Phase 2 Study of AZD6244 Hydrogen Sulfate in Iodine-131 Refractory Papillary Thyroid Carcinoma and Papillary Thyroid Carcinoma With Follicular Elements
I. Ascertain the objective response rate (complete response and partial response) in
patients with iodine I 131-refractory papillary thyroid cancer treated with AZD6244.
I. Determine the toxicity of this treatment in these patients. II. Determine the
pharmacokinetic profile of this treatment in these patients. III. Determine the
progression-free and overall survival of these patients. IV. Assess proxy measures of
treatment response (thyroglobulin and PET scan) in patients treated with AZD6244.
IV. Compare relevant laboratory correlates between responders and non-responders.
OUTLINE: This is a multicenter study.
Patients receive oral AZD6244 twice daily on days 1-28. Treatment repeats every 28 days in
the absence of unacceptable toxicity or disease progression.
Archived tissue is examined for gene mutations, including RET, BRAF, NTRK, and RAS, by
fluorescence in situ hybridization and/or polymerase chain reaction and fluorescence melting
curve analysis. Protein expression of ERK and phosphorylated ERK is assessed by
Blood samples are collected periodically for pharmacokinetic analysis and biomarker
assessment (thyroglobulin and antithyroglobulin autoantibodies).
After completion of study therapy, patients are followed periodically for up to 2 years.
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Objective response rate (complete response and partial response)
Up to 2 years
H. Lee Moffitt Cancer Center and Research Institute
United States: Food and Drug Administration
|H. Lee Moffitt Cancer Center and Research Institute||Tampa, Florida 33612|
|Fox Chase Cancer Center||Philadelphia, Pennsylvania 19111|
|Vanderbilt University||Nashville, Tennessee 37232-6305|
|University of Chicago||Chicago, Illinois 60637|