Pharmacokinetic (PK) Study of Homoharringtonine (Omacetaxine Mepesuccinate) Administered Subcutaneously to Patients With Advanced Solid and Hematologic Tumors
2014年5月9日 更新者:ChemGenex Pharmaceuticals
A Pharmacokinetic Study of Homoharringtonine (Omacetaxine Mepesuccinate) Administered Subcutaneously to Patients With Advanced Solid and Hematologic Tumors
PK Study of Homoharringtonine (Omacetaxine Mepesuccinate) Administered Subcutaneously to Patients With Advanced Solid and Hematologic Tumors
研究概览
详细说明
This is an open-label non-randomized pharmacokinetic (PK) study of Homoharringtonine (Omacetaxine Mepesuccinate) administered as a subcutaneous (SC)injection to patients with relapsed and/or refractory hematologic malignancies and to patients with advanced solid tumors with no bone marrow involvement.
研究类型
介入性
注册 (实际的)
12
阶段
- 阶段1
联系人和位置
本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。
学习地点
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Texas
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Dallas、Texas、美国、75201
- Mary Crowley Cancer Research Center
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参与标准
研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- Be ≥18 years old.
Be diagnosed with relapsed or refractory leukemia including chronic myelogenous leukemia (CML), acute promyelocytic leukemia (APL), acute myelogenous leukemia (AML), or myelodysplastic syndrome (MDS)
- Relapsed defined as reappearance of leukemic blasts in the peripheral blood or the finding of ≥5% blasts in the bone marrow, not attributable to another cause (e.g., bone marrow regeneration after consolidation therapy).
- Refractory defined as no response to previous combined chemotherapy regimens including at least one cytarabine plus one anthracycline advanced solid tumors (i.e., breast, lung, head / neck, colorectal, melanoma, and sarcoma). Patients must have exhausted or become intolerant to all available therapies.
- (Patients with hematologic malignancies): Have completed all previous anti-leukemic therapy (except leukapheresis) at least 2 weeks prior to the first planned dose of OMA and must have fully recovered from side effects of a previous therapy unless, disease progression necessitates early therapy. Leukapheresis is allowed up to 24 hours prior to registration.
- (Patients with solid tumors): Patients may have measurable or unmeasurable disease. Measurable disease is defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as ≥20 mm with conventional computerized tomography (CT) or magnetic resonance imaging (MRI) scans, or as ≥10 mm with spiral computerized tomography (CT) scan. Imaging must be performed within 28 days of the first dose of study drug.
- Have an estimated life expectancy of ≥12 weeks
- Have an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of ≤2 (see Appendix B)
- Be able to provide written informed consent prior to enrollment into the study. In the event that the patient is re-screened for study participation or a protocol amendment alters the care of an ongoing patient, a new informed consent form must be signed.
- Be male or a non-pregnant, non-lactating female. Fertile patients must agree to use an effective barrier method contraception (e.g., latex condom, diaphragm, or cervical cap) to avoid pregnancy while on therapy and for 6 months following the discontinuation of the study drug.
A non-fertile female is defined as:
- Postmenopausal (amenorrheic for ≥12 months) Undergone a complete oophorectomy or hysterectomy.
- Have a negative serum pregnancy test within 7 days prior to the first dose of study drug (if patient is a female of childbearing potential).
- QTc <450 ms on screening 12-lead ECG (using Bazett's correction of QT interval formula [QTcB]).
- Have adequate organ function as indicated by the following laboratory values obtained within 7 days prior to the first dose of study drug as outlined in Table 3.
- Be able and willing to comply with the requirements of the entire study.
Exclusion Criteria:
- Received previous treatment with OMA within 6 months of study entry.
- Have New York Heart Association (NYHA) Class 3 or 4 heart disease, active ischemia, or any uncontrolled, unstable cardiac condition for which treatment for the condition is indicated but is not controlled despite adequate therapy, including angina pectoris, cardiac arrhythmia, hypertension, or congestive heart failure (see Appendix D).
- Experienced a myocardial infarction in the previous 12 weeks.
- Have solid tumors with known bone marrow or central nervous system (CNS) involvement.
- Have an active, uncontrolled systemic infection considered opportunistic, life threatening, or clinically significant at the time of treatment.
- Are pregnant or lactating.
- Received systemic chemotherapy in the 4 weeks prior to first dose of study drug, unless treatment is required for progressive leukemia. In patients with rapidly proliferating disease, hydroxyurea may be administered immediately prior to and during the first two cycles of treatment, if clinically indicated, to control disease.
- Received radiation therapy within 6 weeks of the first dose of study drug. Localized radiation for palliation may be administered with 2 weeks of the first dose of study drug.
- Have any medical condition or psychiatric disorder(s) rendering the patient unable to understand the nature, scope, and possible consequences of the study.
学习计划
本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。
研究是如何设计的?
设计细节
- 分配:不适用
- 介入模型:单组作业
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的:Homoharringtonine
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1.25 mg/m2 subcutaneous twice daily for 14 days
其他名称:
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研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
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Pharmacokinetic Evaluation
大体时间:28 days
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28 days
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员:John Nemunaitis, M.D.、Mary Crowley Cancer Research Center
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2008年4月1日
初级完成 (实际的)
2008年9月1日
研究完成 (实际的)
2009年1月1日
研究注册日期
首次提交
2008年5月7日
首先提交符合 QC 标准的
2008年5月8日
首次发布 (估计)
2008年5月9日
研究记录更新
最后更新发布 (估计)
2014年5月12日
上次提交的符合 QC 标准的更新
2014年5月9日
最后验证
2014年5月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.
Omacetaxine的临床试验
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Teva Branded Pharmaceutical Products R&D, Inc.完全的
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Teva Branded Pharmaceutical Products R&D, Inc.Cephalon; ChemGenex Pharmaceuticals完全的慢性粒细胞白血病美国, 加拿大, 法国, 德国, 匈牙利, 印度, 意大利, 波兰, 新加坡, 英国
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Teva Branded Pharmaceutical Products R&D, Inc.终止慢性粒细胞白血病美国, 比利时, 法国, 大韩民国
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Teva Branded Pharmaceutical Products R&D, Inc.Cephalon; ChemGenex Pharmaceuticals完全的慢性粒细胞白血病美国, 加拿大, 法国, 德国, 匈牙利, 印度, 意大利, 波兰, 新加坡, 英国
-
National Cancer Institute (NCI)完全的
-
ChemGenex Pharmaceuticals终止
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M.D. Anderson Cancer Center招聘中造血和淋巴细胞肿瘤 | 复发性急性髓性白血病 | 复发性骨髓增生异常综合征 | 难治性急性髓性白血病 | 难治性骨髓增生异常综合征 | 复发性急性双表型白血病 | 难治性急性双表型白血病美国
-
National Cancer Institute (NCI)完全的
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University of Illinois at ChicagoTeva Pharmaceuticals USA终止