NL-OMON38217已完成不适用
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 - COEB071X2101
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- ovartis
- 入组人数
- 6
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •-Diffuse large B-cell lymphoma 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 or those with refractory disease may be considered for the study following a single regimen of chemotherapy such as R-CHOP or R-EPOCH. There is no limit to number of 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 study treatment as long as steroid treatment is tapered to a total daily dosage of 10mg or less of prednisone (or it*s equivalent) prior to AEB071 administration
排除标准
- •1. Patients at screening who are treated with strong inducers or inhibitors of cytochrome P450 3A4 (CYP3A4) that can not be discontinued
- •2. 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)
- •3. Patients with another malignancy that was treated within the last three years with the exceptions of localized basal cell carcinoma and cervical carcinoma
- •4. Patients with impairment of GI function or GI disease that could interfere with the absorption of AEB071
- •5. Patients with severe systemic infections, current or within the two weeks prior to initiation of AEB071
- •6. Patients with a known history of Human Immunodeficiency Virus (HIV) .
- •* HIV testing is not required as part of this study.
- •7. 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 PK half-life 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
- •8. Patients with any history of significant coagulopathy or a medical condition requiring long term systemic anticoagulation that would interfere with biopsies. Low-dose aspirin treatment (up to 200 mg/day) or anticoagulation therapy that can be interrupted to allow biopsies are allowed. (This exclusion criterion applies only to study subjects who consent to the optional pre- and post-dose tumor biopsies)
- •9. Patients with abnormal laboratory values, defined as one of the following:
- •a. Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 3 times upper limit of normal (ULN) combined with total bilirubin > 2 ULN
- •b. AST or ALT > 5 times ULN
- •c. Total bilirubin >2 ULN
- •d. Absolute neutrophil count (ANC) * 1.0 x 109/L (1000/mm3)
- •e. Platelets * 75 x 109/L (75,000/mm3)
- •f. Hemoglobin (Hgb) * 90 g/L (9 g/dL)
- •g. Abnormal coagulation profile including Prothombin (PT), activated Partial thromboplastin Time (PTT) and fibrinogen
- •10. Patients having undergone major surgery less than 4 weeks prior to enrollment or that have not fully recovered from prior surgery
- •13. 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
- •* Hepatitis B and C testing is not required as part of this study
研究者
相似试验
已完成
不适用
An open-label, single arm, Phase Ib/II study of AEB071 (a protein kinase C inhibitor) and everolimus (mTOR inhibitor) in patients with CD79-mutant or ABC subtype diffuse large B-cell lymphomaDiffuse Large B Cell Lymphomanon-Hodgkin lymphoma10025320NL-OMON40516ovartis4
进行中（未招募）
1 期
An Open-Label, Single-arm, Phase Ib/II study of AEB071 (a Protein Kinase C Inhibitor) and Everolimus (mTOR inhibitor) in Patients with CD79-mutant or ABC subtype Diffuse Large B-Cell LymphomaDiffuse Large B-cell Lymphoma (DLBCL)EUCTR2013-001265-16-FRovartis Pharma Services AG70
进行中（未招募）
1 期
An Open-Label, Single-arm, Phase Ib/II study of AEB071 (a Protein Kinase C Inhibitor) and Everolimus (mTOR inhibitor) in Patients with CD79-mutant or ABC subtype Diffuse Large B-Cell LymphomaDiffuse Large B-cell Lymphoma (DLBCL)EUCTR2013-001265-16-DEovartis Pharma Services AG70
进行中（未招募）
1 期
Ph Ib/II study of AEB071+everolimus in patients with diffuse large B-cell lymphomaDiffuse Large B-cell Lymphoma (DLBCL)EUCTR2013-001265-16-NLovartis Pharma Services AG70
进行中（未招募）
1 期
Study of safety and efficacy of AEB071 and everolimus in patients withCD79-mutant or ABC subtype Diffuse Large B-Cell Lymphoma (DLBCL)EUCTR2013-001265-16-ITovartis Farma S.p.A70