Evaluating the Safety and Efficacy of Oral E7080 in Medullary and Iodine-131 Refractory, Unresectable Differentiated Thyroid Cancers, Stratified by Histology

This study is ongoing, but not recruiting participants.

Sponsor:

Information provided by (Responsible Party):

Eisai Inc.

ClinicalTrials.gov Identifier:

NCT00784303

First received: October 30, 2008

Last updated: September 5, 2012

Last verified: September 2012

History of Changes

Tracking Information
First Received Date ^ICMJE	October 30, 2008
Last Updated Date	September 5, 2012
Start Date ^ICMJE	August 2009
Primary Completion Date	December 2011 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: October 31, 2008)	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 ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00784303 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: September 10, 2009)	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 ]
Original Secondary Outcome Measures ^ICMJE (submitted: October 31, 2008)	Adverse events, laboratory assessments, ECGs, progression-free survival, duration of response, time to response, PK profile. [ Time Frame: Months 2, 4, 6, 8 and every two months thereafter. ] [ Designated as safety issue: Yes ]
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Evaluating the Safety and Efficacy of Oral E7080 in Medullary and Iodine-131 Refractory, Unresectable Differentiated Thyroid Cancers, Stratified by Histology
Official Title ^ICMJE	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
Brief Summary	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.
Detailed Description	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.
Study Type ^ICMJE	Interventional
Study Phase	Phase 2
Study Design ^ICMJE	Allocation: Non-Randomized Endpoint Classification: Pharmacokinetics/Dynamics Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Thyroid Cancer
Intervention ^ICMJE	Drug: E7080 E7080 given orally continuously at 24 mg, once a day.
Study Arm (s)	Experimental: 1 Intervention: Drug: E7080
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Active, not recruiting
Estimated Enrollment ^ICMJE	104
Estimated Completion Date	October 2013
Primary Completion Date	December 2011 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion criteria: Patients must have histologically or cytologically confirmed diagnosis of Medullary Thyroid Cancer (MTC) or Differentiated Thyroid Cancer (DTC). Measurable disease meeting the following criterion: At least one lesion (≥ 1.5 cm in longest diameter for non-lymph nodes and ≥2.0 cm in longest diameter for lymph nodes) which is serially and accurately measurable according to Modified Response Evaluation Criteria in Solid Tumors (RECIST) using either computed tomography (CT) or magnetic resonance imaging (MRI) Lesions that have had electron beam radiotherapy must show evidence of progressive disease based on Modified Response Evaluation Criteria in Solid Tumors (RECIST) to be deemed a target lesion Patients must show evidence of disease progression by Response Evaluation Criteria in Solid Tumors (RECIST) using site assessment of computed tomography/magnetic resonance imaging (CT/MRI) scans within 12 months (+1 month to allow for variances in patient scanning intervals) prior to study entry. Patients with Differentiated Thyroid Cancer (DTC) must be 131-I refractory/resistant: never demonstrated 131-I uptake, progression despite 131-I uptake, or cumulative dose of 131-I of > 600 mCi (last dose given at least 6 months prior to study entry). Well controlled blood pressure prior to study entry. Signed informed consent. Exclusion criteria: Anaplastic thyroid carcinoma, thyroid lymphoma, mesenchymal tumors of the thyroid, metastases to the thyroid. Brain or leptomeningeal metastases. Significant cardiovascular impairment (history of congestive heart failure > New York Heart Association [NYHA] Class II, unstable angina or myocardial infarction within 6 months of study start, or serious cardiac arrhythmia). Marked baseline prolongation of QT/QTc interval. Proteinuria > 1+ or > 30 mg in dipstick testing. Active hemoptysis (bright red blood of at least ½ teaspoon) in the 28 days prior to study entry.
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States, Australia, France, Germany, Italy, Poland, United Kingdom

Administrative Information
NCT Number ^ICMJE	NCT00784303
Other Study ID Numbers ^ICMJE	E7080-G000-201
Has Data Monitoring Committee	No
Responsible Party	Eisai Inc.
Study Sponsor ^ICMJE	Eisai Inc.
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Eisai Inc.
Verification Date	September 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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