NCT00646139已完成1 期
A Combined Rising Single-Dose (RSD) and Rising Multiple-Dose (RMD) Phase 1 Study to Evaluate Safety, Tolerability and Pharmacokinetics of KX2-391 in Patients With Advanced Malignancies That Are Refractory to Conventional Therapies
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 7
- 试验地点
- 1
- 主要终点
- Maximum tolerated dose
研究概览
简要总结
RATIONALE: KX2-391 may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.
PURPOSE: This phase I trial is studying the side effects and best dose of KX2-391 in treating patients with advanced solid tumors or lymphoma that did not respond to treatment.
详细描述
OBJECTIVES:
Primary
- To define the maximum tolerated dose of KX2-391 when administered as multiple oral solutions in patients with refractory advanced solid tumors and lymphoma.
Secondary
- To determine the safety and tolerability of KX2-391 given as single and multiple oral solutions in these patients.
- To characterize the pharmacokinetic profile of single dosing and multiple dosing of KX2-391 in these patients.
- To determine the biological effects of KX2-391.
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
- •DISEASE CHARACTERISTICS:
- •Confirmed diagnosis of advanced solid tumor or lymphoma
- •Metastatic or unresectable disease
- •Standard curative or palliative measures do not exist or are no longer effective
- •Patients with treated brain or ocular metastases are eligible
- •PATIENT CHARACTERISTICS:
- •ECOG performance status 0-2
- •Life expectancy ≥ 14 weeks
- •ANC ≥ 1,500/mm³
- •Platelet count ≥ 100,000/mm³
- •Hemoglobin ≥ 10 g/dL
- •Serum bilirubin ≤ 2.5 times upper limit of normal (ULN)
- •ALT and AST ≤ 2.5 times ULN
- •Alkaline phosphatase ≤ 2.5 times ULN
- •Serum creatinine ≤ 1.5 times ULN or creatinine clearance > 60 mL/min
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective barrier contraception for 1 month prior to, during, and for 6 months after completion of study treatment
- •No inflammatory bowel disease, malabsorption syndrome, or other medical condition that may interfere with oral drug absorption
- •No signs or symptoms of end organ failure, major chronic illnesses other than cancer, or any severe concomitant conditions including, but not limited to, active infections that, in the opinion of the investigator, precludes protocol participation or compliance
- •No history of any of the following within the past 6 months:
- •Angina pectoris
- •Coronary artery disease
- •Hypertension
- •Cerebral vascular accident
- •Transient ischemic attack uncontrolled by medical therapy
- •No history of confirmed cardiac conduction abnormalities or arrhythmias
- •No known history of hepatitis B or C, or HIV infection
- •No known history of coagulation disorders or hemolytic conditions (e.g., sickle cell anemia)
- •PRIOR CONCURRENT THERAPY:
- •Recovered from all prior therapy
- •No prior major surgery to the upper gastrointestinal tract
- •More than 2 weeks since prior investigational agents or systemic anticancer agents (28 days for agents with unknown elimination half-lives or known elimination half-lives > 50 hours)
- •More than 4 weeks since prior radiotherapy to the sternum, pelvis, scapulae, vertebrae, or skull and recovered
- •More than 4 weeks since prior major surgery
- •More than 1 week since prior palliative low-dose radiotherapy to the limbs and recovered
- •More than 2 weeks since prior and no concurrent hormones (e.g., estrogen contraceptives, hormone replacement, anti-estrogen, or progesterone) or antiplatelet agents
- •More than 2 weeks since prior and no concurrent anticoagulants (e.g., coumadin) except prophylactic doses of anticoagulants for indwelling venous catheters
- •More than 2 weeks or 5 half-lives since prior and no concurrent cytochrome P450 modulators (e.g., strong inducers or inhibitors)
排除标准
- 未提供
结局指标
主要结局
Maximum tolerated dose
次要结局
- Safety
- Pharmacokinetics
- Biological effects
研究者
研究点 (1)
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