EUCTR2008-008794-55-GB进行中（未招募）1 期
A randomised phase II study of sunitinib versus dacarbazine in the treatment of patients with metastatic uveal melanoma - SUAVE - Sunitinib versus dacarbazine in metastatic uveal melanoma
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 84
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
- •Patients with histologically or cytologically confirmed unresectable, metastatic uveal melanoma (histology must be available from a metastatic site)
- •Patients with disease that is not amenable to surgery, radiation, or combined modality therapy with curative intent
- •Patients who have not received any prior systemic therapy for advanced disease, including regional delivery of drug therapy (prior surgery or radiofrequency ablation is acceptable)
- •Patients who have received prior radiotherapy are eligible, however, measurable lesions must not have been previously irradiated
- •Patients with a life expectancy > 12 weeks
- •Patients who have ECOG Performance status 0, 1 or 2 (for ECOG scale of performance (see Appendix B)
- •Patient has at least one measurable target lesion, for further evaluation according to the Response Evaluation Criteria In Solid Tumours - RECIST version 1.1 (see Appendix C - contrast enhancing lesion with the largest diameter >10mm, based on spiral CT scan or MRI) done within 28 days of randomisation)
- •Patient is aged > 18 years
- •Patient has adequate haematological, renal and liver function as defined below and performed within 7 days of randomisation:
- •oHb > 10 g/dl, platelets > 100x109/L, WCC > 3.0 x109/L, ANC > 1.0x109/L
- •oBili < 1.5 x ULN, Alk phos < 5 x ULN, AST and ALT < 5 x ULN
- •oCr < 1.5 x ULN
- •Patient has provided written informed consent
- •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
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 0
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 0
排除标准
- •Patients who have:
- •Conjunctival melanoma
- •Received any previous systemic therapy for metastatic uveal melanoma
- •Known leptomeningeal or brain metastases
- •Had treatment with potent CYP3A4 inhibitors and inducers within 7 and 12 days respectively, prior to study treatment administration
- •Concomitant treatment with therapeutic doses of anticoagulants (low dose warfarin up to 2mg PO daily for deep vein thrombosis prophylaxis is allowed)
- •Unstable systemic diseases including uncontrolled hypertension (>150/100 mmHg despite optimal medical therapy) or active uncontrolled infections.
- •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 ischemic attack, or pulmonary embolism.
- •Clinically significant abnormal cardiac function with abnormal 12 lead ECG. Ongoing cardiac dysrhythmias of NCI CTCAE grade 2 or greater, poorly controlled atrial fibrillation of any grade, or prolongation of the QTc interval to >450 msec for males or >470 msec for females.
- •Any other serious or uncontrolled illness which, in the opinion of the investigator, makes it undesirable for the patient to enter the trial
- •Any medical or psychiatric condition which would influence the ability to provide informed consent
- •Pregnant or lactating women
- •Lack of informed consent
- •Any previous investigational agent within the last 12 weeks
- •Pregnant or lactating females
- •Patients who have not provided informed consent
- •Any medical or psychiatric condition which would influence the ability to provide informed consent
- •Patients with a history of prior malignant disease (unless 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.
研究者
相似试验
终止
2 期
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