NCT00635284已完成1 期
A Phase I Trial of ABI-009 (Nab-rapamycin) Administered Weekly in Patients With Advanced Non-hematologic Malignancies
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
- Celgene
- 入组人数
- 27
- 试验地点
- 2
- 主要终点
- Determine the maximum tolerated dose (MTD) and dose limiting toxicities (DLTs) of ABI-009 administered weekly and pharmacokinetic parameters for ABI-009.
研究概览
简要总结
To determine the maximum tolerated dose (MTD) and dose limiting toxicities (DLTs) of ABI-009 given weekly; to characterize the toxicities of ABI-009; and to determine the pharmacokinetic parameters for ABI-009 when given on a weekly schedule.
详细描述
No extended description necessary
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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
- •Each subject must meet the following criteria to be enrolled in this study.
- •Male and female patients with histologically or cytologically confirmed diagnosis of cancer which is not amenable to curative therapy.
- •Patients with advanced non-hematologic malignancies for whom no standard therapy exists.
- •Measurable disease by RECIST or evaluable disease (e.g., bone metastasis, pleural effusion, ascites, or lesions which do not fulfill RECIST criteria for metastatic disease)
- •Off all therapy (inclusive of investigational therapies) for at least 4 weeks prior to study drug administration OR off all daily or weekly therapy (inclusive of investigational therapies) for at least 2 weeks prior to study drug administration and without any side effects associated with these therapies.
- •Female patients of child-bearing potential must have a negative serum pregnancy test within 7 days prior to first study drug administration.
- •Female patients who are postmenopausal must have 12 months of amenorrhea, surgically sterile, or must agree to the use of a physical method of non-hormonal contraception.
- •Male patients must be surgically sterile or agree to the use of a barrier method of contraception.
- •Life expectancy of > 3 months.
- •ECOG Performance Status of 0-
- •Patients must be able to provide informed consent indicating knowledge of his/her disease process, the investigational nature of the therapy, alternatives, benefits, and risks including potential side effects.
- •Age ≥ 18 years of age.
- •No major surgery within 4 weeks before treatment with ABI-
- •(A biopsy is not considered major surgery).
- •No chemotherapy, hormonal therapy, immunotherapy or radiotherapy within 4 weeks before treatment with ABI-009 (6 weeks for previous treatment with nitrosoureas, mitomycin, or extensive radiotherapy) and no immunosuppressive agents within 3 weeks before study entry (except corticosteroids used as antiemetics).
- •No immunosuppressive agents within 3 weeks before study entry (except corticosteroids used as antiemetics).
- •Required Initial Laboratory Data:
- •Hemoglobin > 9.0 g/dL
- •WBC ≥ 3,000/µl
- •ANC ≥ 1,500/µl
- •Platelet count ≥ 100,000/µl
- •Total Bilirubin ≤ ULN
- •SGOT (AST) SGPT (ALT) ≤ 1.5 x ULN ≤ 1.5 x ULN
- •Serum Cholesterol < 350 mg/dL
- •Serum Triglyceride < 300 mg/dL
- •Adequate renal function with serum creatinine < 1.5 mg/dL and/or creatinine clearance (cockroft formula) ≥ 60 mL/min.
- •No active alcohol abuse, drug addiction, or psychotic disorders.
- •No known concomitant genetic or acquired immunosuppressive diseases (such as AIDS).
- •If obese, a patient must be treated with doses calculated using his/her actual BSA (The physician must be comfortable treating at the full BSA dose regardless of BSA).
排除标准
- •Subjects who meet any of the following criteria will be excluded from the study.
- •Pregnant or nursing women.
- •History of allergic reactions attributed to compounds of similar chemical or biologic composition including macrolide (e.g. azithromycin, clarithromycin, dirithromycin, and erythromycin) and ketolide antibiotics.
- •Patients have not recovered from adverse affects of radiation therapy or investigational agent within previous 28 days.
- •Uncontrolled intercurrent illness that in the opinion of the investigator would limit compliance and tolerance to study requirements
- •Patients with known brain metastases or leptomeningeal tumor involvement.
- •Receiving any of the following: concomitant antitumor therapy or inhibitors of CYP3A
- •Patients with history of interstitial lung disease and/or pneumonitis.
研究组 & 干预措施
ABI-009
Experimental
干预措施: ABI-009 (Drug)
结局指标
主要结局
Determine the maximum tolerated dose (MTD) and dose limiting toxicities (DLTs) of ABI-009 administered weekly and pharmacokinetic parameters for ABI-009.
时间窗: End of Study (EOS) and Follow Up
次要结局
- Efficacy of ABI-009 in this patient population(End of Study (EOS) and Follow Up)
研究者
研究点 (2)
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