NL-OMON30871已完成2 期
A Phase I Study of Oral Topotecan in Subjects with Cancer and Impaired Renal Function - Study of Oral Topotecan in Subjects with Cancer and Impaired Renal Function
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 12
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. Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
- •2. Age 18 years or older.
- •3. A performance status score of 0, 1, or 2 on the Eastern Cooperative Oncology Group (ECOG) Scale.
- •4. Histologically- or cytologically-confirmed advanced solid tumours.
- •5. Failed conventional therapy for their tumor type; or subjects who have a tumor type for which no standard effective therapy exists; or subjects for whom single-agent topotecan therapy is suitable.
- •6. Completion of a 24-hour urine collection within 14 days prior to the first dose to calculate the creatinine clearance value and determine the renal impairment category.
- •7. Documentation of a stable renal function for at least 14 days prior to first scheduled dose using the Cockcroft-Gault formula, and at least 2 serum creatinine values separated by a minimum of 7 days. Stable renal function is defined as:
- •a. < or = 25% change of CrCl<40 mL/min
- •b. < or = 10 mL/min change for CrCl > or = 40mL/min
- •NOTE: Documentation of stable renal function will NOT be required if the 24-hour urine collection to determine the renal impairment category is completed within 7 days prior to the first dose.
排除标准
- •1. Currently undergoing dialysis.
- •2. Pregant or lactating
- •3. Women of childbearing potential who refuse to either abstain from secual intercourse or practice adequate contraception defined as:
- •a. complete abstinence from sexual intercourse for 14 days before exposure to study drug, continuing throughout the clinical trial, and for a period of at least 14 days after the last dose of study drug;
- •b. oral contraceptives or intrauterine device [IUD] initiated at least 3 months prior to start of the study medication;
- •c. double barrier such as diaphragm plus spermicide;
- •d. vasectomized partner who is sterile prior to the female subject*s entry and is the sole sexual partner of that female.
- •Childbearing potential is defined as women who are not surgically sterilized (i.e., have not had a hysterectomy, bilateral oophorectomy [ovariectomy], or bilateral
- •tubal ligation) or post-menopausal (i.e., documented absence of menses for one year prior to entry into the study).
- •4. Male subjects with female partners of childbearing potential who have not had a prior vasectomy or if both the male subject and the female partner refuse to:
- •use adequate contraception (as described above) beginning 14 days before exposure to study drug, continuing throughout the clinical trial, and for a period of 3 months after the last dose of study drug.
- •5. Uncontrolled emesis, regardless of etiology.
- •6. Bilirubin > 1.5 X ULN.
- •7. SGOT/AST, SGPT/ALT and alkaline phosphatase > 2 times the upper limit of normal (ULN) if liver metastases cannot be visualized by abdominal computed tomography (CT) or magnetic resonance imaging (MRI). If liver metastases are present, subjects with <5 times ULN are eligible to participate, following discussion with and approval from a GSK Medical Monitor.
研究者
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