NCT00391521已完成1 期
A Phase I Multicenter, Open-Label, Dose Escalation Trial of AS703569 Given Orally to Subjects With Solid Tumours
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- EMD Serono
- 入组人数
- 104
- 试验地点
- 1
- 主要终点
- Number and proportion of subjects experiencing: at least a Dose-Limiting Toxicity (DLT) in each cohort during the first cycle.
研究概览
简要总结
This is a Phase I trial. Some specific protocol information is proprietary and is not publicly available at this time. Full information will be provided to trial participants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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
- •Histopathologically confirmed locally advanced or metastatic solid tumour that is either refractory after standard of care therapy for the disease or for which standard of care therapy is not reliably effective or has a cancer for which no standard therapy exists
- •Age greater than or equal to 18 years
- •Has read and understands the informed consent form and is willing and able to give informed consent, and subject authorization under Health Insurance Portability and Accountability Act (HIPAA). Fully understands requirements of the study and willing to comply with all study visits and assessments
- •Subjects and their partners must be willing to avoid pregnancy during the study and until 1 month after the last study drug administration. Males with female partners of childbearing potential and female subjects of childbearing potential must therefore be willing to use adequate contraception such as, intra uterine device, diaphragm, or condom, for the duration of the study. For the purposes of this study, childbearing potential is defined as: "All female subjects unless they are post- menopausal for at least two years, are surgically sterile or sexually inactive"
- •Negative serum pregnancy test at the screening visit for women of childbearing potential
排除标准
- •Bone marrow impairment as evidenced by Hb < 9.0 g/dl, ANC < 1.5x 109/L, platelets < 75 x 109/L. Subjects may be transfused.
- •Renal impairment as evidenced by serum creatinine > 1.5 x ULN (upper limit of normal), and/or calculated creatinine clearance < 60 ml/min
- •Liver function abnormality as defined by total bilirubin > 1.5 ULN, or AST or ALT > 2.5x ULN at screening; for subjects with liver involvement AST or ALT > 5x ULN at screening
- •INR (blood coagulation) > 1.5 x ULN for subjects not on therapeutic doses of coumadin
- •History of CNS metastases, unless subject has been previously treated for CNS metastases, is stable by CT scan without evidence of cerebral edema, and has no requirements for corticosteroids or anticonvulsants
- •History of difficulty swallowing, malabsorption or other chronic gastro- intestinal disease or conditions that may hamper compliance and/or absorption of the tested product
- •Eastern Cooperative Oncology Group Performance Status (ECOG PS) > 2
- •Known HIV, hepatitis C, or hepatitis B positivity
- •Has received chemotherapy, immunotherapy, hormonal therapy, biologic therapy, or any other anticancer therapy or surgical intervention within 28 Days of Day 1 of study drug treatment (6 weeks for nitrosureas or mitomycin C), and must have fully recovered
- •Has received extensive prior radiotherapy on more than 30% of bone marrow reserves, or prior bone marrow/stem cell transplantation
- •Has received any investigational agent within 28 days of Day 1
- •Has history of any other significant medical disease or intervention including major gastric or small bowel surgery or has a psychiatric condition that might impair the subjects well-being or preclude full participation in the study
- •Is a pregnant or nursing female
研究组 & 干预措施
3
Active Comparator
Regimen 3
干预措施: AS703569 (Drug)
2
Active Comparator
Regimen 2
干预措施: AS703569 (Drug)
1
Active Comparator
Regimen 1
干预措施: AS703569 (Drug)
结局指标
主要结局
Number and proportion of subjects experiencing: at least a Dose-Limiting Toxicity (DLT) in each cohort during the first cycle.
次要结局
- Plasma and urine PK parameters of AS703569, genetic markers and potential markers of clinical and biological response.
- Number and proportion of subjects with Progressive Disease as assessed at the end of every other cycle.
研究者
研究点 (1)
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