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

Phase 2

Active, not recruiting

• Conditions: Cancer - Thyroid; Thyroid Cancer

• Registration Number: ACTRN12609000002280
• Lead Sponsor: Eisai Inc

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-01-06
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Active, not recruiting
• Sex: All
• Target Recruitment: 100

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 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 Computed tomography (CT) or magnetic resonance imaging (MRI) techniques or as at least 10 mm by spiral CT scan.

3.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.

4.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).

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Determine the effect of E7080 on the objective tumor response rate according to Response Evaluation Criteria in Solid Tumors (RECIST).[Months 2, 4, 6, 8 and every two months until all participants have completed 8 cycles of treatment or are off study treatment which ever occurs first.]