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

Sponsor:	Eisai Inc.
Information provided by:	Eisai 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

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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Thyroid Cancer

Drug Information available for: Iodine Thyroid

U.S. FDA Resources

Further study details as provided by Eisai 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, 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 ]

Estimated Enrollment:	104
Study Start Date:	August 2009
Estimated Primary Completion Date:	October 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: E7080 E7080 given orally continuously at 24 mg, once a day.

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.

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 criterion:
1. 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)
2. 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.

Contacts and Locations

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

Contacts

Contact: Eisai Medical Services

1-888-422-4743

Show 66 Study Locations

Sponsors and Collaborators

Eisai Inc.

Investigators

Study Director:

Hamadi Zouabi, MD

Eisai Limited

More Information

No publications provided

Responsible Party:	Eisai Limited ( Hamadi Zouabi, M.D., Director of Oncology )
Study ID Numbers:	E7080-G000-201
Study First Received:	October 30, 2008
Last Updated:	September 10, 2009
ClinicalTrials.gov Identifier:	NCT00784303 History of Changes
Health Authority:	United States: Food and Drug Administration; European Union: European Medicines Agency

Keywords provided by Eisai Inc.:

Thyroid Cancer

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Thyroid Neoplasms
Head and Neck Neoplasms

Endocrine System Diseases
Thyroid Diseases
Endocrine Gland Neoplasms

ClinicalTrials.gov processed this record on February 08, 2010