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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00784303
Recruitment Status : Completed
First Posted : November 3, 2008
Last Update Posted : August 8, 2014
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment Phase
Thyroid Cancer Drug: E7080 Phase 2

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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 116 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : August 2009
Primary Completion Date : April 2011
Study Completion Date : September 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: 1 Drug: E7080
E7080 given orally continuously at 24 mg, once a day.

Outcome Measures

Primary Outcome Measures :
  1. 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. ]

Secondary Outcome Measures :
  1. 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 ]
  2. Progression-free survival, duration of response, and time to response. [ Time Frame: At 12 weeks and 6 months ]
  3. 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 ]
  4. Pharmacokinetic profile. [ Time Frame: Days 1 and 8 of Cycle 1 and Day 1 of other cycles ]

Eligibility Criteria

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion criteria:

  1. Patients must have histologically or cytologically confirmed diagnosis of Medullary Thyroid Cancer (MTC) or Differentiated Thyroid Cancer (DTC).
  2. 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
  3. 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.
  4. 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).
  5. Well controlled blood pressure prior to study entry.
  6. Signed informed consent.

Exclusion criteria:

  1. Anaplastic thyroid carcinoma, thyroid lymphoma, mesenchymal tumors of the thyroid, metastases to the thyroid.
  2. Brain or leptomeningeal metastases.
  3. 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).
  4. Marked baseline prolongation of QT/QTc interval.
  5. Proteinuria > 1+ or > 30 mg in dipstick testing.
  6. Active hemoptysis (bright red blood of at least ½ teaspoon) in the 28 days prior to study entry.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00784303

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Sponsors and Collaborators
Eisai Inc.
More Information

Responsible Party: Eisai Inc.
ClinicalTrials.gov Identifier: NCT00784303     History of Changes
Other Study ID Numbers: E7080-G000-201
First Posted: November 3, 2008    Key Record Dates
Last Update Posted: August 8, 2014
Last Verified: August 2014

Keywords provided by Eisai Inc.:
Thyroid Cancer

Additional relevant MeSH terms:
Thyroid Diseases
Thyroid Neoplasms
Endocrine System Diseases
Endocrine Gland Neoplasms
Neoplasms by Site
Head and Neck Neoplasms
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action