NCT01991184已完成1 期
An Open-Label, Phase I, Dose-Escalation Study Evaluating The Safety And Tolerability Of Gdc-0853 In Patients With Relapsed Or Refractory B-Cell Non-Hodgkin's Lymphoma And Chronic Lymphocytic Leukemia
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
- 24
- 试验地点
- 10
- 主要终点
- Safety: Incidence of dose-limiting toxicities (DLTs) of GDC-0853
研究概览
简要总结
This open-label, Phase I study will evaluate the safety, tolerability, and pharmacokinetics of increasing doses of GDC-0853 in patients with relapsed or refractory B-cell non-Hodgkin's lymphoma or chronic lymphocytic leukemia. In a dose-expansion part, GDC-0853 will be assessed in subsets of patients.
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
- •Age >/= 18 years
- •ECOG score of 0-1
- •One of the following histologically-documented hematologic malignancies for which no effective standard therapy exists: indolent non Hodgkin's lymphoma (NHL), follicular lymphoma (FL), diffuse large B-cell lymphoma (DLBCL), mantle cell lymphoma (MCL), or chronic lymphocytic leukemia (CLL)
- •At least one site of disease that, as seen on CT scan, is > 1.5 cm in the greatest transverse diameter or > 1.0 cm in short axis diameter (except for patients with CLL)
- •An available tumor specimen
- •Adequate hematologic and organ function
- •For female patients of childbearing potential and male patients with partners of childbearing potential, use of effective contraceptive(s) as defined by protocol for the duration of the study
排除标准
- •Life expectancy < 12 weeks
- •< 3 weeks since the last anti-tumor therapy, including chemotherapy, biologic, experimental, hormonal or radiotherapy (with the exception of leuprolide or similar medications for prostate cancer)
- •Recent major surgical procedure or traumatic injury, or unhealed incisions or wounds
- •Active infection requiring IV antibiotics
- •Clinically significant history of liver disease, including viral or other hepatitis, current alcohol abuse, or cirrhosis.
- •Primary CNS malignancy or untreated/active CNS metastases (progressing or requiring anticonvulsants or corticosteroids for symptomatic control)
- •History of other malignancy within 5 years prior to screening, except for appropriately treated carcinoma in situ of the cervix, non-melanoma skin cancer, Stage I uterine cancer, or other cancers with a similar outcome
- •Cardiovascular dysfunction, including ventricular dysrhythmias or risk factors for ventricular dysrhythmias
- •Pregnancy, or lactation
- •Any other diseases that contraindicates the use of an investigational drug or that may affect the interpretation of the results or render the patient at high risk from treatment complications
研究组 & 干预措施
Dose-escalation
Experimental
干预措施: GDC-0853 (Drug)
结局指标
主要结局
Safety: Incidence of dose-limiting toxicities (DLTs) of GDC-0853
时间窗: Approximately 1 year
Safety: Maximum tolerated dose (MTD) of GDC-0853
时间窗: Approximately 1 year
次要结局
- Safety: Incidence of adverse events(Approximately 2 years)
- Pharmacokinetics: Maximum concentration (Cmax) of GDC-0853(35 days)
- Objective response to GDC-0853(Approximately 2 years)
- Pharmacokinetics: Area under the concentration-time curve (AUC) of GDC-0853(35 days)
- Progression-free survival(Approximately 2 years)
研究者
研究点 (10)
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