NCT01863485已完成1 期
Phase 1 Safety, Tolerability, and Pharmacokinetic Study of CM082 (X-82) Tablets in Advanced Cancer Patients in China
AnewPharma3 个研究点 分布在 1 个国家目标入组 44 人开始时间: 2013年5月最近更新:
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
- 入组人数
- 44
- 试验地点
- 3
- 主要终点
- Maximum Tolerated Dose
研究概览
简要总结
This is a Phase I Dose-Escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of CM082 tablets in Chinese Patients With Advanced Solid Tumors.
详细描述
This is a Phase I Dose-Escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of CM082 tablets in Chinese Patients With Advanced Solid Tumors. After the maximum tolerated dose (MTD) or the optimal biological dose is identified, an expansion cohort of ~20 advanced renal cell carcinoma patients will be enrolled to further characterize the safety and tumor response by CT.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically or cytologically confirmed diagnosis of advanced solid tumor malignancy that is not responsive to standard therapies or for which there is no effective therapy.
- •Eastern Cooperative Group (ECOG) Performance Status score of 0 or
- •Life expectancy of at least 12 weeks.
- •No immuno deficiency.
- •Adequate organ system function, defined as follows:
- •Absolute neutrophil count (ANC) ≥1.5 x 10**9/L
- •Platelets ≥100 x 10**9/L
- •Hemoglobin ≥10 g/dL
- •Total bilirubin ≤1.5 times the upper limit of normal (ULN)
- •Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤1.5x the upper limit of normal (ULN) if no liver involvement or ≤2.5x the upper limit of normal with liver involvement.
- •Creatinine ≤ 1.5 x ULN.
- •At least 4 weeks or 5 half-life after receiving cancer therapy (i.e., chemotherapy, radiation therapy, immunotherapy, biologic therapy, hormonal therapy, surgery and/or tumor embolization.
- •Willingness and ability to comply with trial and follow-up procedures.
- •Ability to understand the nature of this trial and give written informed consent.
排除标准
- •Not recovered from prior anti-cancer therapy or surgery.
- •Have taken strong cytochrome P450 3A4 inhibitors or inducers in the last 2 weeks.
- •Concomitant use of drugs with a risk of causing prolonged corrected QT interval and/or Torsades de Pointes.
- •Patients with a history of intolerance to, or significant toxicity with, VEGFR tyrosine kinase inhibitor(s) (TKI).
- •Females who are pregnant or breastfeeding.
- •Those in reproductive ages who refuse to use contraception.
- •Those with concurrent condition(e.g. psychological, neuronal, cardiovascular, respiratory conditions or infections) that in the investigator's opinion would jeopardize compliance with the protocol.
- •Patients with known central nervous system (CNS) metastases.
- •Presence of active gastrointestinal (GI) disease or other condition that will interfere significantly with the absorption, distribution, metabolism, or excretion of CM082 (X-82).
- •Patients with known GI disorders such as vomiting, diarrhea.
- •Patients who are hepatitis B virus positive.
- •Drug abuser.
研究组 & 干预措施
CM082
Experimental
CM082 tablet
干预措施: CM082 Tablet (Drug)
结局指标
主要结局
Maximum Tolerated Dose
时间窗: 12 months
To determine the Maximum Tolerated Dose in Chinese patients with advanced solid tumors.
次要结局
未报告次要终点
研究者
研究点 (3)
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