NCT00743028已完成1 期
A Single Dose Study Evaluating the Oral Bioavailability and Pharmacokinetics of the Capsule Formulation of ABT-263 in Subjects With Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Abbott
- 入组人数
- 36
- 试验地点
- 5
- 主要终点
- Assess the oral bioavailability of a new ABT-263 formulation relative to that of the current ABT-263 formulation being assessed in ongoing Phase 1/2a studies.
研究概览
简要总结
This is a randomized, open-label, multicenter crossover study to determine the oral bioavailability of new ABT-263 formulations relative to that of the current ABT-263 formulation being administered in ongoing Phase 1/2a studies. Approximately 36 evaluable subjects with lymphoid malignancies, including chronic lymphocytic leukemia, and solid tumors will be enrolled in this study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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
- •> or =18 years of age;
- •Non-hematologic malignancy or hematologic malignancy that is either relapsed or refractory to standard therapy, or failed up to 5 prior standard therapies or no know effective therapy exists;
- •Life expectancy is at least 90 days;
- •If clinically indicated, (e.g., subjects over the age of 70) subjects must have documented brain imaging (MRI or CT) negative for subdural or epidural hematoma within 28 days prior to the 1st dose of study drug;
- •ECOG performance score of < or = 1;
- •Adequate bone marrow, renal and hepatic function per local laboratory reference range as follows:
- •ANC > or = 1,000/µl;
- •Platelets > or = 100,000/mm3;
- •Hemoglobin > or = 9.0 g/dL;
- •serum creatinine < or = 2.0 mg/dL or calculated creatinine clearance > or = 50;
- •AST and ALT < or = 3.0 x ULN; Bilirubin < or = 1.5 x ULN. Gilbert's Syndrome may have a Bilirubin > 1.5 x ULN;
- •aPTT, PT not to exceed 1.2 x ULN;
- •Females must be surgically sterile, postmenopausal, have negative pregnancy test at screening;
- •Females not surgically sterile or postmenopausal & non-vasectomized males must practice at least one of the following methods of birth control:
- •Total abstinence from sexual intercourse (minimum one complete menstrual cycle prior to starting study drug);
- •Vasectomized partner;
- •Hormonal contraceptives for at least 3 months prior to study;
- •Double-barrier method (including condoms, contraceptive sponge, diaphragm or vaginal ring with spermicidal jellies or cream).
排除标准
- •History of/clinically suspicious for cancer-related CNS disease; An allogeneic stem cell transplant.
- •Underlying, predisposing condition of bleeding/currently exhibits signs of bleeding.
- •History of non-chemotherapy induced thrombocytopenic associated bleeding w/i 1 year prior to the 1st dose.
- •Peptic ulcer disease or other hemorrhagic esophagitis/gastritis.
- •Active ITP/ history of being refractory to platelet transfusions.
- •Significant history of cardiac, renal, neurologic, psychiatric, endocrinologic, metabolic, immunologic/hepatic disease.
- •Females pregnant or breast-feeding.
- •History of or active medical condition(s) that affects absorption or motility.
- •Positive for HIV.
- •Other clinically significant uncontrolled condition(s) including, but not limited to: active systemic fungal infection; neutropenic fever w/i 1 wk prior to study drug.
- •Steroid therapy w/i 7 days prior to 1st dose for anti-cancer intent.
- •Anti-cancer therapy including chemotherapy, immunotherapy, radiotherapy, hormonal (except hormones for hypothyroidism or ERT)/agonists required to suppress serum testosterone levels [e.g. LHRH, GnRH], any investigational therapy w/i 14 days prior to first dose of study drug.
- •Biologic agent w/i 30 days prior to 1st dose.
- •Anticoagulation therapy/drugs/herbal supplements affecting platelet function.
- •Aspirin w/i 7 days prior to 1st dose.
- •Grapefruit/grapefruit products.
研究组 & 干预措施
1
Experimental
干预措施: ABT-263 (Drug)
2
Experimental
干预措施: ABT-263 (Drug)
3
Experimental
干预措施: ABT-263 (Drug)
4
Experimental
干预措施: ABT-263 (Drug)
5
Experimental
干预措施: ABT-263 (Drug)
6
Experimental
干预措施: ABT-263 (Drug)
结局指标
主要结局
Assess the oral bioavailability of a new ABT-263 formulation relative to that of the current ABT-263 formulation being assessed in ongoing Phase 1/2a studies.
时间窗: Two Period crossover design.
Assess the oral bioavailability of a new ABT-263 formulation relative to that of the current ABT-263 formulation being assessed in ongoing Phase 1/2a studies and assess new ABT-263 formulations after once daily dosing (QD) and twice daily dosing (BID).
时间窗: Three Period crossover design.
次要结局
- Safety measures include number and percentage of subjects having treatment-emergent adverse events tabulated by MedDRA system organ class and preferred term, laboratory test results, lymphocyte enumeration results, vital signs, etc.(Two and three period crossover design)
研究者
研究点 (5)
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