NCT00900614已完成1 期
An Open-label Phase I Dose Escalating Study of APR-246 for Infusion in Patients With Refractory Hematologic Malignancies or Prostate Carcinoma
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 12
- 主要终点
- Dose-Limiting Toxicity (DLT) is reached and HFD is defined accordingly, OR the dose, which is expected to result in maximum plasma concentration close to, but not exceeding 35 μg/ml in any single patient without showing signs of DLT.
研究概览
简要总结
The purpose of this study is to determine the highest feasible dose (HFD) of intravenous (IV) APR-246 when given to patients with refractory hematologic malignancies or prostate carcinoma.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- •Male or female ≥ 18 years of age.
- •Any below mentioned advanced disease, which is not eligible for other therapies. The diagnosis should have been confirmed either histologically or cytologically:
- •Acute myeloid leukemia.
- •Acute lymphoid leukemia.
- •Chronic lymphocytic leukemia.
- •Chronic myeloid leukemia.
- •Chronic myelomonocytic leukemia.
- •Multiple myeloma.
- •Non Hodgkin's lymphoma.
- •Hodgkin's lymphoma.
- •Myelodysplastic syndrome.
- •Myelofibrosis.
- •Hormone refractory, metastatic prostate carcinoma.
排除标准
- 未提供
结局指标
主要结局
Dose-Limiting Toxicity (DLT) is reached and HFD is defined accordingly, OR the dose, which is expected to result in maximum plasma concentration close to, but not exceeding 35 μg/ml in any single patient without showing signs of DLT.
时间窗: 21 days
次要结局
- Determination of the toxicity and safety profile of APR-246 based on safety parameters from the entire study period.(continuously during 21 days)
- Determination of the PK profile for up to 22 hours after the last APR-246 infusion. Cmax (maximal plasma concentration), AUC (area under the curve), t1/2 (half-life) and clearance will be determined.(continuously, during 21 days)
研究者
研究点 (12)
Loading locations...
相似试验
已完成
1 期
Study of a c-Met Inhibitor PLB1001 in Patients With PTPRZ1-MET Fusion Gene Positive Recurrent High-grade GliomasGliomaNCT02978261Beijing Pearl Biotechnology Limited Liability Company18
终止
1 期
Phase I, Open-label, Dose Escalation of AZD4877 in Hematologic MalignanciesLymphomaNCT00460460AstraZeneca75
已完成
1 期
Safety Study of AP24534 to Treat Chronic Myelogenous Leukemia (CML) and Other Hematological MalignanciesHematologic MalignanciesChronic Myelogenous LeukemiaNCT00660920Ariad Pharmaceuticals81
已完成
1 期
Dose Escalation Study of MLN0128 in Relapsed or Refractory Multiple Myeloma or Waldenstrom MacroglobulinemiaRelapsed Multiple MyelomaRefractory Multiple MyelomaWaldenstrom MacroglobulinemiaNCT01118689Millennium Pharmaceuticals, Inc.39
终止
1 期
Safety and Tolerability Study of AZD7762 in Combination With GemcitabineSolid TumorsAdvanced Solid MalignanciesCancerNCT00937664AstraZeneca24