Evaluating the Safety and Efficacy of Oral E7080 in Medullary and Iodine-131 Refractory, Unresectable Differentiated Thyroid Cancers, Stratified by Histology
The purpose of this study is to determine the safety and efficacy of oral E7080 in medullary and iodine-131 refractory, unresectable differentiated thyroid cancers.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||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|
- Determine the effect of E7080 on the objective tumor response rate according to Response Evaluation Criteria in Solid Tumors (RECIST). [ Time Frame: Months 2, 4, 6, 8 and every two months thereafter. ] [ Designated as safety issue: No ]
- Adverse events, laboratory assessments, and electrocardiograms (ECGs). [ Time Frame: AEs reported during all cycles; labs at each week in Cycle 1 and Day 1 at other cycles; ECGs at Day 1 of each cycle ] [ Designated as safety issue: Yes ]
- Progression-free survival, duration of response, and time to response. [ Time Frame: At 12 weeks and 6 months ] [ Designated as safety issue: No ]
- Overall Survival. [ Time Frame: At 6 and 12 months, every 3 months in 1st 2 years off study, every 6 months in Years 3 & 4, and yearly thereafter ] [ Designated as safety issue: No ]
- Pharmacokinetic profile. [ Time Frame: Days 1 and 8 of Cycle 1 and Day 1 of other cycles ] [ Designated as safety issue: No ]
|Study Start Date:||August 2009|
|Estimated Study Completion Date:||October 2013|
|Primary Completion Date:||December 2011 (Final data collection date for primary outcome measure)|
E7080 given orally continuously at 24 mg, once a day.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00784303
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