NCT00985868已完成1 期
A CCLG/Cancer Research UK Phase I Trial of AT9283 (a Selective Inhibitor of Aurora Kinases) Given for 72 Hours Every 21 Days Via Intravenous Infusion in Children and Adolescents With Relapsed and Refractory Solid Tumors
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 33
- 试验地点
- 5
- 主要终点
- Dose-limiting toxicities
研究概览
简要总结
RATIONALE: AT9283 may stop the growth of tumor 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 AT9283 in children and adolescents with relapsed and refractory solid tumors.
详细描述
OBJECTIVES:
Primary
- To evaluate the safety and tolerability of Aurora kinase inhibitor AT9283 by characterizing the dose-limiting toxicities in children and adolescents with relapsed and refractory solid tumors.
- To determine the maximum-tolerated dose of this regimen in these patients.
Secondary
- To determine the pharmacokinetic parameters of this regimen in these patients.
- To demonstrate the pharmacodynamic (PD) activity of this regimen in these patients by studying its effects in surrogate tissue.
- To assess preliminary evidence of activity of this regimen by using appropriate objective tumor measurements 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
- 2 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed solid tumor meeting 1 of the following criteria:
- •Refractory to conventional treatment
- •Disease for which no conventional therapy exists
- •Patients with CNS tumors must be on a stable or decreasing dose of dexamethasone for ≥ 1 week before study entry
- •PATIENT CHARACTERISTICS:
- •WHO performance status (PS) 0-2 OR Lansky Play PS 70-100% (> 50% is acceptable if it is due to a stable neurological deficit or CNS tumor)
- •Life expectancy ≥ 12 weeks
- •ANC ≥ 1,000/mm^3
- •Platelet count ≥ 100,000/mm^3
- •Hemoglobin ≥ 9.0 g/dL
- •Serum bilirubin < 1.5 times upper limit of normal (ULN)
- •Creatinine kinase normal
- •ALT or AST < 2.5 times ULN (≤ 5 times ULN if due to tumor)
- •Creatinine clearance/EDTA-measured GFR ≥ 60 mL/min
- •Sufficient blood volume to undergo the blood-sampling regimen specified by the protocol that, in the opinion of the investigator, will not jeopardize patient's safety
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use 2 methods of effective contraception 4 weeks before, during, and for 6 months after completion of study therapy
- •Not at high medical risk because of non-malignant systemic disease, including active uncontrolled infection
- •Not known to be serologically positive for hepatitis B or C or HIV
- •Fractional shortening of > 29% on echocardiogram
- •LVEF ≥ 50%
- •No history of allergy or auto-immune disease
- •No congenital heart disease
- •No other condition that, in the investigator's opinion, would not make the patient a good candidate for the clinical trial
- •PRIOR CONCURRENT THERAPY:
- •See Disease Characteristics
- •Recovered from prior therapy
- •More than 4 weeks since prior radiotherapy (except for palliative reasons), endocrine therapy, immunotherapy, or chemotherapy (6 weeks for investigational medicinal products, 2 weeks for vincristine)
- •More than 3 months since prior autologous stem cell transplantation
- •No prior allogenic bone marrow transplantation
- •No prior extensive radiotherapy to > 25% of bone marrow
- •No prior Aurora kinase inhibitor
- •No prior major thoracic or abdominal surgery from which the patient has not yet recovered
- •No prior or concurrent participation in another interventional clinical trial
- •Participation in an observational study allowed
- •No other concurrent anticancer therapy or investigational drugs
排除标准
- 未提供
结局指标
主要结局
Dose-limiting toxicities
Maximum-tolerated dose
次要结局
- The magnitude and duration of biomarkers (M30 and M65 ELISA) change after AT9283 administration
- Pharmacokinetic parameters and the correlation between them and toxicity and/or efficacy
- Objective tumor response according to RECIST criteria
研究者
研究点 (5)
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