Status:
COMPLETED
An Evaluation of the Biodistribution and Imaging Characteristics of ABT-806i (111In-ABT-806) in Subjects With Advanced Solid Tumor Types
Lead Sponsor:
AbbVie (prior sponsor, Abbott)
Conditions:
Advanced Solid Tumors
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief 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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2012
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT01472003
Start Date
October 1 2011
End Date
December 1 2012
Last Update
January 14 2013
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Site Reference ID/Investigator# 52203
Heidelberg, Australia, 3084
2
Site Reference ID/Investigator# 58242
Herston, Australia, 4029