Phase I Study of Farnesyl Transferase Inhibitor BMS-214662 (NSC 710086D) in Solid Tumors
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- MTD, defined as the dose level among the 9 levels studied having toxicity rate closest to a target of 33%, graded according to CTC version 2.0
研究概览
简要总结
Phase I trial to study the effectiveness of BMS-214662 in treating patients who have solid tumors. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die
详细描述
OBJECTIVES:
I. Determine the maximum tolerated dose of BMS-214662 in patients with solid tumors.
II. Evaluate intermediate biological endpoints as surrogates for the effectiveness of this drug in these patients.
III. Determine the nature of dose limiting toxicity of this drug in this patient population.
IV. Determine the recommended phase II regimen of this drug in these patients. V. Establish a pharmacologic and pharmacokinetic profile of this drug in 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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of malignant solid tumor for which a standard curative therapy does not exist
- •Performance status - Karnofsky 70-100%
- •At least 6 months
- •WBC at least 3,000/mm^3
- •Absolute neutrophil count at least 1,500/mm^3
- •Platelet count at least 100,000/mm^3
- •Hemoglobin at least 10.0 g/dL
- •Bilirubin no greater than 2.0 mg/dL
- •AST no greater than 2 times upper limit of normal
- •Albumin at least 3.0 g/dL
- •Creatinine no greater than 1.5 mg/dL
- •No uncontrolled heart disease
- •No history of clinically significant cardiac arrhythmia that could be exacerbated by QT interval prolongation
- •Corrected QT interval no greater than 450 milliseconds
- •Must not require total parenteral nutrition
- •No manifestations of malabsorption syndrome due to prior surgery, gastrointestinal disease, or unknown reasons
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •No signs or symptoms of acute infection requiring systemic therapy
- •No grade 3 or 4 neurotoxicity from prior anticancer treatment or neuropathy from any cause
- •No confusion, disorientation, or psychiatric illness that may preclude study
- •No more than 3 prior chemotherapy regimens
- •At least 4 weeks since prior chemotherapy (6 weeks since prior nitrosoureas or mitomycin) and recovered
- •No other concurrent antineoplastic agents
- •No concurrent hormonal anticancer therapy
- •At least 4 weeks since prior radiotherapy
- •No concurrent radiotherapy
- •Prior drugs known to prolong the QT interval allowed if they can be safely discontinued for a time period equal to 4 elimination half-lives prior to administering study drug
- •No drugs known to prolong the QT interval during and for 24 hours after study drug
- •No concurrent therapy with known CYP3A4 substrates
- •No other concurrent investigational agents
排除标准
- 未提供
研究组 & 干预措施
Treatment
Patients receive BMS-214662 IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 6 weeks in the absence of disease progression or unacceptable toxicity.
干预措施: BMS-214662 (Drug)
Treatment
Patients receive BMS-214662 IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 6 weeks in the absence of disease progression or unacceptable toxicity.
干预措施: laboratory biomarker analysis (Other)
结局指标
主要结局
MTD, defined as the dose level among the 9 levels studied having toxicity rate closest to a target of 33%, graded according to CTC version 2.0
时间窗: Up to 6 weeks
Toxicity is defined as grade 3, 4 non-hematologic and grade 4 hematologic (neutropenia and thrombocytopenia) toxicity. The continual reassessment method (CRM) will be used.
次要结局
未报告次要终点