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 - ND

Phase 1

• Conditions: Medullary thyroid cancer [MTC] or radioiodine(131I) refractory/resistant differentiated thyroid cancer[DTC].; MedDRA version: 12.1Level: LLTClassification code 10065252Term: Solid tumor

• Registration Number: EUCTR2007-005933-12-IT
• Lead Sponsor: EISAI LIMITED

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-11-26
• Last Update Posted: 19 February 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 104

Inclusion Criteria

Patients must have histologically or cytologically confirmed diagnosis of MTC or DTC. Measurable disease meeting the following criteria (revised per Amendment 01): o 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 RECIST using either CT/MRI o Lesions that have had external beam radiotherapy (EBRT) must show evidence of progressive disease based on Modified RECIST to be deemed a target lesion Patients must show evidence of disease progression by RECIST using site assessment of CT/MRI scans within 12 months (+ 1 month to allow for variances in patients scanning intervals) prior to study entry (revised per Amendment 01). Patients with DTC must be 131I refractory/resistant defined by at least one of the following: a. One or more measurable lesions that have never demonstrated 131I uptake on any radioiodine scan based on either collected scans or reports, b. One or more measurable lesions with disease progression by RECIST within 12 months (+1 month to allow for variances in patient scanning intervals) of 131I therapy despite 131I uptake on radioiodine scan based on site assessment of CT/MRI scans (revised per Amendment 01). c. Cumulative activity of 131I of >600 mCi or 22 gigabequerel (GBq), with the last dose administered at least 6 months prior to study entry.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Anaplastic thyroid carcinoma, thyroid lymphoma, mesenchymal tumors of the thyroid, metastases to the thyroid Significant cardiovascular impairment (history of congestive heart failure > NYHA Class II, unstable angina or myocardial infarction within 6 months of study start, or serious cardiac arrhythmia) Active hemoptysis (bright red blood of at least ? teaspoon) in the 28 days prior to study entry

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified