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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


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Thyroid Cancer

Thank you

Trial Information

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


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.

Inclusion Criteria


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.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Determine the effect of E7080 on the objective tumor response rate according to Response Evaluation Criteria in Solid Tumors (RECIST).

Outcome Time Frame:

Months 2, 4, 6, 8 and every two months thereafter.

Safety Issue:

No

Authority:

United States: Food and Drug Administration

Study ID:

E7080-G000-201

NCT ID:

NCT00784303

Start Date:

August 2009

Completion Date:

October 2013

Related Keywords:

  • Thyroid Cancer
  • Thyroid Cancer
  • Thyroid Neoplasms
  • Thyroid Diseases

Name

Location

Hinsdale, Illinois  60521
Alexandria, Minnesota  56308
Albany, Georgia  31701
Fountain Valley, California  92708
Miami, Florida  33176
Columbia, Missouri  65203
Cleveland, Ohio  44195
Philadelphia, Pennsylvania  19104
Austin, Texas  78705
Seattle, Washington  98195
Little Rock, Arkansas  72205-7199
Hackensack, New Jersey  07601
Denver, Colorado  
Baltimore, Maryland  21287
Boston, Massachusetts  
Milwaukee, Wisconsin  
Lebanon, New Hampshire