NL-OMON42076招募中不适用
A Phase 1, Open-label Clinical Study to Assess the Pharmacokinetics (Distribution, Metabolism,;and Excretion) of 14C-Vosaroxin in Patients with Advanced Solid Tumors - VOS-ADME-101
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 6
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •1. Able to understand and provide written informed consent;
- •2. At least 18 years old at the time of informed consent;
- •3. Histologically or cytologically confirmed diagnosis of advanced solid tumors (ie, breast, lung, head/neck, colorectal, melanoma, and sarcoma). The malignancy must be considered unresponsive to accepted available therapies;
- •4. ECOG performance status of 0, 1, or 2;
- •5. Life expectancy of >= 3 months;
- •6. Acceptable recovery from clinically significant nonhematologic toxicity after prior therapy;
- •7. If female, must be surgically or biologically sterile or postmenopausal (amenorrheic for at least 12 months) or if of childbearing potential, must have a negative urine or serum pregnancy test within 14 days before randomization, and must agree to use an adequate method of contraception during the study until 30 days after the last treatment. Males must be surgically or biologically sterile or agree to use an adequate method;
- •of contraception during the study until 30 days after the last treatment;
- •8. Adequate renal function (normal to mild dysfunction), with a serum creatinine value of >1.5 x the upper limit of normal (ULN) and with a calculated creatinine clearance (CLCR) of >=40 mL/minute;
- •9. Adequate hepatic function defined as follows;
- •- total bilirubin <= 1.5 x ULN, unless due to Gilbert*s syndrome;
- •- aspartate aminotransferase (AST) <= 2.5 x ULN;
- •- alanine aminotransferase (ALT) <= 2.5 x ULN;
- •10. Willing and able to comply with study restrictions and to remain at the study center for the required duration during Assessment Period A;
- •11. Able to tolerate a high fiber diet (at least 25 g/day).
排除标准
- •1. Prior chemotherapy, radiotherapy, radioimmunotherapy, or immunotherapy within 28 days of the first dose of study treatment or has not recovered from adverse events (AEs) due to any agents administered previously;
- •2. Presence of known brain metastases or active central nervous system (CNS) disease;
- •3. Prior treatment with vosaroxin within 60 days of enrollment;
- •4. Prior treatment with any hematopoietic growth factors within 14 days of study entry (patients on chronic erythropoiesis stimulating agents are allowed);
- •5. New York Heart Association Class 3 or 4 heart disease, active ischemia, or any uncontrolled, unstable cardiac condition for which treatment for the condition is indicated but is not controlled despite adequate therapy, including angina pectoris, cardiac arrhythmia, hypertension, or congestive heart failure;
- •6. Myocardial infarction within the previous 12 weeks;
- •7. Active, uncontrolled systemic infection considered opportunistic, life threatening, or clinically significant at the time of treatment;
- •8. Pregnant or lactating;
- •9. Known positive test result for hepatitis B surface antigen (HBsAg) or hepatitis C antibodies (HC Ab) or has a known positive test result for human immunodeficiency virus (HIV) or a history of HIV disease.;10. Presence of inflammatory bowel disease, occlusion of the gastrointestinal tract, significant constipation, or any condition resulting in clinically significant obstruction of the gastrointestinal tract.;11. History of biliary obstruction or cholecystectomy.;12. Any condition resulting in a clinically significant obstruction of the urinary tract.;13. Known hypersensitivity to vosaroxin or any other components of the study treatment.;14. Serious medical or psychiatric condition that, in the opinion of the Investigator, should preclude the patient from participating in the study.
研究者
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