NCT00073944已完成1 期
Phase I Pharmacology Study Of Oral And Intravenous BCX-1777 In Patients With Refractory T-Cell And Non-T-Cell Malignancies
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 试验地点
- 1
研究概览
简要总结
RATIONALE: BCX-1777 may stop the growth of cancer cells by blocking the enzymes necessary for their growth.
PURPOSE: Phase I trial to study the effectiveness of BCX-1777 in treating patients who have refractory cancer.
详细描述
OBJECTIVES:
Primary
- Determine the maximum tolerated dose of BCX-1777 in patients with refractory T-cell or non-T-cell malignancies.
- Determine the safety and dose-limiting toxicity of this drug in these patients.
Secondary
- Determine the pharmacokinetics of single oral and single and multiple IV doses of this drug in these patients.
- Determine the oral bioavailability of this drug in these patients.
- Determine, preliminarily, the antitumor activity of this drug in these patients.
研究设计
- 研究类型
- Interventional
- 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
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed diagnosis of 1 of the following:
- •Hematologic malignancy that is refractory to at least 1 prior curative treatment
- •Non-hematologic tumor that is refractory to at least 2 prior therapies, with or without measurable disease, including the following:
- •Gastrointestinal adenocarcinoma of 1 of the following sites:
- •Pancreatic
- •Colorectal
- •Esophageal
- •Ovarian cancer
- •Astrocytoma brain tumor
- •Not immediately eligible for any other treatment that would be potentially curative or life-prolonging, in the opinion of the investigator
- •Patients who may be candidates for future bone marrow transplantation are eligible
- •No brain metastases (other than astrocytomas)
- •No clinically significant pleural effusion
- •No complete tumor obstruction (e.g., bronchus, ureter, or bowel)
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status
- •ECOG 0-2 OR
- •Karnofsky 50-100%
- •Life expectancy
- •Not specified
- •Hematopoietic
- •WBC at least 3,500/mm^3
- •Absolute neutrophil count at least 1,500/mm^3
- •Platelet count greater than 50,000/mm^3
- •Hematocrit stable without the need for transfusion (epoetin alfa support allowed)
- •Bilirubin less than 1.5 times upper limit of normal (ULN) (unless due to Gilbert's syndrome)
- •SGOT and SGPT less than 2 times ULN
- •No active hepatitis B or C
- •Creatinine clearance at least 50 mL/min
- •Cardiovascular
- •No American Heart Association class III or IV cardiac disease
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •HIV negative
- •No active systemic infection requiring IV antibiotics
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •Not specified
- •Chemotherapy
- •Not specified
- •Endocrine therapy
- •Concurrent corticosteroids allowed provided the patient is on a stable regimen
- •Radiotherapy
- •Not specified
- •Not specified
- •Recovered from prior therapy
- •No grade 2-4 toxicity
- 另有 2 项未显示
排除标准
- 未提供
研究者
研究点 (1)
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