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.

Eisai Limited0 个研究点目标入组 104 人开始时间: 2009年6月10日最近更新: 2020年7月27日

试验速览

阶段: 1 期
状态: 进行中（未招募）
发起方: Eisai Limited
入组人数: 104

研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型: Interventional clinical trial of medicinal product

入排标准

性别: All

入选标准

•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)
•-Papillary classical (Added per Amendment 02)
•-Papillary follicular variant (Revised per Amendment 02)
•-Papillary 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) (Revised per Amendment 02)
•b.Follicular thyroid cancer (FTC)
•-Follicular invasive: minimally or widely (Added per Amendment 02)
•-Hürthle cell
•-Clear cell
•2.Measurable disease meeting the following criterion (revised per Amendment 01):
•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 (revised per Amendment 01).
•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 (revised per Amendment 01).
•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.
•5.( Moved to Criterion 2 per Amendment 1)
•5.Patients must have unresectable disease. Patients must not be amenable to surgery.
•6.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.
•7.Patients must not have had chemotherapy, major surgery, monoclonal antibody therapy or experimental therapy within the 30 days prior to the start of E7080 administration (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 [PTK787/ZK 222584], VEGF Trap, and ZD6474) is allowed with at least 30 days between this therapy and the start of E7080 treatment.
•8.All chemotherapy or radiation-related toxicities must have resolved to < Grade 2 severity, except alopecia and infertility.
•9.Prior thyroidectomy is allowed.
•10.Blood pressure should be well controlled (=140/90 mm Hg at Pre-Treatment) with or without antihypertensive medications (revised per Amendment 01).

排除标准

•Patients with any one of the following are not eligible to participate in this study:
•1.Anaplastic thyroid carcinoma, thyroid lymphoma, mesenchymal tumors of the thyroid, metastases to the thyroid
•2.Any of the following laboratory measurements:
•a.hemoglobin < 9 g/dL (5.6 mmol/L) (may be corrected with growth factor or transfusions);
•b.neutrophils < 1.5 x 109/L; platelets < 100 x 109/L
•c.bilirubin > 1.5 times the upper limit of normal (ULN) and other liver function tests (AST, ALT and alkaline phosphatase) with values greater than three times ULN; (in the case of liver metastases > five times ULN). If alkaline phosphatase is greater than three times the ULN (in the absence of liver metastasis) or greater than five times the ULN (in the presence of liver metastasis), and the patient is known to have bone metastasis, the liver specific alkaline phosphatase must be separated from the total and the liver specific alkaline phosphatase alone should be used to assess liver function
•d.Creatinine clearance is greater than or equal to 60 mL/min per the Cockcroft and Gault formula, patient is eligible (Appendix 9) (revised per Amendment 02)
•3.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)
•4.Active hemoptysis (bright red blood of at least ½ teaspoon) in the 28 days prior to study entry
•5.Bleeding or thrombotic disorders or use of anticoagulants, such as warfarin, with a therapeutic international normalized ratio (INR)
•6.Positive history of HIV, active hepatitis B or active hepatitis C or severe/uncontrolled intercurrent illness or infection
•7.Organ allografts requiring immunosuppressive treatment
•8.Prior malignancy, other than non-melanoma skin cancer or cervical carcinoma in situ, unless the prior malignancy was diagnosed and definitively treated = 5 years previously with no subsequent evidence of recurrence
•9.Brain or leptomeningeal (central nervous system [CNS]) metastases. Patients with stable or previously irradiated brain metastases are also excluded (Revised per Amendment 01)
•10.Marked baseline prolongation of QT/QTc interval (QTc interval = 500 msec) using the Fridericia method (QTc = QT/RR0.33) for QTc analysis
•11.> 1+ proteinuria on urine dipstick testing or >30 mg/dL. Patients with proteinuria > 1+ on urine dipstick testing will undergo 24-hour urine collection for quantitative assessment of proteinuria. Subjects with 24-hour protein =1 g/24 hours will be ineligible (revised per Amendment 02).
•12.History of gastrointestinal malabsorption or having undergone surgery requiring gastrointestinal anastomoses within 4 weeks of starting therapy or who have not recovered from major surgery within 4 weeks of starting therapy
•13.Women who are pregnant or breast-feeding; women of childbearing potential with a positive pregnancy test at Pre-Treatment or no pregnancy test. Women of childbearing potential unless (1) surgically sterile or (2) using adequate measures of contraception (including two forms of contraception, one of which must be a barrier method) in the opinion of the investigator (revised per Amendment 01)
•Perimenopausal women must be amenorrheic for at least 12 months to be considered of non childbearing potential.
•Fertile males with female partners who are not willing to use contraception or whose female partners are not using adequate contra

研究者

发起方

Eisai Limited

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