A Phase I Study of EC0489 Administered Weeks 1 and 3 of a 4-Week Cycle
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 65
- 试验地点
- 12
- 主要终点
- Maximum tolerated dose (MTD)
研究概览
简要总结
This is a Phase 1 clinical trial evaluating the safety and tolerability of escalating doses of EC0489 in patients with refractory or metastatic tumors who have exhausted standard therapeutic options.
详细描述
This is a Phase 1, dose escalation study of EC0489 administered by intravenous bolus (IV) during weeks 1 and 3 of a 4-week cycle in PART A and weekly on a 4-week cycle in PART B.
Both Parts are open to patients with refractory or metastatic cancer who have exhausted standard therapeutic options. EC0489 is a drug that is specifically designed to enter cells via a folate vitamin receptor. Experimental evidence shows that the target receptor is over-expressed in many human cancers. There are no previous human studies of EC0489; however, lab research (research in test tubes or animals) using EC0489 has shown activity against tumors in animals. This activity in animal models suggests that EC0489 may be useful as chemotherapy against human cancers. The primary objective of this study is to determine the safety and maximum tolerated dose of EC0489 given by intravenous bolus. The efficacy of treatment will also be measured.
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
- •18 years of age or older
- •Histological or cytological diagnosis of neoplasm
- •No effective standard therapeutic options
- •ECOG performance status of 0-2
- •≥ 4 weeks post therapeutic radiation or recovered (or returned to baseline) from any acute toxicity associated with prior cytotoxic therapy. Patients previously treated with non-cytotoxic therapy (e.g., EGFR, VGEF, etc.) and who have recovered from or have controlled drug-associated toxicity are allowed to enter the trial after a period consisting of 4 half-lives of the agent.
- •Negative serum pregnancy test for women of child-bearing potential within one week prior to treatment with investigational agents (99mTc-EC20 and EC0489)and willingness to practice contraceptive methods
- •Adequate bone marrow reserve, renal and hepatic function
排除标准
- •Concurrent malignancies
- •Women who are pregnant or breast-feeding
- •Evidence of symptomatic brain metastases
- •Receiving concomitant anticancer therapy (excluding supportive care)
- •Requires palliative radiotherapy at time of study entry
- •Requires antifolate therapy for comorbid conditions
- •Heart failure characterized as greater than NYHA Class I
- •History of myocardial infarct
- •Any of the following baseline echocardiogram findings: valvular lesions (stenosis or insufficiency) characterized as greater than moderate, systolic ventricular impairment characterized as greater than mild, left ventricular ejection fraction < 55%, any feature of the echocardiogram that would confound interpretation of the serial echocardiograms required by the protocol
结局指标
主要结局
Maximum tolerated dose (MTD)
时间窗: Dose escalation to the highest dose that can be safely administered to produce acceptable, manageable and reversible toxicity in no more than 0 or 1 of 6 patients
次要结局
- Pharmacokinetic and pharmacodynamic parameters(Obtained during the first cycle of therapy on Days 1 and 3)
- Anti-tumor activity(Initial dose of study therapy to disease progression)
- Uptake of 99mTc-EC20 in tumors and normal tissues(1-2 hours post administration of 99mTc-EC20)
- Safety and Tolerability(Initiation of study therapy through 30 day post last dose of study therapy)