NCT00248521Unknown1 期
A Cancer Research UK Phase I Trial to Evaluate the Safety, Tolerability and Pharmacokinetics of 17-Dimethylaminoethyl-amino-17-Demethoxygeldanamycin (17-DMAG) Given as a Once Weekly Infusion in Patients With Advanced Solid Tumors
Institute of Cancer Research, United Kingdom6 个研究点 分布在 1 个国家目标入组 35 人开始时间: 2005年10月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 35
- 试验地点
- 6
- 主要终点
- Recommended phase II dose of 17-dimethylaminoethylamino-17-demethoxygeldanamycin (17-DMAG) at 28 days after treatment
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as 17-dimethylaminoethylamino-17-demethoxygeldanamycin (17-DMAG), work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.
PURPOSE: This phase I trial is studying the side effects and best dose of 17-DMAG in treating patients with metastatic solid tumors or tumors that cannot be removed by surgery.
详细描述
OBJECTIVES:
Primary
- Determine the maximum tolerated dose, dose-limiting toxicity, and recommended phase II dose of 17-dimethylaminoethylamino-17-demethoxygeldanamycin (17-DMAG) in patients with unresectable or metastatic solid tumors.
- Determine the feasibility, safety, and toxicity profile of this drug in these patients.
Secondary
- Determine the clinical pharmacokinetic profile of this drug in these patients.
- Determine tumor response in patients treated with this drug.
- Determine the biologically effective dose.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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 or cytologically confirmed solid tumor
- •Unresectable or metastatic disease
- •Standard curative or palliative measures do not exist OR are no longer effective OR patient refused such measures
- •No known brain metastases
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status
- •Life expectancy
- •More than 12 weeks
- •Hematopoietic
- •Absolute neutrophil count > 1,500/mm^3
- •Platelet count ≥ 100,000/mm^3
- •Hemoglobin ≥ 9.0 g/dL
- •Bilirubin normal
- •ALT and AST ≤ 1.5 times upper limit of normal
- •No chronic liver disease
- •Hepatitis B or C negative
- •Creatinine normal OR
- •Creatinine clearance normal
- •Cardiovascular
- •No symptomatic New York Heart Association class III-IV cardiac disease
- •No myocardial infarction within the past year
- •No active ischemic heart disease within the past year
- •No poorly controlled angina
- •No uncontrolled dysrhythmia or dysrhythmias requiring antiarrhythmic drugs
- •No transient ischemic attack
- •No stroke
- •No peripheral vascular disease
- •No congenital long QT syndrome
- •No history of serious ventricular arrhythmia (ventricular tachycardia or ventricular fibrillation ≥ 3 beats in a row)
- •QTc < 450 msec (for men) and 470 msec (for woman)
- •LVEF > 40% by MUGA
- •No left bundle branch block
- •No symptomatic pulmonary disease requiring medication, including any of the following:
- •Dyspnea with or without exertion
- •Paroxysmal nocturnal dyspnea
- •Oxygen requirement
- •Significant pulmonary disease (e.g., chronic obstructive/restrictive pulmonary disease
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception 4 weeks before, during, and for 6 months after completion of study treatment
- •No known HIV positivity
- •No other malignancy within the past 5 years except adequately treated cone biopsied carcinoma in situ of the cervix or basal cell or squamous cell skin cancer
- •No ongoing or active infection
- •No diabetes mellitus (with evidence of severe peripheral vascular disease or ulcers)
- •No psychiatric illness or social situation that would preclude study compliance
- •No other uncontrolled illness
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- 另有 17 项未显示
排除标准
- 未提供
结局指标
主要结局
Recommended phase II dose of 17-dimethylaminoethylamino-17-demethoxygeldanamycin (17-DMAG) at 28 days after treatment
次要结局
- Heat shock protein 90 (HSP90) client protein and co-chaperone changes up to 29 days after treatment
- Tumor response by RECIST criteria every 6 weeks while on study
- Clinical pharmacokinetic profile established during the first course of treatment
研究者
研究点 (6)
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