NCT00372736已完成1 期
A Phase I Study of AEG35156 Given as a 2 Hour Intravenous Infusion in Combination With Docetaxel in Patients With Solid Tumours
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 27
- 试验地点
- 3
- 主要终点
- Maximum tolerated dose of AEG35156 in combination with docetaxel
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. AEG35156 may help docetaxel work better by making tumor cells more sensitive to the drug.
PURPOSE: This phase I trial is studying the side effects and best dose of AEG35156 when given together with docetaxel in treating patients with locally advanced, metastatic, or recurrent solid tumors.
详细描述
OBJECTIVES:
Primary
- Determine the maximum tolerated dose and define a recommended phase II dose of AEG35156 in combination with docetaxel in patients with locally advanced, metastatic, or recurrent solid tumors.
Secondary
- Determine the qualitative and quantitative toxicities of AEG35156 in combination with docetaxel given and define the duration and reversibility of those toxicities.
- Determine the pharmacokinetic profile of this regimen.
- Assess, preliminarily, the antitumor activity of this regimen in these patients.
- Assess the pharmacodynamic effects of AEG35156 on X-linked inhibitor of apoptosis levels and apoptosis in peripheral blood mononuclear cells and in tumor tissue of these patients.
- Evaluate M30/M65 cytokeratin 18 level (a marker of apoptosis/necrosis of epithelial tumors) in serum of these patients.
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:
- •Histologically confirmed solid tumor
- •Locally advanced, metastatic, or recurrent disease that is refractory to standard curative therapy or for which no curative therapy exists
- •Clinically and/or radiologically documented disease
- •Treatment with single-agent docetaxel is a reasonable treatment option
- •No newly diagnosed CNS metastases
- •Previously treated and stable (≥ 6 months) intracranial disease allowed
- •PATIENT CHARACTERISTICS:
- •ECOG performance status 0-2
- •Life expectancy ≥ 12 weeks
- •Absolute granulocyte count ≥ 1,500/mm³
- •Platelet count ≥ 100,000/mm³
- •PT or INR and PTT normal
- •Creatinine normal
- •Bilirubin normal
- •AST and ALT ≤ 1.5 times upper limit of normal (ULN)
- •Gamma-glutamyl transferase ≤ 3 times ULN
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •No underlying serious illness or medical condition that might be aggravated by treatment or might interfere with study treatment, including, but not limited to, the following:
- •Serious uncontrolled infection
- •Significant cardiac dysfunction
- •Significant neurological disorder that would impair the ability to obtain informed consent
- •No known bleeding disorders
- •No prior serious allergic reaction to taxane (paclitaxel or docetaxel)
- •No pre-existing peripheral neuropathy ≥ grade 2
- •PRIOR CONCURRENT THERAPY:
- •More than 4 weeks since prior chemotherapy and recovered
- •At least 2 weeks since prior hormonal therapy or immunotherapy
- •At least 4 weeks since prior external-beam radiotherapy to < 30% of marrow-bearing areas
- •Low-dose, nonmyelosuppressive radiotherapy allowed
- •At least 2 weeks since prior surgery and recovered
- •More than 4 weeks since prior investigational agents or new anticancer therapy
- •No prior nephrectomy
- •No other concurrent chemotherapy
- •No concurrent radiotherapy
- •Small-volume, non-myelosuppressive palliative radiotherapy allowed
- •No other concurrent experimental drugs or anticancer therapy
- •No concurrent therapeutic dose anticoagulant therapy
- •Non-therapeutic dose anticoagulant therapy (i.e., 1 mg daily oral warfarin) allowed
排除标准
- 未提供
结局指标
主要结局
Maximum tolerated dose of AEG35156 in combination with docetaxel
时间窗: 2-3 years
Doses of AEG35156 escalated as shown in protocol section 4.3 in patient cohorts given a fixed dose of docetaxel. MTD defined as that dose level at which ≥ 2/6 patients experienced DLT (as defined in protocol section 4.6)
Recommended phase II dose
时间窗: 2-3 years
RPTD for AEG35156 defined as one dose lower than MTD
次要结局
- Pharmacokinetic profile(Each cycle)
- Toxicities(Every 3 weeks)
- M30/M65 cytokeratin 18 level(Each cycle)
- Antitumor activity(Every 6 weeks)
- Pharmacodynamic effects of AEG35156 on X-linked inhibitor of apoptosis levels and apoptosis in peripheral blood mononuclear cells and tumor tissue(Each cycle)
研究者
研究点 (3)
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