EUCTR2005-001161-34-GB进行中（未招募）1 期
Phase I-II multicenter, randomized, open-label, clinical and pharmacokinetic study of plitidepsin, administered alone or in combination with dacarbazine, as front-line therapy to subjects with unresectable advanced melanoma - Not available
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 60
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.Voluntary written informed consent
- •2.Malignant melanoma histologically proven
- •3.Advanced melanoma
- •4.Age from 18 years
- •5. measurable disease
- •6.Recovery from any non-hematologic drug-related adverse event derived from previous treatment
- •7.Laboratory values within 14 days prior to first infusion:
- •·Aspartate aminotransferase (AST) = 2.5 x ULN
- •·Alanine aminotransferase (ALT) = 2.5 x ULN
- •8.Performance status
- •9.Life expectancy > 3 months
- •10.Left ventricular ejection fraction (LVEF) within normal limits
- •11. negative serum pregnancy and Acceptable methods of contraception
- •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
- •1. prior systemic therapy for the treatment of metastatic melanoma
- •2.Subjects relapsing / progressing within 6 months after the end of adjuvant or neo-adjuvant systemic drug therapy for non-metastatic melanoma
- •3. loco-regional melanoma previously treated with loco-regional drug therapy with disease relapse or progression within the treated area
- •4.Subjects for whom surgery would be expected to result in cure or significant palliation
- •5.Less than 4 weeks from radiation therapy
- •6.Evidence of progressive CNS metastases or any symptomatic brain or leptomeningeal metastases
- •7.Other relevant diseases or adverse clinical conditions:
- •. History or presence of unstable angina, myocardial infarction, valvular heart disease or congestive heart failure
- •·Previous mediastinal radiotherapy
- •·Uncontrolled arterial hypertension despite optimal therapy
- •·Any grade of Cardiac arrhythmia according to CTCAE v3.0 (see Appendix 6)
- •8.Pregnant or lactating women
- •9.Limitation of the patient’s ability to comply with the treatment or follow-up procedures and visits defined in the study protocol
- •10.Known hypersensitivity to any component of the study drug products, including plitidepsin, dacarbazine, cremophor, mannitol, citrate, or ethanol
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