| Inclusion Criteria: | 1) Patients must have histologically or cytologically confirmed diagnosis of one of the following: A. DTC, including any of the following subtypes: a. Papillary thyroid cancer (PTC): Follicular variant, Variants (including but not limited to tall cell, columnar cell, cribriform-morular, solid, oxyphil, Warthin's-like, trabecular, tumor with nodular fasciitis-like stroma, Hürthle cell variant of papillary carcinoma, poorly differentiated). b. Follicular thyroid cancer (FTC): Hürthle cell, Clear cell, Insular. B. MTC.
2) Measurable disease meeting the following criterion: a. 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. b. Lesions that have had EBRT must show evidence of progressive disease based on Modified RECIST to be deemed a target lesion.
3) 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 patient scanning intervals) prior to study entry.
4) Patients with DTC must be 131I refractory/resistant as 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.
5) Patients with DTC must be 131I refractory/resistant as defined by at least one of the following:c. Cumulative activity of 131I of >600 mCi or 22 gigabequerels (GBq), with the last dose administered at least 6 months prior to study entry.
6) Patients must have unresectable disease. Patients must not be amenable to surgery.
7) Patients with DTC must be receiving thyroxine suppression therapy and TSH should not be elevated (TSH should be <= 5.50 mcu/mL) (revised per Amendment 01). When tolerated by the patient, thyroxine dose should be changed to achieve TSH suppression (TSH < 0.50 mcu/mL) and this dose can be changed concurrently upon starting E7080.
8) Patients must not have had chemotherapy, major surgery, monoclonal antibody therapy or experimental therapy within the 30 days prior to the start of E7080 (6 weeks for nitrosoureas or mitomycin C). Prior exposure to receptor tyrosine kinase inhibitors and antiangiogenic agents (including but not limited to AEE788, AG-013736, AMG706, AZD2171, bevacizumab, CP-547,632, dasatinib, enzataurin, imatinib mesylate, lenalidomide, pazopanib, sorafenib, sunitinib, thalidomide, vatalanib, VEGF Trap, and ZD6474) is allowed with at least 30 days between this therapy and the start of E7080 treatment.
9) All chemotherapy or radiation-related toxicities must have resolved to < Grade 2 severity, except alopecia and infertility.
10) Prior thyroidectomy is allowed.
11) Blood pressure should be well controlled (<= 140/90 mm Hg at Pre-Treatment) with or without antihypertensive medications.
12) Patients must be aged => 18 years.
13) Patients must have an ECOG Performance Status of 0 to 2.
14) Patients must have signed a written informed consent prior to any study specific Pre- Treatment procedures with the understanding that the patient may withdraw consent at any time without prejudice.
15) Patients must be willing and able to comply with the protocol guidelines for the duration of the study. |