NCT00949559已完成1 期
A Phase 1, Multi-center, Open-label, Dose-escalation, Safety, Pharmacodynamic and Pharmacokinetic Study of EP-100 Given Intravenously 3 Out of 4 Weeks in Subjects With Advanced Solid Tumors
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 38
- 试验地点
- 4
- 主要终点
- To determine the maximum tolerated dose (MTD) and the dose limiting toxicities (DLT) of EP-100
研究概览
简要总结
This study is being done to:
- Test the safety of EP-100 and see what effect (good and bad) it has on the patient and their cancer;
- Find the highest dose of EP-100 that can be given without causing bad side effects;
- Examine how much EP-100 is in the blood at certain times after it is given and how quickly the body gets rid of it;
- Observe whether there is any effect of EP-100 on the size and activity of cancer in the patient's body.
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
- •Subjects with histologically confirmed solid carcinomas
- •Subjects whose tumors over express LHRH receptors in tumor biopsies
- •Tumor progression after receiving standard/approved chemotherapy or where there is no approved therapy
- •One or more metastatic tumors measurable on CT scan or evaluable disease
- •Karnofsky performance ≥ 70%
- •Life expectancy of at least 3 months
- •Age greater than or equal to 18 years
- •Signed, written informed consent. Consent must be provided prior to performing any study-related procedures.
- •A negative pregnancy test (if female)
- •Acceptable liver function
- •Acceptable renal function
- •Serum creatinine within normal limits, OR calculated creatinine clearance greater than or equal to 60 mL/min/1.73 m2 for subjects with creatinine levels above institutional normal.
- •Acceptable hematologic status:
- •No clinically significant abnormalities
- •Acceptable coagulation status:
- •For men and women of child-producing potential, the use of effective contraceptive methods during the study
排除标准
- •New York Heart Association Class III or IV, cardiac disease, myocardial infarction within the past 6 months, unstable arrhythmia, or evidence of ischemia on ECG
- •Active, uncontrolled bacterial, viral, or fungal infections, requiring systemic therapy
- •Pregnant or nursing women. NOTE: Women of child bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; or abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
- •Treatment with radiation therapy or investigational therapy within 4 weeks prior to Day
- •Had received chemotherapy prior to study entry equivalent within 3 to 5 half-lives of that chemotherapy agent or 4 weeks prior to study entry (whichever is shorter) with resolution of any side effects from that previous therapy (6 weeks for nitrosoureas or Mitomycin C).
- •Subjects with active CNS metastases are excluded.
- •Subjects with a history of CNS metastases will be eligible if they have been treated and are stable without symptoms for 4 weeks after completion of treatment, with image documentation required, and must be off steroids.
- •Had major surgery, other than diagnostic surgery, within 4 weeks prior to Day 1
- •Had minor surgery within 2 weeks prior to Day 1
- •Patients who may benefit from hormonal treatment such as breast cancer patients whose tumors are hormone receptor positive (ER/PR) and without rapidly progressive visceral disease or patients with prostate cancer who have not had hormonal manipulation therapy.
- •Patients who have potentially life-threatening disease (hypercalcemia, spinal cord compression) whose disease may acutely progress if EP-100 administration causes a flare reaction.
- •Unwillingness or inability to comply with procedures required in this protocol
- •Known infection with HIV, hepatitis B, or hepatitis C
- •Subjects who are susceptible to histamine release (e.g. patients with mastocytosis, mastocytoma, mast cell leukemia, asthma, hay fever, and other allergic disorders and disorders that increase mast cell numbers).
- •Patients under chronic treatment with corticosteroids.
- •Baseline QTc exceeding 450 msec (using the Bazetts formula) and/or patients receiving class 1A or class III antiarrythmic agents.
- •Serious nonmalignant disease (e.g., hydronephrosis, liver failure, or other conditions) that could compromise protocol objectives in the opinion of the investigator and/or the sponsor
- •Subjects who are currently receiving any other investigational agent
- •Subjects should not be using any LHRH agonists (such as leuprolide [Lupron, Eligard], buserelin [Suprefact, Suprecor], nafarelin [Synarel], histrelin [Supprelin], goserelin [Zoladex], deslorelin [Suprelorin, Ovuplant], Triptorelin and others) or antagonists (such as Abarelix [Plenaxis], Cetrorelix [Cetrotide], Ganirelix [Antagon] and others) prior to study treatments. If LHRH agonists are being used, a 4-week washout period is recommended.
结局指标
主要结局
To determine the maximum tolerated dose (MTD) and the dose limiting toxicities (DLT) of EP-100
时间窗: weekly
To establish the dose of EP-100 recommended for future phase II protocols
时间窗: weekly
次要结局
未报告次要终点
研究者
研究点 (4)
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