Study of EC0489 for the Treatment of Refractory or Metastatic Tumors
A Phase I Study of EC0489 Administered Weeks 1 and 3 of a 4-Week Cycle
研究概览
详细说明
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.
研究类型
注册 (实际的)
阶段
- 阶段1
联系人和位置
学习地点
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Indiana
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Lafayette、Indiana、美国、47905
- Horizon Oncology Center
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Maryland
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Baltimore、Maryland、美国、21201
- Greenebaum Cancer Center - University of Maryland
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Bethesda、Maryland、美国、20817
- Center for Cancer and Blood Disorders
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Michigan
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Detroit、Michigan、美国、48201
- Barbara Ann Karmanos Cancer Institute - Wayne State University
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Lansing、Michigan、美国、48910
- Great Lakes Cancer Institute - Michigan State University
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Southfield、Michigan、美国、48075
- Providence Cancer Institute
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
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最大耐受剂量 (MTD)
大体时间：剂量递增至可安全给药的最高剂量，以在 6 名患者中不超过 0 名或 1 名产生可接受、可控和可逆的毒性
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剂量递增至可安全给药的最高剂量，以在 6 名患者中不超过 0 名或 1 名产生可接受、可控和可逆的毒性
|
次要结果测量
结果测量 |
大体时间 |
|---|---|
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药代动力学和药效学参数
大体时间：在第 1 天和第 3 天的第一个治疗周期中获得
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在第 1 天和第 3 天的第一个治疗周期中获得
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抗肿瘤活性
大体时间：研究治疗的初始剂量至疾病进展
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研究治疗的初始剂量至疾病进展
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Uptake of 99mTc-EC20 in tumors and normal tissues
大体时间：1-2 hours post administration of 99mTc-EC20
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1-2 hours post administration of 99mTc-EC20
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Safety and Tolerability
大体时间：Initiation of study therapy through 30 day post last dose of study therapy
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Initiation of study therapy through 30 day post last dose of study therapy
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合作者和调查者
赞助
调查人员
- 研究主任：Richard A Messmann, MD, MHS, MSc、Endocyte
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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