NCT01641250已完成1 期
Open Label, Multicenter, Dose Escalation Phase 1a/b Study of RO5429083, Administered as Intravenous Infusion Alone or in Combination With Cytarabine in Patients With Acute Myelogenous Leukemia (AML).
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
- 44
- 主要终点
- Safety: Incidence of adverse events (including maximum tolerated dose/optimal biological dose)
研究概览
简要总结
This multi-center, open-label study will evaluate the safety, pharmacokinetics, pharmacodynamics and efficacy of RO5429083 alone and in combination with cytarabine in patients with acute myelogenous leukemia. In Part A, patients will receive multiple escalating doses of RO5429083 intravenously. In Part B, patients will receive RO5429083 plus up to 4 cycles of cytarabine (1000 mg/m2 iv daily for 5 consecutive days). Anticipated time on study treatment is until disease progression or unacceptable toxicity occurs.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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
- •Adult patients, >/= 18 years of age
- •Histologically or cytologically confirmed, acute myelogenous leukemia (all subtypes except acute promyelotic leukemia) according to WHO criteria
- •Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2
- •All non-hematological adverse events of any prior chemotherapy, surgery, or radiotherapy must have resolved to NCI-CTC AE Grade < 2, except alopecia
- •Adequate hepatic and renal function
- •Patient must be willing to submit blood and bone marrow samples for PK and PD analyses and exploratory biomarkers
排除标准
- •Patients receiving any other investigational or commercial agents or therapies administered with the intention to treat their malignancy within 14 days of first receipt of study drug, with the exception of hydroxyurea
- •History of allergic reactions attributed to components of cytarabine and/or the formulated product
- •Current evidence of CNS leukemia
- •Increased QTc interval (QTc > 470 ms), baseline resting bradycardia < 45 beats per minute, or baseline resting tachycardia < 100 beats per minute
- •Family history of long QT syndrome or other risk factors for torsades de pointes, and/or the use of concomitant medications that prolong QT/QTc interval
- •Uncontrollable intercurrent illness
- •Pregnant or breast-feeding women
- •HIV-positive patients receiving anti-retroviral therapy
- •Patients who refuse to potentially receive blood products and/or have a hypersensitivity to blood products
研究组 & 干预措施
Part B: RO5429083 + cytarabine
Experimental
干预措施: cytarabine (Drug)
Part A: RO5429083
Experimental
干预措施: RO5429083 (Drug)
Part B: RO5429083 + cytarabine
Experimental
干预措施: RO5429083 (Drug)
结局指标
主要结局
Safety: Incidence of adverse events (including maximum tolerated dose/optimal biological dose)
时间窗: approximately 24 months
次要结局
- Pharmacokinetics of cytarabine in combination with RO5429083: Area under the concentration-time curve (AUC)(Pre-dose and up to 24 hrs post-dose, Cycles 1 and 3)
- Pharmacodynamics: Biomarker levels in blood/bone marrow(Pre-dose and up to 96 hrs post-dose)
- Clinical response according to hematologic malignancy assessments(approximately 24 months)
- Pharmacokinetics o RO5429083 alone and in combination with cytarabine: Area under the concentration-time curve (AUC)(Pre-dose and up to 96 hrs post-dose)
研究者
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