NCT00046735已完成1 期
A Single-Center, Open-Label, Between-Patient, Dose-Escalation Phase 1 Study of CDC-501 In Patients With Solid Tumors
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Celgene
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- To identify the MTD and safety of CDC-501 when given in a 6-wk cycle of daily administration of CDC-501 for 4 wks followed by a 2-wk rest in doses of 5 mg/day up to 25 mg/day in pts with solid tumors that are refractory after standard treatment.
研究概览
简要总结
To identify the maximum tolerated dose (MTD) and safety of CDC-501 when given in a 6-week cycle in patients with solid tumors that are refractory after standard treatment.
详细描述
Identify the maximum tolerated dose (MTD) and safety of CDC-501 when given in a 6-week cycle in patients with solid tumors that are refractory after standard treatment
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
- •Patient must understand and voluntarily sign an informed consent document.
- •Age 18 years at the time of signing Informed Consent
- •Histologically or cytologically documented solid tumors that are refractory to standard/conventional therapy or for which no standard/conventional therapy exists.
- •Patients must have at least one measurable or non-measurable lesion according to the RECIST Criteria (Appendix I).
- •Patient has an ECOG (Zubrod) performance status of ≤
- •Approximate life expectancy greater than 3 months.
- •Laboratory tests within these ranges:
- •Absolute neutrophil count ≥ 1,500/μlL
- •Platelet count ≥100,000/μL
- •Serum creatinine ≤1.5 mg/dL
- •Total bilirubin ≤1.5 mg/dL
- •AST (SGOT)/ALT(SGPT) ≤ 2 x upper limit of normal (ULN) or ≤ 5 x ULN if hepatic metastases present
- •The following prior treatments are allowable under this protocol:
- •Radiation, if discontinued at least 4 weeks prior to treatment under this protocol Chemotherapy, if discontinued at least 4 weeks prior to treatment under this protocol, and at least 6 weeks prior to treatment under this protocol for prior nitrosurea or mitomycin-C treatment
- •Hormonal therapy for cancer, if discontinued at least 4 weeks prior to treatment under this protocol
- •Other investigational drugs, if discontinued at least 4 weeks prior to treatment under this protocol
- •Surgery, if minor surgery occurred at least 2 weeks prior to treatment under this protocol, or at least 4 weeks since major surgery
- •Patient must be able to adhere to the study visit schedule and other protocol requirements.
- •Women of childbearing potential (WCBP) must have a negative serum or urine pregnancy test within 7 days prior to baseline. In addition, sexually active WCBP must agree to use adequate contraceptive methods (oral, injectable, or implantable hormonal contraceptive; tubal ligation; intra-uterine device; barrier contraceptive with spermicide; or vasectomized partner).
- •Exclusion Criteria
- •Myocardial infarction within the previous 6 months, unstable angina,symptomatic congestive heart failure, or other significant uncontrolled cardiac arrhythmia.
- •Cerebrovascular accident or transient ischemic attack, pulmonary embolism, deep vein thrombosis or other significant thromboembolic event in the previous 6 months.
- •Active infection, including known human immunodeficiency virus (HIV) positivity or acquired-immunodeficiency-syndrome (AIDS)-related illness.
- •CNS metastases, unless controlled by previous radiation and the patient is neurologically stable.
- •Any serious medical condition, laboratory abnormality or psychiatric illness that would prevent the patient from signing the informed consent or limit survival to less than 3 months.
- •Pregnant or nursing females.Female patients of childbearing potential who are unwilling to use reliable contraceptive methods.
- •Any condition, including the presence of laboratory abnormalities, which in the opinion of the Investigator places the patient at unacceptable risk if he/she were to participate in the study.
排除标准
- 未提供
研究组 & 干预措施
1
Experimental
干预措施: Lenalidomide (Drug)
结局指标
主要结局
To identify the MTD and safety of CDC-501 when given in a 6-wk cycle of daily administration of CDC-501 for 4 wks followed by a 2-wk rest in doses of 5 mg/day up to 25 mg/day in pts with solid tumors that are refractory after standard treatment.
时间窗: 6-week cycle comprising daily administration of CDC-501 for 4 weeks followed by a 2-week rest
次要结局
未报告次要终点
研究者
研究点 (1)
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