A Phase 1 Study of ABT-806 in Subjects With Advanced Solid Tumor Types Likely to Either Overexpress Wild-Type Epidermal Growth Factor Receptor (EGFR) or to Express Variant III Mutant EGFR
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Safety (Number of subjects with adverse events and/or dose-limiting toxicities)
Evaluation of vital signs, clinical lab testing and adverse event monitoring (every other week), physical exam (every 4 weeks) and ECG (periodic)
At each treatment visit (weekly for first 4 weeks and then at least every 4 weeks through end of treatment)
Yes
Kyle D. Holen, MD
Study Director
AbbVie
United States: Food and Drug Administration
M11-847
NCT01255657
November 2010
November 2012
Name | Location |
---|---|
Site Reference ID/Investigator# 54056 | Baltimore, Maryland 21231 |
Site Reference ID/Investigator# 41931 | Boston, Massachusetts 02115 |
Site Reference ID/Investigator# 43422 | Tacoma, Washington 98405 |