NCT00722488已完成1 期
An Open-Label, Dose Escalation, Phase I Study of MLN4924, a Novel Inhibitor of Nedd8 Activating Enzyme, in Adult Patients With Lymphoma or Multiple Myeloma
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 56
- 试验地点
- 2
- 主要终点
- Evaluation of safety and tolerability
研究概览
简要总结
This is an open-label, multicenter, phase 1, dose escalation study of MLN4924 in adult patients with lymphoma or multiple myeloma. The patient population will consist of adults with a confirmed diagnosis of lymphoma (Waldenstrom's macroglobulinemia is permitted) or multiple myeloma that is relapsed and/or refractory after at least 2 prior standard chemotherapeutic regimens and for which no curative option exists.
Patients in the expansion cohort, Schedule E, must specifically have Hodgkin lymphoma, DLBCL-GCB subtype, DLBCL-non-GCB subtype, or Mantle Cell Lymphoma (MCL). Patients with multiple myeloma will no longer be evaluated as a part of this study.
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
- •Eastern Cooperative Oncology Group (ECOG) performance status 0-
- •Patients must have a confirmed diagnosis of lymphoma (Waldenstrom's macroglobulinemia is permitted) or multiple myeloma that is relapsed and/or refractory after at least 2 prior standard chemotherapeutic regimens and for which no curative option exists.
- •As of Protocol Amendment 7, patients in the expansion cohort, Schedule E, must specifically have Hodgkin lymphoma, DLBCL-GCB subtype, DLBCL-non-GCB subtype, or Mantle Cell Lymphoma (MCL). Patients with multiple myeloma will no longer be evaluated as a part of this study.
- •Tumor that is evaluable by radiography, serum or urine electrophoresis (for patients with multiple myeloma), or clinical evaluations.
- •As of Protocol Amendment 7, tumor that is evaluable by radiography or clinical evaluations.
- •Suitable venous access for the conduct of blood sampling for MLN4924
- •Adequate Organ Function
排除标准
- •Systemic antineoplastic therapy within 21 days preceding first dose of study treatment, or rituximab therapy within 2 months preceding first dose of study treatment (unless there was evidence of PD since their last dose of rituximab).
- •Treatment with corticosteroids within 7 days preceding first dose of study treatment.
- •Prior treatment with radiation therapy involving >25% of bone marrow; Any radiotherapy within 14 days before first dose of study treatment.
- •Treatment with CYP3A inducers within 14 days before the first dose of MLN
- •Moderate and strong CYP3A inhibitors and CYP3A inducers are not permitted during the study.
- •Patients requiring Coumadin who cannot be switched to a low molecular weight heparin should not be considered for this study.
- •Absolute neutrophil count less than 1,000/mm3; platelet count less than 75,000/mm
- •Calculated creatinine clearance less than or equal to 50 mL/minute.
研究组 & 干预措施
1
Experimental
MLN4924
干预措施: MLN4924 (Drug)
结局指标
主要结局
Evaluation of safety and tolerability
时间窗: 12 months (maximum duration of therapy)
次要结局
- Disease response(12 months (maximum duration of therapy))
研究者
研究点 (2)
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