EUCTR2009-012945-49-GB进行中（未招募）1 期
A Phase II Trial of Nilotinib in the Treatment of Patients with c-KIT Mutated Advanced Acral and Mucosal Melanoma (NICAM) - Nilotinib in the Treatment of c-KIT Mutated Melanoma (NICAM)
Royal Marsden Hosptial Foundation Trust0 个研究点目标入组 29 人开始时间: 2009年9月17日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 29
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
- •Inclusion Criteria
- •1. Patients with c-KIT mutated histologically proven advanced mucosal or acral melanoma in which the mutation is not known to be associated with nilotinib resistance.
- •2. Unresectable locally advanced or metastatic disease
- •3. The presence of one or more clinically or radiologically measurable lesions at least 10mm in size
- •4. ECOG performance status 0, 1 or 2
- •5. Life expectancy greater than 12 weeks
- •6. At least 28 days since major surgery and 7 days since skin/tumour biopsy
- •7. The capacity to understand the patient information sheet and the ability to provide written informed consent
- •8. Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests and other study procedures
- •9. Age 18 or greater
- •10. Women must be postmenopausal (no menstrual period for a minimum of 1 year) or have a negative serum pregnancy test on entry in the study (even if surgically sterilised). Men and women of childbearing potential must use adequate birth control measures (e.g. abstinence, oral contraceptives, intrauterine device, barrier method with spermicide, implantable or injectable contraceptives or surgical sterilization) for the duration of the study and should continue such precautions for 6 months after receiving the last study treatment
- •11. Serum alanine transaminase (ALT) =2.5 x upper limit of normal (ULN), total serum bilirubin =1.5 x ULN
- •12. Serum creatinine =1.5 x ULN
- •13. Haemoglobin =9.0 g/dL, absolute neutrophil count =1.5 x 109/L, platelets =100 x 109/L
- •14. Prothrombin time (PT) =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
- •Exclusion Criteria
- •1. 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
- •2. Women who are pregnant, nursing, or planning pregnancy within 6 months after the last treatment
- •3. Men who plan to father a child within 6 months of the last treatment
- •4. Use of any investigational drug within 30 days prior to screening
- •5. Significant cardiac disease including patients who have or who are at significant risk of developing prolongation of QTc
- •6. Severe and/or uncontrolled medical disease
- •7. Known chronic liver disease
- •8. Known HIV infection
- •9. Previous radiotherapy to 25% or more of the bone marrow and/or radiation therapy in the 4 weeks prior to study entry
- •10. Prior exposure to a tyrosine kinase inhibitor
研究者
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