NCT00735332终止2 期
A Phase IIa Study of TLN-232 as Second-line Therapy for Patients With Metastatic Melanoma
Thallion Pharmaceuticals4 个研究点 分布在 2 个国家目标入组 49 人开始时间: 2008年8月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 49
- 试验地点
- 4
- 主要终点
- To assess the efficacy of TLN-232 in patients with recurrent metastatic melanoma measured by overall response rate at 16 weeks from date of initial infusion of TLN-232 (Day 1, Cycle 1).
研究概览
简要总结
The objective of this study is to assess the efficacy and safety of TLN-232 used to treat patients with metastatic melanoma that recur/progress after receiving first line systemic therapy.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed stage IV (M1a, M1b, and M1c) unresectable metastatic melanoma (cutaneous, mucosal or acral lentiginous)
- •First progression after treatment by one first line systemic therapy for metastatic melanoma (immunotherapy or targeted therapy or chemotherapy or any combination of them)
- •Measurable recurrent/progressive disease by radiological scan ≤ 21 days prior to Day 1, Cycle 1
- •Age ≥ 18 years
- •Normal organ and marrow function as defined below:
- •Leukocytes ≥2.5 x 109/L
- •Absolute neutrophil count ≥1.5 x 109/L
- •Platelets ≥100 x 109/L
- •Hemoglobin ≥100 g/L (10g/dL)
- •Total bilirubin ≤1.5 X institutional ULN
- •AST(SGOT)/ALT(SGPT) ≤2.5 X institutional ULN
- •Creatinine ≤1.5 X institutional ULN
排除标准
- •Patients with a life expectancy ≤ 16 weeks
- •Patients with ocular melanoma
- •Patients with symptomatic and/or unstable brain metastasis during the last 3 months (90 days) prior to Day 1, Cycle 1
- •Patients with a history of allergic reactions or hypersensitivity to somatostatin analogues
- •Patients with a documented history of HIV, active hepatitis B or C infection
- •Female patients who are pregnant or lactating
- •Patients who are receiving hormonal therapy (with the exception of hormone replacement therapy and hormonal contraceptives), systemic steroids, immunosuppressive therapy or coumadin (low molecular weight heparin is permitted)
- •Patients with grade ≥2 peripheral neuropathy (CTCAE criteria)
- •Patients in whom a proper central line cannot be established
研究组 & 干预措施
Single-Arm
Experimental
干预措施: TLN-232 (Drug)
结局指标
主要结局
To assess the efficacy of TLN-232 in patients with recurrent metastatic melanoma measured by overall response rate at 16 weeks from date of initial infusion of TLN-232 (Day 1, Cycle 1).
时间窗: Complete response, partial response or stable disease at 16 weeks from date of initial infusion of TLN-232 (Day 1, Cycle 1)
次要结局
- To examine the safety and tolerability of TLN-232 in patients with recurrent metastatic melanoma(Maximum 13 months from date of initial infusion of TLN-232 (Day 1, Cycle 1))
研究者
研究点 (4)
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