EUCTR2006-006615-80-GB进行中（未招募）1 期
A Pilot Study in Metastatic Advanced Thyroid Cancer Evaluating the Safety and Efficacy of Sorafenib - MATiSSe
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 33
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
入选标准
- •1. Human subjects with advanced / metastatic differentiated or medullary thyroid carcinoma
- •2. Patients must have one of the following histological sub-types
- •- Any papillary subtypes including follicular variants, tall cell, columnar cell and diffuse sclerosing,
- •- Any follicular, hurthle cell or medullary
- •3. Patients must be deemed not suitable for radio active iodine therapy
- •4. Must have uni-dimensional measurable disease on CT or MRI according to Response Evaluation Criteria of Solid tumours (RECIST)
- •5. Lesions which are accessible for low risk biopsy
- •6. Male/female subjects age 18 years or greater
- •7. Patients with ECOG performance status 0, 1 see appendix 3
- •8. Life expectancy greater than 12 weeks
- •9. The cognitive capacity to understand patient information sheets and give written informed consent and be able to comply with follow up requirements
- •10. Women must be post-menopausal (no menstrual period for at least a year) or have a negative pregnancy serum test on entry into the study (even if surgically sterilized)
- •Patients must refrain from becoming pregnant throughout their treatment and for upto 6 months after stopping study drug. They must be on adequate contraception (abstinence, oral contraceptives, barrier method with spermicide, implantable or injectable contraceptive or surgical sterilization) throughout this period.
- •Patients must have adequate renal, liver and haematological function
- •11 Serum creatinine = 1.5 x ULN
- •12. Serum aspartate transaminase and alanine transaminase = 2.5 x ULN
- •13. Total serum bilirubin = 1.5 x ULN
- •14. Amylase and lipase < 1.5 x ULN
- •15. Haemoglobin = 9.0g/dl
- •16. Absolute neutrophil count = 1.5 x 109 mm3
- •17. Platelets = 100 x 109/L
- •18. Prothombin time = 1.5 x ULN
- •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
排除标准
- •A patient will not be eligible for inclusion in this study if any of the following apply
- •1. Anaplastic and poorly differentiated carcinoma of the thyroid
- •2. Previous malignancy except cervical cis, Basal cell carcinoma or superficial bladder cancer
- •3. Patients with recent or active bleeding diathesis
- •4. HIV infection or chronic Hepatitis B or C
- •5. Concomitant rifampicin and Hypericum perforatum also known as St. John’s wort
- •6. Patients with congestive heart failure greater than NYHA functional class II (symptomatic during ordinary activity; (see Appendix 5)
- •7. Patients with cardiac arrhythmias greater than Grade 1 NCI CTCAE, Version 3.0 (see appendix 2) (conduction abnormality and supraventricular arrhythmia present but patient is asymptomatic, intervention not indicated, palpitations present and QTc > 0.45-0.47 second).
- •8. Patients with active coronary artery disease or ischemia.
- •9. Patients with Child-Pugh class C hepatic impairment (see appendix 4)
- •10. Patients with severe renal impairment (calculated creatinine clearance of < 30 ml/min) or who require dialysis.
- •11. Patients with uncontrolled hypertension or hypertension treated with 2 or more anti-hypertensive agents
- •12. Intracranial disease, unless there has been radiological evidence of stable intracranial disease > 6 months. In the case of a solitary brain metastasis, evidence of a disease-free interval of at least 3 months post surgery. All patients previously treated for brain metastases must be stable off corticosteroid therapy for at least 28 days
- •13. Previous treatment with a tyrosine kinase inhbitor or anti-angiogenic agent (licensed or investigational) such as sunitinib or bevacizumab
- •14. Any drug (licensed or investigational) that targets the RAS, VEGF, VEGFR or EGFR pathway
- •15. Significant surgery within 4 weeks of start of study
- •16. Investigational drug therapy during or within 30 days
- •17. Any cancer chemotherapy, immunotherapy, radiotherapy or hormonal treatment over the last 4 weeks. Palliative radiotherapy to symptomatic disease sites is permitted
- •Concurrent anti-cancer chemotherapy, immunotherapy or hormonal therapy except biphosphanates
- •18. Women who are pregnant, breast feeding, or planning pregnancy within 6 months after the last treatment (this includes men who plan to father a child within 6 months of the last treatment)
- •19. History of alcohol or substance abuse within the preceding 6 months that, in the opinion of the investigator, may increase the risks associated with study participation or study agent administration, or may interfere with interpretation of results
- •20. Recent thromboembolic events including MI
- •21. Need for anti-coagulant therapy (except low dose aspirin)
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