NCT00085878已完成1 期
A Phase I, Dose Escalation Study to Assess the Safety and Pharmacokinetics of SB- 485232 Administered as Daily Subcutaneous Injections in Adult Patients With 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
- 25
- 试验地点
- 5
- 主要终点
- - Safety and tolerability endpoints will include evaluation of adverse events and changes in laboratory values and clinical variables from pre-dose values.
研究概览
简要总结
This is a phase I, open-label, dose-escalation study of SB-485232. Subjects will receive SB-485232 administered as subcutaneous injections daily for 14 days. Dose escalation (enrollment into the next cohort) cannot occur until all three subjects have completed the previous cohort; 5 doses will be tested. An additional dosing regimen has been added to evaluate higher doses given twice weekly for 7 weeks. Therefore, the full evaluation period for each patient will extend out to approximately eleven weeks after the first day of SB-485232 dosing.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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 or cytologically confirmed diagnosis of malignancy.
- •Subjects with solid tumors must have locally advanced or metastatic disease at the time of enrollment.
- •Measurable or evaluable disease that is refractory or resistant to standard therapy or for which there is no effective standard therapy.
- •Predicted life expectancy of at least 12 weeks.
- •Kinesin spindle protein (KPS) of greater than 70%.
- •No chemotherapy, immunotherapy, hormonal therapy, or biological therapy for cancer, radiotherapy, or surgical procedures (except for minor surgical procedures) within 4 weeks before beginning treatment with SB-485232 (6 weeks for nitrosoureas and mitomycin C).
- •Subjects must have recovered from toxicities (incurred as a result of previous therapy) sufficiently to be entered into a Phase I study.
- •Provide written informed consent.
- •Absence of anti-SB-485232 antibodies.
- •Hemoglobin greater than or equal to 9 g/dL.
- •Absolute neutrophil count greater than or equal to 1.5 X 109 /L.
- •Platelet count greater than or equal to 100 X 109 /L.
- •Partial thromboplastin time (PTT) and prothrombin time/international normalized ratio (PT/INR) within normal limits.
- •Serum creatinine less than or equal to 1.5 mg/dL (135 µmol/L) or estimated creatinine clearance greater than 50 mL/min (calculated by the Cockcroft-Gault Formula).
- •Total serum bilirubin less than or equal to 1.5 mg/dL.
- •Aspartate transaminase (AST) and alanine transaminase (ALT) less than or equal to 3 X ULN.
- •Sexually active males or females of reproductive capacity must use adequate contraception.
- •For subjects with a history of coronary artery disease, stress test must be within normal limits.
- •Subjects with a history of congestive heart failure, myocardial infarction or prior anthracycline chemotherapy must have a Multiple Gated Acquisition (MUGA) scan with a left ventricular ejection fraction of greater than 40%.
排除标准
- •Women who are pregnant or are breast-feeding.
- •Severe or uncontrolled infections requiring systemic antibiotic therapy.
- •Any serious medical or psychiatric disorder that would interfere with subject safety or informed consent.
- •Known leptomeningeal disease or evidence of prior or current metastatic brain disease.
- •Receiving concurrent chemotherapy, immunotherapy, radiotherapy, or investigational therapy.
- •Receiving concurrent systemic steroids.
- •History of ventricular arrhythmias requiring drug or device therapy.
- •Any severe concurrent disease or condition, including significant autoimmune diseases, which in the judgment of the principal investigator, would make the subject inappropriate for study participation.
- •Any unresolved or unstable serious toxicity from prior administration of another investigational drug.
- •Any investigational drug within 30 days or 5 half-lives (whichever is longer) preceding the first dose of SB-
- •Psychological, familial, sociological, or geographical conditions that do not permit compliance with the study.
- •Received prior treatment with SB-
- •Poor venous access.
结局指标
主要结局
- Safety and tolerability endpoints will include evaluation of adverse events and changes in laboratory values and clinical variables from pre-dose values.
时间窗: 11 Weeks
次要结局
- - Biologically effective dose based. - Pharmacokinetic endpoints: AUC, Adverse Events, cmax, tmax, and t1/2. - Presence or absence of anti-SB-485232 antibodies. - Pharmacodynamic endpoints. - Radiographic tumor assessments.(11 Weeks)
研究者
研究点 (5)
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