NCT01678690已完成早期 1 期
An Open-Label, Exploratory, Limited Dose Escalation Study to Evaluate the Pharmacokinetics, Safety and Tolerability of Gemcitabine Hydrochloride Oral Formulation (D07001-F4) in Subjects With Malignant Tumors
适应症
干预措施
相关药物
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 11
- 试验地点
- 3
- 主要终点
- gemcitabine (dFdC) and difluorodeoxyuridine (dFdU) plasma concentration and gemcitabine triphosphate (dFdCTP) concentration in PBMC
研究概览
简要总结
Open-label, Phase 0, dose-escalation study of 3 successive cohorts (3 subjects per cohort), to determine and characterize the plasma PK of gemcitabine HCl oral formulation (D07001-F4) administered once on Day 1 with 7 Days of study follow-up. In addition, oral tolerability and safety will also be assessed during this 1-week period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Male or female subjects aged 18 years and older.
- •Signed and dated informed consent form.
- •Subjects with malignancies with histological or pathologic confirmation and who are clinically stable.
- •History of treatment with at least 1 cytotoxic chemotherapy regimen for the current malignancy.
- •If the subject has received cytotoxic chemotherapy within the past 14 days, the subject is beyond the nadir of white blood cell and platelet counts.
- •At least 28 days have elapsed since the subject's prior radiotherapy or any major surgery (excluding diagnostic biopsy or venous access device placement).
- •World Health Organization (WHO) performance status 0 to 2
- •Subject has an ANC ≥1500 cells/mm³, platelet count ≥ 100,000 cells/mm³, and hemoglobin ≥ 9 g/dL.
- •Subject has adequate liver function demonstrated by transaminases within normal limits (aspartate transaminase and alanine transaminase), total bilirubin ≤ 1.5 mg/dL (unless due to Gilbert's syndrome), albumin ≥ 2.5 g/dL, international normalized ratio [INR] < 1.5).
- •Subject has adequate renal function: serum creatinine ≤ 1.5 x upper limit of normal.
- •Subject has a life expectancy >24 weeks.
- •If a women of child-bearing potential, subject has a negative pregnancy test and is not breast-feeding.
- •If a women of child-bearing potential, subject is using a medically acceptable form of birth control prior to screening and for the duration of their study participation and for 1 month after the end of the study.
- •Subject is willing to comply with protocol-required visit schedule and visit requirements and provide written informed consent.
排除标准
- •Subject has rapidly progressive disease or rapid clinical deterioration as assessed by the Investigator.
- •Subject is receiving full-dose (therapeutic) anticoagulation therapy.
- •Subject is receiving concomitant radiotherapy.
- •Subject is intolerant or allergic or has a known hypersensitivity to gemcitabine.
- •Subject has clinically significant cardiovascular disease (for example: uncontrolled hypertension, unstable angina, congestive heart failure, or New York Heart Association Grade 2 or greater).
- •Subject has uncontrolled serious cardiac arrhythmia.
- •Subject has known active brain metastases, or any leptomeningeal metastases.
- •Subject has a history of drug or alcohol abuse within last year.
- •Subject has documented cerebrovascular disease.
- •Subject has a seizure disorder not controlled on medication.
- •Subject received an investigational agent within 30 days of screening.
- •Subject received systemic treatment for infection within 14 days of screening.
- •Subject has known human immunodeficiency virus infection or viral hepatitis.
- •Subject has any other serious medical condition that, in the investigator's medical opinion, would preclude safe participation in a clinical trial.
- •Subject has gastrointestinal disease or prior gastrointestinal surgery that may interfere with adequate oral therapy absorption.
研究组 & 干预措施
Gemcitabine HCl Oral Formulation
Experimental
Subjects will be treated with Gemcitabine HCl Oral Formulation according to assigned cohort (2 mg or 5 mg or 10 mg) on Day 1 of the 7-day study treatment period
干预措施: Gemcitabine HCl Oral Formulation (Drug)
结局指标
主要结局
gemcitabine (dFdC) and difluorodeoxyuridine (dFdU) plasma concentration and gemcitabine triphosphate (dFdCTP) concentration in PBMC
时间窗: Day 1-5
次要结局
- the proportion of subjects experiencing adverse events all grades, change from baseline in clinical laboratory test results, vital sign measurements, and physical examination findings(Day 1-8 (+/- 1) days)
研究者
研究点 (3)
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