NCT00607711暂停1 期
A Phase I Study of Oral Palifosfamide Tris in Advanced, Refractory, Solid Tumors
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 暂停
- 入组人数
- 20
- 主要终点
- Toxicities
研究概览
简要总结
The study of maximum tolerated dose and safety of oral palifosfamide tris capsules in advanced, refractory, solid tumors
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
- •Subjects with histological or cytological confirmation of advanced cancer that is refractory to standard therapies for their condition.
- •Men and women of ≥18 years of age.
- •Life expectancy of at least 12 weeks.
- •Eastern Cooperative Oncology Group (ECOG) performance score ≤2 (see Appendix 4).
- •Eligible subjects MUST have at least one measurable lesion as defined by RECIST guidelines. If the measurable disease is restricted to a solitary lesion, its neoplastic nature should be confirmed by cytology/histology. Measurable lesions must NOT have been in a previously irradiated field or injected with biological agents.
- •Adequate bone marrow, liver and renal function as assessed by the following laboratory requirements, to be conducted ≤2 weeks prior to Baseline:
- •Creatinine < 1.5× upper limit of normal (ULN) OR a calculated creatinine clearance ≥70 cc/min
- •Total bilirubin ≤2×ULN
- •Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤3×ULN
- •Granulocytes in peripheral blood ≥2.0×109/L, hemoglobin ≥8.5 g/dL, and platelets ≥50,000/µL
- •Written informed consent in compliance with ZIOPHARM policies and the Human Investigation Review Committee (IEC/IRB) having jurisdiction over the site.
- •Men and women of childbearing potential must use effective contraception from Screening through his/her duration of study participation.
- •Women of childbearing potential must have a negative serum pregnancy test prior to entering the study.
排除标准
- •New York Heart Association (NYHA) functional Class ≥III myocardial infarction (see Appendix 5) within 6 months.
- •Uncontrolled cardiac arrhythmia other than asymptomatic atrial fibrillation; a QTc ≥450 msec; or a ≥Grade 2 atrioventricular (AV) block or left bundle branch block (LBBB); or documented history of prolonged QTc.
- •Pregnancy and/or lactation.
- •Uncontrolled systemic infection (documented with microbiological studies).
- •Inadequate renal function as defined by the presence of one or more of the following:
- •Creatinine clearance (CrCl) <70 cc/min
- •Serum creatinine >1.5×ULN
- •Prior nephrectomy
- •Urinary tract obstruction
- •Anticancer chemotherapy or immunotherapy during the study or within 4 weeks of study entry (mitomycin C or nitrosureas should not be given within 6 weeks of study entry).
- •Radiotherapy during study or within 3 weeks of study entry.
- •Surgery within 4 weeks of start of study drug.
- •Other investigational drug therapy outside of this trial during or within 4 weeks of study entry.
- •History of invasive second primary malignancy diagnosed within the previous 3 years except for Stage I endometrial/cervical carcinoma or prostate carcinoma treated surgically, and non-melanoma skin cancer.
- •Substance abuse, medical, psychological, or social conditions that may interfere with the subject's participation in the study or evaluation of study results.
- •Any condition that is unstable or could jeopardize the safety of the subject and his/her compliance in the study.
研究组 & 干预措施
Single arm
Experimental
干预措施: oral palifosfamide tris (Drug)
结局指标
主要结局
Toxicities
时间窗: 9 months
次要结局
- Safety(9 months)
研究者
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