ISRCTN75033520终止2 期
A randomised Phase II study of sunitinib versus dacarbazine in the treatment of patients with metastatic uveal melanoma
Clatterbridge Centre for Oncology NHS Foundation Trust (UK)0 个研究点目标入组 124 人开始时间: 2010年10月29日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 124
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Patients with histologically or cytologically confirmed unresectable, metastatic uveal melanoma (histology must be available from a metastatic site)
- •2. Patients with disease that is not amenable to surgery, radiation, or combined modality therapy with curative intent
- •3. No prior systemic therapy for advanced disease, including regional delivery of drug therapy (prior surgery or radiofrequency ablation is acceptable)
- •4. Patients who have received prior radiotherapy are eligible, however, measurable lesions must not have been previously irradiated
- •5. Life expectancy greater than 12 weeks
- •6. Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2 (for ECOG scale of performance)
- •7. At least one measurable target lesion, for further evaluation according to the Response Evaluation Criteria In Solid Tumours (RECIST) version 1.1
- •8. Aged greater than 18 years, either sex
- •9. Adequate haematological, renal and liver function as defined below and performed within 14 days of study inclusion:
- •9.1. Haemoglobin (Hb) greater than 10 g/dl, platelets greater than 100,000 mm3, white cell count (WCC) greater than 3.0 x 10^9/L, absolute neutrophil count (ANC) greater than 1.5 x 10^9/L
- •9.2. Bilirubin less than 1.5 x ULN, Alkaline phosphatase less than 5 x ULN, transaminases less than 5 x ULN
- •9.3. Creatinine less than 1.5 x ULN
- •10. Able to provide written informed consent
- •11. Females of child-bearing potential who have a negative pregnancy test prior to study entry and be using adequate contraception, which they agree to continue for 12 months after the study treatment
排除标准
- •1. Conjunctival melanoma
- •2. Received any previous systemic therapy for uveal melanoma
- •3. Known leptomeningeal or brain metastases
- •4. Patients with a history of prior malignant disease (only if they have had more than 3 years free of disease or have had adequately treated non-melanomatous skin cancer or in situ carcinoma of the cervix)
- •5. Had treatment with potent CYP3A4 inhibitors and inducers within 7 and 12 days respectively, prior to study treatment administration
- •6. Therapeutic anticoagulation for treatment of DVT/PE. Concomitant treatment with therapeutic doses of anticoagulants (low dose warfarin [Coumadin®] up to 2 mg PO daily for deep vein thrombosis prophylaxis is allowed).
- •7. Unstable systemic diseases including uncontrolled hypertension (greater than 150/100 mmHg despite optimal medical therapy) or active uncontrolled infections
- •8. Any of the following within the 6 months prior to study drug administration: myocardial infarction, severe/unstable angina, symptomatic congestive heart failure, cerebrovascular accident or transient ischaemic attack, or pulmonary embolism
- •9. Clinically significant abnormal cardiac function with abnormal 12-lead electrocardiogram (ECG). Ongoing cardiac dysrhythmias of National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) grade more than or equal to grade 2, poorly controlled atrial fibrillation of any grade, or prolongation of the QTc interval to greater than 450 msec for males or greater than 470 msec for females.
- •10. Any other serious or uncontrolled illness which, in the opinion of the investigator, makes it undesirable for the patient to enter the trial
- •11. Any medical or psychiatric condition which would influence the ability to provide informed consent
- •12. Pregnant or lactating women
- •13. Lack of informed consent
- •14. Any previous investigational agent within the last 12 weeks
研究者
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