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

Sponsored by:	Eisai Medical Research Inc.
Information provided by:	Eisai Medical Research Inc.
ClinicalTrials.gov Identifier:	NCT00784303

Purpose

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.

Condition	Intervention	Phase
Thyroid Cancer	Drug: E7080	Phase II

MedlinePlus related topics: Cancer Thyroid Cancer

Drug Information available for: Iodine Cadexomer iodine Sodium iodide I 131 Thyroid

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
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

Further study details as provided by Eisai Medical Research Inc.:

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

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 ]

Estimated Enrollment:	100
Study Start Date:	October 2008
Estimated Primary Completion Date:	February 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: E7080 E7080 given orally continuously at 10 mg, twice a day.

Detailed Description:

This will be an open-label study at approximately 40 study centers in the US, Europe and other countries. The study will consist of a screening period, 28-day treatment cycles, 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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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 criteria:

-- Radiographically measurable disease defined as at least one lesion that can be accurately measured in 1 dimension as at least 20 mm by conventional CT or MRI techniques or as at least 10 mm by spiral CT scan.
Patients must show evidence of disease progression by RECIST using site assessment of CT/MRI scans within 6 months (+ 1 month to allow for variances in patients scanning intervals) prior to study entry.
Patients with DTC must be 131-I refractory/resistant disease: never demonstrated 131-I uptake or 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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00784303

Contacts

Contact: Eisai Medical Services

1-888-422-4743

Show 25 Study Locations

Sponsors and Collaborators

Eisai Medical Research Inc.

Investigators

Study Director:

Hamadi Zouabi, MD

Eisai Limited

More Information

Responsible Party:	Eisai Limited ( Hamadi Zouabi, M.D., Director of Oncology )
Study ID Numbers:	E7080-G000-201, EudraCT Number: 2007-005933-12
Study First Received:	October 30, 2008
Last Updated:	November 11, 2008
ClinicalTrials.gov Identifier:	NCT00784303
Health Authority:	United States: Food and Drug Administration; European Union: European Medicines Agency

Keywords provided by Eisai Medical Research Inc.:

Thyroid
cancer

Study placed in the following topic categories:

Thyroid Neoplasms
Head and Neck Neoplasms
Iodine
Endocrine System Diseases

Endocrinopathy
Thyroid Diseases
Endocrine Gland Neoplasms

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on January 16, 2009