NCT00730262终止2 期
A Phase II Study of TLN-4601 in Patients With Glioblastoma Multiforme
Thallion Pharmaceuticals8 个研究点 分布在 2 个国家目标入组 40 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
- 40
- 试验地点
- 8
- 主要终点
- To assess the efficacy of TLN-4601 in patients with recurrent glioblastoma multiforme (GBM) as measured by 6-month progression free survival from date of initial infusion of TLN-4601 (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-4601 used to treat patients with Glioblastoma Multiforme(GBM) that recur/progress after receiving first line systemic therapy post surgery/radiotherapy.
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 Glioblastoma Multiforme (GBM)
- •Prior treatment with radiation and one first line systemic therapy (including temozolomide or other chemotherapy, immunotherapy, targeted therapy or combination therapies), followed by measurable and unequivocal evidence of tumor progression or recurrence
- •Age ≥ 18 years
- •Normal organ and marrow function as defined below:
- •leukocytes ≥3 x 109/L
- •absolute neutrophil count ≥1.5 x 109/L
- •platelets ≥100 x 109/L
- •hemoglobin ≥90 g/L
- •total bilirubin ≤2.5 X institutional upper limit of normal
- •AST(SGOT)/ALT(SGPT) ≤2.5 X institutional upper limit of normal
- •creatinine ≤1.0 X institutional upper limit of normal
排除标准
- •Patients with a life expectancy < 12 weeks
- •Patients with a documented history of HIV, active hepatitis B or C infections
- •Female patients who are pregnant or lactating
- •Patients in whom a proper central line (Portacath-like device) cannot be established
- •Patients with a known hypersensitivity to farnesylated dibenzodiazepinone or polysorbate 80
- •Patients with uncontrolled hypotension
- •Patients with concomitant therapy of therapeutic coumadin
研究组 & 干预措施
Single-Arm
Experimental
干预措施: TLN-4601 (Drug)
结局指标
主要结局
To assess the efficacy of TLN-4601 in patients with recurrent glioblastoma multiforme (GBM) as measured by 6-month progression free survival from date of initial infusion of TLN-4601 (Day 1, Cycle 1).
时间窗: 6-month progression free survival from date of initial infusion of TLN-4601 (Day 1, Cycle 1)
次要结局
- To examine the safety and tolerability of TLN-4601 in patients with recurrent GBM(Maximum 13 months from date of initial infusion of TLN-4601 (Day 1, Cycle 1))
研究者
研究点 (8)
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