A Trial of Lenvatinib (E7080) in Radioiodine (131 I)-Refractory Differentiated Thyroid Cancer in China

Inclusion criteria

• ✓. Participants must have histologically or cytologically confirmed diagnosis of one of the following Differentiated Thyroid Cancer (DTC) subtypes:
• ✓. Measurable disease meeting the following criteria and confirmed by central radiographic review:
• ✓. At least 1 lesion of ≥ 1.0 centimeter (cm) in the longest diameter for a non- lymph node or ≥ 1.5 cm in the short-axis diameter for a lymph node which is serially measurable according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 using computerized tomography/magnetic resonance imaging (CT/MRI). If there is only one target lesion and it is a non-lymph node, it should have a longest diameter of ≥ 1.5 cm.
• ✓. Lesions that have had external beam radiotherapy (EBRT) or locoregional therapies such as radiofrequency (RF) ablation must show evidence of progressive disease (substantial size increase of ≥ 20%) to be deemed a target lesion.
• ✓. Participants must show evidence of disease progression comparing (a) scan in screening and (b) historical scan obtained within 12 months prior to signing informed consent, according to RECIST 1.1 assessed and confirmed by central radiographic review of CT and/or MRI scans.
• ✓. Participants must not be eligible for possible curative surgery and must be radioiodine (131 I)- refractory / resistant as defined by at least one of the following:
• ✓. One or more measurable lesions that do not demonstrate iodine uptake on any radioiodine scan
• ✓. One or more measurable lesions that has progressed by RECIST 1.1 within 12 months of 131 I therapy, despite demonstration of radioiodine avidity at the time of that treatment by pre- or post-treatment scanning.

Exclusion criteria