A Multicenter Phase 1B Pharmacodynamics Study of MRX34, MicroRNA miR-Rx34 Liposomal Injection, in Patients With Advanced Melanoma and Biopsy Accessible Lesions
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 主要终点
- Peak blood concentration and Area Under the Curve (AUC) of MRX34 after IV dosing and drug concentration in tissue biopsies
研究概览
简要总结
This study is designed to investigate the biomarkers, pharmacodynamics and pharmacokinetics of the liposomal micro-ribonucleic acid-34 (microRNA-34, miR-34). Melanoma patients with easily accessible lesions will undergo serial biopsies and serial blood samples will be collected.
详细描述
MRX34 Induction Therapy consists of 3 cycles of MRX34 treatment given over an approximately 8 week period. Dexamethasone 10 mg PO (or IV) will be given as premedication. On Days 1-5 of each treatment cycle, MRX34 will be given as a daily infusion followed by 16 days of rest. At screening a tumor biopsy sample will be required from all patients. Additional biopsies will be collected at Cycle 1 Day 3 and the end of Cycles 1 and 3 (Day 18 +/- 1 day)
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 95 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥18 years of age
- •Advanced or metastatic cutaneous, acral or mucosal melanoma
- •Tumor lesions accessible to serial biopsies
- •ANC ≥, Plts ≥100,000 /mm3
排除标准
- •Serious active non-malignant disease
- •Central Nervous System metastasis
研究组 & 干预措施
Treatment with MRX34
Liposomal Injection of MRX34 for 5 days followed by 16 days rest with premedication of dexamethasone daily.
干预措施: MRX34 (Drug)
Treatment with MRX34
Liposomal Injection of MRX34 for 5 days followed by 16 days rest with premedication of dexamethasone daily.
干预措施: Dexamethasone (Drug)
结局指标
主要结局
Peak blood concentration and Area Under the Curve (AUC) of MRX34 after IV dosing and drug concentration in tissue biopsies
时间窗: 3 months
次要结局
- Frequency and severity of adverse events associated with MRX34 treatment(6 months)