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Therapeutic Areas: Oncology
Disease Category: Thyroid Cancer

Trial Information

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

Phase II, Multicenter, Open-Label, Single-Arm Trial to Evaluate the Safety and Efficacy of Oral E7080 in Medullary and Iodine-131 (131 I) Refractory, Unresectable Differentiated Thyroid Cancers, Stratified by Histology

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.

Patient 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

Kelly Colucci, Manager, Grants and Contracts
Atlantic Health System
475 South Street
Morristown, NJ 07962
Phone: 973-660-3139
EMail: kelly.colucci@atlantichealth.org

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