NCT00606879终止1 期
A Phase I, Multi-Center, Open Label, Dose Escalation, Safety, PK and PkD Study of Orally Administered SGX523, a Small Molecule Anti-Cancer Agent, on a Twice Daily, Uninterrupted Schedule in Patients With Advanced Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 46
- 试验地点
- 2
- 主要终点
- Maximum Tolerated Dose
研究概览
简要总结
SGX523 is a drug which acts by blocking the function of an enzyme called MET. MET activity may be important in growth and survival of some types of cancer. This Phase I trial is studying the safety, side effects, and best dose of SGX523 when given to patients with advanced cancer, and how well it inhibits MET activity in tumors.
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
- •Subject has the ability to understand, able, willing to comply with study procedures and follow up visits, and has provided written consent
- •Pathologic evidence of solid tumor
- •Failed standard therapy and deemed by the Investigator to be suitable for participation into the trial
- •Laboratory values (obtained within 10 days prior to enrollment): ANC: >= 1.5 × 109/L; Platelets: >= 100 × 109/L; Hemoglobin: >= 10.0 g/dL (without transfusions); Bilirubin: within normal range; AST, ALT, and alkaline phosphatase: <= 2.5 x ULN without tumor liver involvement; Serum creatinine: within normal limits; Calculated creatinine clearance: >= 60 mL/min/1.73 m2 for patients with creatinine > Institutional Normal Values; PT/PTT/INR: within normal limits..
- •Have IHC evidence of phospho-MET expression on tumor material no more than 12 months old. This is a requirement only for entry into the MTD dose expansion phase.
- •Have no residual toxic effects of previous therapy, and undergo a washout period of at least 5 half-lives from the time of administration of the previous therapy.
排除标准
- •Pregnant, lactating, or may become pregnant
- •Cardiac disease requiring medical therapy
- •Have had a major surgery within 4 weeks prior to Day 1 of the study
- •Have an active, uncontrolled bacterial, viral, or fungal infection that requires ongoing systemic therapy
- •Have a known active infection with HIV, hepatitis B or C
- •Have psychiatric or seizure disorders that would require therapy or interfere with study participation
- •Have other severe concurrent nonmalignant disease that could compromise protocol objectives, including malabsorptive conditions
- •Patients receiving prohibited medications as listed in Appendix E, including drugs categorized as strong inhibitors of CYP3A4 and A5 and drugs known to have a high potential risk of liver toxicity
- •Have known allergy to SGX523 formulation or its excipients (croscarmellose sodium, lactose monohydrate and magnesium steareate)
- •Patients receiving anti-coagulant therapy
研究组 & 干预措施
Single arm
Experimental
干预措施: SGX523 Capsules (Drug)
结局指标
主要结局
Maximum Tolerated Dose
时间窗: Within first 28 Days
次要结局
- PK parameters: Cmin, Cmax, AUC∞, AUCtau, T1/2, Tmax, Vd, CLpo(To 28 Days after patient withdrawal)
研究者
研究点 (2)
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