A Phase 1, First-in-Human Study Evaluating the Safety, Tolerability, and Pharmacokinetics of CPI-300 Via Intravenous Infusion in Patients With Advanced Solid Tumors
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 17
- 试验地点
- 4
- 主要终点
- Adverse Events
研究概览
简要总结
This is a prospective, open-label, single arm, non-randomized study of CPI-300 in patients with advanced tumors. CPI-300 is administered via intravenous infusion using an accelerated titration method followed by a conventional 3 + 3 study design to identify the maximum tolerated dose (MTD).
详细描述
Up to 6 dose levels of CPI-300 will be tested. MTD will be defined as the dose associated with a dose limiting toxicity (DLT) in less than or equal to 33% of patients at the dose level tested. Dose limiting toxicity (DLT) is defined as one of the following events occurring from the intravenous injection of CPI-300 within 28 days:
- Grade 4 or greater treatment related adverse events
- Any Grade 3 or greater treatment related non-hematologic, non-dermatologic toxicity (including nausea, vomiting or diarrhea lasting more than 72 hours)
Blood samples will be drawn to determine drug blood concentrations for pharmacokinetic assessment.
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
- •Have a histologically or cytologically confirmed diagnosis of advanced solid tumor
- •Have advanced or metastatic disease refractory to standard curative or palliative therapy or contraindication to standard therapy
- •Have an ECOG performance status of 0-1
- •Have adequate bone marrow reserve, liver and renal function
- •Be reasonably recovered from preceding major surgery or no major surgery within 4 weeks prior to the start of Day 1 treatment
- •Have a negative pregnancy test for females with child bearing age at screening and should not be breast feeding
- •Be willing to abstain from sexual activity or practice physical barrier contraception from study entry to 6 months after the last day of treatment
排除标准
- •Have peripheral neuropathy of Grade 3 or Grade 4 at screening
- •Have peripheral sensory neuropathy of Grade 2 or greater at screening
- •Have an interval from previous neurotoxic drugs less than 3 months unless reasonably recovered from all grades of neurotoxicity to grade 1 or lower as judged by the investigator
- •Have known hypersensitivity to chemotherapeutic agents
- •Have chronic diarrhea
- •Have a history of thrombocytopenia with complications including hemorrhage or bleeding > Grade 2 that required medical intervention or any hemolytic condition or coagulation disorders that would make participation unsafe
- •Have unresolved toxicity from previous treatment or previous investigational agents; excluding alopecia
- •Received investigational agents or systemic anticancer agents (other than neurotoxic compounds) within 5 half lives or 28 days, whichever is shorter, prior to Day 1 of treatment
- •Have signs or symptoms of end organ failure, major chronic illnesses other than cancer, or any severe concomitant conditions
- •Have experienced any of the following within the 6-month period prior to screening: angina pectoris, coronary artery disease or cerebrovascular accident, transient ischemic attack, cardiac failure with known ejection fraction less than 40%, or cardiac arrhythmia requiring medical therapy
- •Have other severe acute or chronic medical or psychiatric conditions or laboratory abnormality that would make the patient inappropriate for enrollment in this study
- •Is pregnant or breast-feeding
研究组 & 干预措施
CPI-300
Dose Escalation Group: CPI-300 will be administered via intravenous infusion once every 2 weeks for up to 6 dose levels using an accelerated titration method followed by a conventional 3 + 3 study design
干预措施: CPI-300 (Drug)
结局指标
主要结局
Adverse Events
时间窗: 28 days
To determine the maximum tolerated dose (MTD), which is defined as the highest dose level at which number of patients reporting a dose limiting toxicity (DLT) is less than or equal to 33%
次要结局
- Adverse Effect(28 Days and additional CPI-300 treatment till disease progression or intolerability)
- Clinical Benefit(28 Days and additional CPI-300 treatments till disease progression or intolerability)
- Maximum Plasma Concentration (Cmax)(8 Days)
- Area Under the Curve (AUC)(8 Days)