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.
Interventional
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.
No
United States: Food and Drug Administration
E7080-G000-201
NCT00784303
August 2009
October 2013
Name | Location |
---|---|
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 | |
Denver, Colorado | |
Baltimore, Maryland 21287 | |
Boston, Massachusetts | |
Milwaukee, Wisconsin | |
Lebanon, New Hampshire |