NCT00452257已完成1 期
A Phase 1b Pharmacokinetic-Pharmacodynamic-Pharmacogenomic Study of Enzastaurin in Patients With B-Cell Chronic Lymphocytic Leukemia (B-CLL)
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
- 18
- 试验地点
- 1
- 主要终点
- To characterize the inhibitory effects of enzastaurin on the pGSK3 beta level in B-CLL cells.
研究概览
简要总结
The primary objective of this study is to see if enzastaurin affects the pGSK3 beta level in B-cell chronic lymphocytic leukemia (B-CLL) cells.
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
- •Patients are eligible to be included in the study only if they meet all of the following criteria:
- •Patients with B-cell CLL as diagnosed by expression of CD19, CD5, and CD23 by flow cytometry.
- •Rai Stage III or IV disease or earlier stage disease with indications for therapy per NCI Working Group criteria (Cheson et al. 1996)
- •Absolute lymphocyte count > or = to 5,000/microliter, with a lymphocyte WBC differential of > or = to 70%.
- •Platelet count >20,000/microliter.
- •Adequate organ function, including the following:
- •Hepatic: bilirubin < or = to 1.5 times the upper limit of normal (x ULN); alkaline phosphatase (ALP), aspartate transaminase (AST), and alanine transaminase (ALT) < or = to 2.5 x ULN
- •Renal: serum creatinine < or = to 1.5 X ULN.
排除标准
- •Patients will be excluded from the study if they meet any of the following criteria:
- •Are unable to swallow tablets.
- •Are unable to discontinue use of carbamazepine, phenobarbital, and phenytoin.
- •Are pregnant or breastfeeding.
- •Have central nervous system (CNS) metastases (unless the patient has completed successful local therapy for CNS metastases and has been off of corticosteroids for at least 4 weeks before starting study therapy).
- •Have a serious concomitant systemic disorder (including active bacterial, fungal, or viral infection) that, in the opinion of the investigator, would compromise the patient's ability to adhere to the protocol.
研究组 & 干预措施
A
Experimental
干预措施: enzastaurin (Drug)
结局指标
主要结局
To characterize the inhibitory effects of enzastaurin on the pGSK3 beta level in B-CLL cells.
时间窗: baseline, cycle 1, end of study
次要结局
- Evaluation of activity of PKC beta in B-CLL cells(baseline, end of study)
- Response rate(baseline to measured progressive disease)
- Duration of response(time of response to progressive disease)
- Time to progressive disease(baseline to measured progressive disease)
- Safety(every cycle)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
2 期
Evaluation of Enzastaurin in the Treatment of Persistent or Recurrent Ovarian or Primary Peritoneal CancerNeoplasmsCarcinomaOvarian CancerNCT00420381Eli Lilly and Company28
已完成
1 期
Study of the Selective PI3K-Beta Inhibitor GSK2636771 in Combination With Pembrolizumab in Patients With Metastatic Melanoma and PTEN LossMelanoma and Other Malignant Neoplasms of SkinMetastatic MelanomaNCT03131908M.D. Anderson Cancer Center28
已完成
1 期
Enzastaurin in Treating Young Patients With Refractory Primary CNS TumorsBrain and Central Nervous System TumorsNeuroblastomaNCT00503724Pediatric Brain Tumor Consortium32
已完成
1 期
A Phase I Trial of Enzastaurin (LY317615) in Combination With Carboplatin in Adults With Recurrent GliomasRecurrent GliomasNCT01445119Eli Lilly and Company58
已完成
2 期
Trial of Enzastaurin and Bevacizumab in Participants With Recurrent Malignant GliomasRecurrent GlioblastomaNCT00586508Eli Lilly and Company81