A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 3 Trial of E7080 in 131I-Refractory Differentiated Thyroid Cancer
To compare the progression-free survival of subjects with 131 I-refractory differentiated thyroid cancer (DTC) and radiographic evidence of disease progression within the prior 12 months treated with E7080 versus Placebo.
-confirmed diagnosis of Differentiated Thyroid Cancer (subtypes Papillary or Follicular) -measurable disease -evidence of disease progression within 12 months on scans -good physical condition with good blood counts and organ function -adequately controlled blood pressure less than 150/90 mmHG -subjects must have 131 I-refractory/ resistant disease -0-1 prior VEGF targeted therapy is allowed -brain metastases are allowed as long as they have been treated and controlled for 1 month -subjects must be receiving thyroxine suppression therapy and thyroid stimulating hormone (TSH) should not be elevated -no prior treatment with E7080 -no anti-cancer therapy or surgery within 3 weeks -no active infections, bleeding problems, cardiovascular impairment, gastrointestinal malabsorption, or significant protein in the urine - disease-free of any prior malignancy for 2 years
E7080,a VEGF-inhibitor,is an oral medication given on an out-patient basis once every day.Subjects will be randomized to receive E7080 orally daily or a Placebo. Subjects and health care providers will not know which treatment the subject is receiving.Cycles are 28 days and disease status is re-evaluated every 2 cycles. At the time of disease progression, subjects receiving placebo will have the option to receive treatment with open-label E7080. There are several ancillary blood samples collected throughout the trial.
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