NCT01279603已完成1 期
A Phase 1, Multi-center, Open-label, Dose-escalation, Safety, Pharmacodynamic and Pharmacokinetic Study of GO-203-2c Given Intravenously Daily X21 Repeated Every 28 Days in Patients With Advanced Solid Tumors Including Lymphomas
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 23
- 试验地点
- 4
- 主要终点
- Number of Participants with Adverse Events as a Measure of Safety and Tolerability
研究概览
简要总结
This clinical trial is about testing GO-203-2c, which is a newly discovered compound that binds to an oncoprotein (a cancer causing protein) called MUC1 (which is over-expressed in many cancers). By binding to MUC1, GO-203-2c eventually causes tumor cell death in laboratory studies.
This study is being done to:
- Test the safety of GO-203-2c and see what effects (good and bad) it has on you and your cancer
- Find the highest dose of GO-203-2c that can be given without causing bad side effects
- Examine how much GO-203-2c 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 GO-203-2c on the size and activity of cancer in your 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
- •Histologically confirmed solid tumors or lymphomas
- •Tumor progression observed after receiving standard/approved systemic chemotherapy and/or immunotherapy including monoclonal antibodies, or when there is no approved or effective therapy
- •One or more measureable tumors by radiological evaluation
- •Karnofsky performance ≥ 70%
- •Life expectancy of ≥ 3 months
- •Age ≥ 18 years
- •Signed, written IRB-approved informed consent
- •Negative pregnancy test (if female)
- •Adequate liver function:
- •Bilirubin less than or equal to 1.5 x upper limit of normal (ULN)
- •AST (SGOT), ALT (SGPT) and Alkaline phosphatase less than or equal to 2.5 x ULN (if liver metastases are present, then less than or equal to 5 x ULN is allowed)
- •Adequate renal function:
- •Serum creatinine within normal limits, OR calculated creatinine clearance ≥ 60 mL/min/1.73 m2 for patients with serum creatinine above institutional ULN.
- •Corrected serum calcium ≥ lower limit of the institutional normal range (LLN)
- •Serum phosphorus level ≥ LLN
- •Adequate hematologic function:
- •Absolute Neutrophil Count ≥ 1500 cells/mm3
- •Platelet count ≥ 100,000 (cells/mm3)
- •Hemoglobin ≥ 9 g/dL
- •Urinalysis:
- •No clinically significant abnormalities
- •Adequate coagulation function:
- •PT ≤ 1.25 x ULN
- •PTT ≤ 1.25 x ULN
- •For men and women of child-producing potential, agreement to use 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 childbearing 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 that she is pregnant while participating in this study, she should inform her treating physician immediately.
- •Major surgery within 4 weeks prior to Day 1, or not fully recovered by Day 1
- •Minor surgery within 2 weeks prior to Day 1, or not fully recovered by Day 1
- •Treatment with radiation therapy within 4 weeks prior to Day
- •Received systemic chemotherapy or monoclonal antibody or other immunotherapy within 4 weeks prior to Day 1 (exceptions: 6 weeks for nitrosourea, mitomycin C, or any agent with a known treatment effect > 4 weeks' duration), or not fully recovered from any side effects from previous therapy by Day 1
- •History of allergic reactions attributed to excipients or chemical products used in the final GO-203-2c drug formulation
- •Known infection with HIV, hepatitis B, or hepatitis C.
- •Subjects with risk factors for gastrointestinal perforation or pulmonary hemorrhage (e.g. unresected luminal intestinal cancers; abdominal carcinomatosis within 3 months before the first dose of study drug, abdominal fistula, acute diverticulitis, peptic ulcer disease, irritable bowel syndrome, Crohn's disease, pulmonary hemorrhage, hemoptysis, or tuberculosis)
- •Currently receiving or having received treatment with any other investigational agent within 4 weeks prior to Day 1, or not fully recovered from toxicities of prior treatment by Day 1
- •Serious and/or poorly controlled non-malignant disease (including but not limited to, ongoing or active infection, hydronephrosis, hypertension, diabetes, or other conditions) that could compromise protocol objectives in the opinion of the Investigator and/or the sponsor. Patients with such conditions should be discussed with the Medical Monitor prior to enrollment. All medical conditions must be NCI CTCAE Grade 1 or lower at baseline.
- •Unwillingness or inability to comply with requirements of this protocol
研究组 & 干预措施
GO-203-2c
Experimental
干预措施: GO-203-2c (Drug)
结局指标
主要结局
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
时间窗: 24 months
To determine the maximum tolerated dose (MTD) and identify the dose limiting toxicities (DLT) of GO-203-2c - To establish the dose of GO-203-2c recommended for future phase II protocols
次要结局
未报告次要终点
研究者
研究点 (4)
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