Status:
COMPLETED
A Study of ABT-806 in Subjects With Advanced Solid Tumor Types
Lead Sponsor:
AbbVie (prior sponsor, Abbott)
Conditions:
Advanced Solid Tumors
Eligibility:
All Genders
18-99 years
Phase:
PHASE1
Brief Summary
This is an open-label study designed to determine the recommended Phase 2 dose (RPTD) and evaluate the safety and pharmacokinetics of ABT-806 in subjects with advanced solid tumors.
Eligibility Criteria
Inclusion
- Subject has a solid tumor of a type known to either over-express wild-type EGFR or to express variant III mutant EGFR (e.g., head and neck squamous cell carcinoma, non small cell lung cancer (NSCLC), colorectal carcinoma) or a tumor known to be EGFR positive.
- Subject must have disease that is not amenable to surgical resection or other approved therapeutic options with curative intent.
- Subject has an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2.
- Subject must have measurable disease per Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1.
- Inclusion criteria for Expand Safety Cohort B - subject has histologically confirmed supratentorial glioblastoma multiforme (GBM) .
Exclusion
- Subject has uncontrolled metastases to the central nervous system. Subjects with brain metastases are eligible provided they have shown clinical and radiographic stable disease for at least 1 month after definitive therapy. Subjects with glioblastoma multiforme (GBM) are excluded from the dose escalation portion of the study, but may be enrolled in the expanded safety cohort.
- Subject has received anticancer therapy including chemotherapy, immunotherapy, radiotherapy, hormonal, biologic, or any investigational therapy within a period of 21 days prior to the first dose of ABT-806.
- Subject has had any adjustments of an ongoing steroid medication during the 14 days prior to the first dose of ABT-806.
- Subject has received a prior EGFR-directed monoclonal antibody within a period of 4 weeks prior to the first dose of ABT-806.
- Subject has unresolved clinically significant toxicities from prior anticancer therapy, defined as any Common Terminology Criteria for Adverse Events (CTCAE) Grade 2 or higher.
Key Trial Info
Start Date :
November 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2012
Estimated Enrollment :
49 Patients enrolled
Trial Details
Trial ID
NCT01255657
Start Date
November 1 2010
End Date
November 1 2012
Last Update
November 21 2017
Active Locations (3)
Enter a location and click search to find clinical trials sorted by distance.
1
Site Reference ID/Investigator# 54056
Baltimore, Maryland, United States, 21231
2
Site Reference ID/Investigator# 41931
Boston, Massachusetts, United States, 02215
3
Site Reference ID/Investigator# 43422
Tacoma, Washington, United States, 98405