NCT01402440终止1 期
An Open-Label, Single-arm, Phase I Study of AEB071 (a Protein Kinase C Inhibitor) in Patients With CD79-mutant Diffuse Large B-Cell Lymphoma
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 15
- 试验地点
- 7
- 主要终点
- Frequency of Dose Limiting Toxicity (DLT) during cycle 1 (Dose Escalation phase)
研究概览
简要总结
This study has two phases, a dose escalation phase and a dose expansion phase. For dose escalation, the primary objective is to estimate the maximum tolerated dose of AEB071 in patients with diffuse large b-cell lymphoma. The endpoint for this objective will be occurrence of Dose Limiting Toxicity. For dose expansion, the primary objective is to characterize the safety and tolerability of the maximum tolerated dose or recommended phase 2 dose of AEB071 in patients with diffuse large b-cell lymphoma. The endpoints for this objective will be occurrence of Adverse Events (AEs), Serious Adverse Events (SAEs), assessment of clinical laboratory values, and vital sign measurements.
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
- •Diffuse large B-cell lymphoma (DLBCL) with activating mutations in CD79 (A or B subunits). DLBCL that arose from transformed indolent lymphoma is allowed.
- •Prior treatment and relapse following anthracycline-based chemotherapy and autologous bone marrow or stem cell transplant. Patients who are not transplant eligible may be considered for the study following a single regimen of chemotherapy such as R-CHOP or R-EPOCH alone. There is no limit to prior therapy allowed.
- •Patients may be treated with localized radiation to as many as two sites of disease, so long as measurable or evaluable disease remains at untreated sites.
- •Patients may be treated with corticosteriods immediately prior to enrollment and during the course of the study treatment as long as steriod treatment is tapered to a toal daily dosage of 10mg or less of prednisone (or it's equivalent) prior to AEB071 administration
- •WHO performance status of ≤2
排除标准
- •Patients at screening who are treated with strong inducers or inhibitors of cytochrome P450 3A4 (CYP3A4) that can not be discontinued.
- •Impaired cardiac function or clinically significant cardiac diseases, including any of the following:
- •History or presence of ventricular tachyarrhythmia
- •Presence of unstable atrial fibrillation (ventricular response > 100 bpm); Patients with stable atrial fibrillation are eligible, provided they do not meet any of the other cardiac exclusion criteria.
- •Angina pectoris or acute myocardial infarction ≤ 3 months prior to starting study drug
- •Other clinically significant heart disease (e.g., symptomatic congestive heart failure; uncontrolled arrhythmia or hypertension; history of labile hypertension or poor compliance with an antihypertensive regimen)
- •Patients with another malignancy that was treated within the last three years with the exceptions of localized basal cell carcinoma and cervical carcinoma.
- •Patients with impairment of GI function or GI disease that could interfere with the absorption of AEB
- •Patients with a known history of Human Immunodeficiency Virus (HIV)
- •HIV testing is not required as part of this study
- •Patients with a known history of active hepatitis B or C infection unless they are on antiviral therapy
- •The determination of active hepatitis status should be as per standard of care at each site
- •Hepatitis B and C testing is not required as part of this study
- •Time since the last prior therapy for treatment of underlying malignancy**:
- •Cytotoxic chemotherapy: ≤ than the duration of the most recent cycle of the previous regimen (with a minimum of 2 weeks for all)
- •Biologic therapy (e.g., antibodies): ≤ 4 weeks
- •≤ 5 x t1/2 of a small molecule therapeutic, not otherwise defined above
- •**Patients must have recovered or stabilized from all toxicities related to their previous treatment except for alopecia
- •Patients with any history of significant coagulopathy or a medical condition requiring long term systemic anticoagulation that would interfere with biopsies.
- •Patients having undergone major surgery less than 4 weeks prior to enrollment or that have not fully recovered from prior surgery.
- •Pregnant or nursing (lactating) women
- •Other protocol-defined inclusion/exclusion criteria may apply
研究组 & 干预措施
AEB071
Experimental
干预措施: AEB071 (Drug)
结局指标
主要结局
Frequency of Dose Limiting Toxicity (DLT) during cycle 1 (Dose Escalation phase)
时间窗: Cycle 1 (28 days)
Number of Pparticipants reporting Serious Adverse Events and Adverse Events (Dose Expansion phase)
时间窗: Baseline, 28 days
次要结局
- Overall Response Rate, using NHLIWG criteria(Baseline, 12 months)
- Number of Participants reporting Serious Adverse Events and Adverse Events(Baseline, 12 months)
- AEB071 PK parameters including Cmax, tmax, AUCt, Ctrough, CL/F and RA(First 7 months of treatment period)
- Pre and post-dose gene and protein expression of cytokines and any correlations with exposure to AEB071(First 7 months of treatment period)
研究者
研究点 (7)
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