DRKS00000635已完成1 期
Open label Phase I Study of Everolimus(RAD001) plus Doxorubicin in advanced progressive and refractory thyroid cancer - THYRADOX
niversitätsklinikum Halle (Saale)0 个研究点目标入组 14 人开始时间: 2010年12月10日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 14
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- N/a: Single Arm Study
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 one（—）
- 性别
- All
入选标准
- •1. Age = 18
- •2. Histologically or cytologically diagnosed thyroid cancer of follicular origin including papillary, follicular or poorly differentiated (insular or large-cell) thyroid cancer
- •3. Patients with progressive disease within 3 months according to RECIST-criteria or symptomatic disease (e.g. dyspnea due lung metastasis or bone pain) at the time of screening in the absence of documented disease progression with no further surgical treatment options and which are refractory or not susceptible to radioiodine treatment and if applicable, are refractory to treatment with sorafenib.
- •4. ECOG performance status = 2
- •5. Measurable lesion(s) according to RECIST-criteria v1.1
- •6. Adequate organ and bone marrow function
- •7. Agreement to use effective contraception while on treatment and for at least 3 months after end of treatment
- •8. Women of childbearing potential must have a negative urine or serum pregnancy test within 7 days prior to administration of RAD001
- •9. Signed informed consent and willingness and ability to comply with study procedures
排除标准
- •1. Previously received investigational sorafenib therapy within 4 weeks before enrolment in the study
- •2. Previous conventional chemotherapy or any investigational anticancer therapy other than sorafenib
- •3. Prior therapy with mTOR inhibitors
- •4. Second malignancy or history of malignancy within the last 5 years
- •5. Clinically significant active infection requiring antibiotic or antiretroviral therapy
- •6. Clinically active brain metastasis, uncontrolled seizure disorder, spinal cord compression, or carcinomatous meningitis
- •7. Medical history of clinically significant pulmonary or cardiovascular disease including chronic heart failure or myocardial infarction within 6 month prior to study enrollment or serious uncontrolled cardiac arrhythmia
- •8. Significant hepatic or hematological abnormality (i.e. transaminase levels > 2.5 x ULN, serum bilirubin > 1.5 x ULN, hemoglobin < 9g/dl, platelets < 120.000/mm³ or absolute neutrophile count < 1.500/mm³)
- •9. Serum creatinine > 1.5 x ULN
- •10. Uncontrolled hyperlipidemia : Fasting serum cholesterol > 300mg/dl or > 7.75mmol/l AND fasting triglycerides > 2.5 x ULN
- •11. Uncontrolled diabetes mellitus as defined by fasting serum glucose > 1.5 x ULN
- •12. Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of oral everolimus.
- •13. Patients with bleeding diathesis or an oral anti-vitamin K medication (except low dose warfarin)
- •14. A known history of HIV or HCV seropositivity
- •15. Pregnancy or breastfeeding
- •16. Situations that limit compliance with study requirements such as therapy schedules, lab investigations and other study procedures
- •17. Patients of childbearing/reproduction potential without highly effective contraception (PEARL-Index < 1%)
- •18. Patients with other significant disease or disorders that are considered contraindications according to the prescribing information for Doxorubicin or Affinitor or that, in the investigator’s opinion, would exclude the patient from the study
- •19. Patients who are incapable of giving legal informed consent
研究者
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