Phase II, Multicenter, Open-label, Single Arm Trial to Evaluate the Safety and Efficacy of Oral E7080 in Medullary and Iodine-131 Refractory, Unresectable Differentiated Thyroid Cancers, Stratified by Histology
This will be an open-label study at approximately 50 study centers in the US, Europe and
other countries. The study will consist of a screening period (Pre-Treatment Phase), 28-day
treatment cycles (Treatment Phase), and a study termination/final visit and survival
follow-up. Patients showing clinical benefit will continue to receive the study drug
(Extension Phase) and will be followed up with the appropriate assessments.
Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Determine the effect of E7080 on the objective tumor response rate according to Response Evaluation Criteria in Solid Tumors (RECIST).
Months 2, 4, 6, 8 and every two months thereafter.
United States: Food and Drug Administration
|Hinsdale, Illinois 60521|
|Alexandria, Minnesota 56308|
|Albany, Georgia 31701|
|Fountain Valley, California 92708|
|Miami, Florida 33176|
|Columbia, Missouri 65203|
|Cleveland, Ohio 44195|
|Philadelphia, Pennsylvania 19104|
|Austin, Texas 78705|
|Seattle, Washington 98195|
|Little Rock, Arkansas 72205-7199|
|Hackensack, New Jersey 07601|
|Baltimore, Maryland 21287|
|Lebanon, New Hampshire|