NCT00875745已完成1 期
Phase I, Open-label, Dose-escalation Study of the Combination of Sorafenib and Vorinostat in Poor-risk Acute Myelogenous Leukemia (AML) and High Risk Myelodysplastic Syndrome (MDS)
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
- 15
- 试验地点
- 1
- 主要终点
- Determine the maximum tolerated dose of a combination of Sorafenib and Vorinostat administered to patients with poor-risk AML, or MDS with >10% blasts.
研究概览
简要总结
The purpose of this study is to test the safety of sorafenib and vorinostat when given together to see what effects (good and bad) it has on the patient and their acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS). This study is also being done to find the highest dose of sorafenib and vorinostat that can be given together without causing severe side effects.
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
- •Patients must have a diagnosis of AML (> 20% myeloid blasts in the peripheral blood or bone marrow) or MDS with > 10% myeloid blasts in the bone marrow. Patients with Acute Promyelocytic Leukemia (APL) must be refractory to all-trans retinoic acid (ATRA) and arsenic trioxide.
- •The patients must have one of the following criteria:
- •Age of 18 to 69 years; relapsed or refractory disease following at least one prior therapeutic regimen; not a candidate for cytotoxic or other conventional therapies due to disease refractoriness, poor performance status, or co-morbidities
- •Age of 70 years or older; received no previous therapies (other than hematopoietic growth factors or hydroxyurea); not a candidate for cytotoxic or other conventional therapies due to poor performance status, co-morbidities, or personal preference
- •Age of 70 years or older with relapsed or refractory disease
- •The patient must have discontinued all previous therapies for acute leukemia for at least 14 days and recovered from the acute effects of the therapy.
- •Patients must have an ECOG (Zubrod) performance status of 0-2
- •Patients must be able to take and tolerate oral medications
- •Patients must have adequate organ function as specified in the protocol.
- •Patients not on anti-coagulation must have an INR < 1.5 and a PTT within normal limits.
排除标准
- •Pregnant women or nursing mothers are not eligible for this trial.
- •Patients may receive no other concurrent biologic therapy, cytotoxic chemotherapy or radiation therapy during this trial.
- •Patients with one or more serious preexisting medical conditions that, in the opinion of the investigator, would preclude participation in this study. See protocol for listing.
- •Patients with known central nervous system (CNS) leukemia by spinal fluid cytology, flow cytometry or imaging
- •Patients with previous autologous or allogeneic stem cell transplantation who have current side effects and/or complications that in the opinion of the investigator can interfere with the interpretation of the toxicities.
研究组 & 干预措施
Sorafenib-Vorinostat
Experimental
This is a single-arm, non-randomized feasibility and safety Phase I trial of a combination of Sorafenib and Vorinostat, both administered orally.
干预措施: Sorafenib-Vorinostat (Drug)
结局指标
主要结局
Determine the maximum tolerated dose of a combination of Sorafenib and Vorinostat administered to patients with poor-risk AML, or MDS with >10% blasts.
时间窗: Baseline through cycle 3
次要结局
- Evaluate response and the duration of response to this combination targeted therapy(Baseline through Cycle 3)
- Evaluate the toxicity of the combination of Sorafenib and Vorinostat in patients receiving this therapy(Baseline through Cycle 3)
研究者
研究点 (1)
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