - Cohort 2		Screening, Week 1, 2, 4, 6, and Final Visit	Yes
Secondary	Chemistry - Cohort 2		Screening, Week 1, 2, 4, 6, and Final Visit	Yes
Secondary	Physical Examination - Cohort 2	Physical exam including body weight will be performed.	Screening, Week 1, 2, 4, 6, and Final Visit	Yes
Secondary	Urinalysis - Cohort 2		Screening, Week 1, 2, 4, 6, and Final Visit	Yes
Secondary	Electrocardiogram (ECG) - Cohort 2	12-lead ECG will be performed.	Baseline and Week 6	Yes