NCT00820768撤回1 期
A Phase I of ABI-010 (Nab-17-AAG) and ABI-007 (Abraxane) 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
- 撤回
- 发起方
- Celgene
- 试验地点
- 1
- 主要终点
- The primary objectives of this study are to determine the maximum tolerated dose (MTD) and dose-limiting toxicities (DLTs) of ABI-010 given weekly for 3 weeks followed by 1 week of rest (Cycle 1); to determine MTD and DLTs of ABI-010 given in combination
研究概览
简要总结
To determine MTD and DLT of ABI-010 given weekly every three weeks followed by one week of rest (Cycle 1). Determine MLD and DLT in combination with ABI-007; to characterize the toxicities of ABI-010 alone and in combination with ABI-007.
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:
- •Pathologically confirmed advanced solid tumor malignancy.
- •Measurable or evaluable advanced solid tumors.
- •Patients with advanced solid tumor malignancy who failed standard therapy or for whom no standard therapy exists. Patients failing standard therapy should have received no more than 3 prior chemotherapy regimens.
- •Patients must have recovered for at least 3 weeks from prior treatment regimens and have no residual toxicity > Grade 2 (with the exception of peripheral neuropathy which must have improved to ≤ Grade 1).
- •Patient should have full recovery from any reversible side effects of prior chemotherapy.
- •Patient should have full recovery for at least 4 weeks since major surgery.
- •ECOG performance status 0-
- •Age ≥18 years.
- •Patient must have the following blood counts at Baseline:
- •WBC ≥ 3.0 x 10 cells/L.
- •ANC ≥ 1.5 x 10 cells/L.
- •Platelets ≥ 100 x 10 cells/L.
- •Hgb ≥ 9grams/dL.
- •Patient must have the following blood chemistry levels at Baseline:
- •AST (SGOT), ALT (SGPT) ≤ 1.5x upper limit of normal range (ULN);
- •Total Bilirubin ≤ ULN;
- •Alkaline phosphatase ≤ 2.5x ULN (unless bone metastasis is present in the absence of liver metastasis;
- •Creatinine ≤ 1.5 mg/dL
- •Peripheral neuropathy Grade ≤ 1 by NCI CTCAE V3.
- •Female of childbearing potential with negative serum pregnancy test within 72 hours prior to the first dose of study drug.
- •Males and females with reproductive potential must agree to utilize contraception considered adequate and appropriate by the investigator (including one barrier method) for the duration of the study and for 2 months after the end of study.
- •Life expectancy ≥ 3 months.
- •Informed consent document has been obtained.
- •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.
- •Concurrent therapy (chemotherapy, hormonal therapy, kinase inhibitors, immunotherapy, etc) for advanced solid tumor.
- •Patients receiving known CYP450 3A4 inhibitors.
- •Bisphosphonate therapy is allowed, however, patients should be stable on their current bisphosphonate, with no change, start or stop of treatment within 4 weeks prior to enrollment.
- •Patients with known brain metastases or leptomeningeal tumor involvement should be excluded from this clinical trial.
- •Uncontrolled intercurrent illness including, but not limited to, serious ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/ social situations that would limit compliance with study.
- •Patients with significant cardiovascular disease including congestive heart failure (New York Heart Association Class III or IV), active angina pectoris or recent myocardial infarction (within the last 6 months).
- •History of other malignancy within the last 5 years which would affect the diagnosis or assessment of advanced solid tumor excluding non-melanomatous skin cancer and cervical carcinoma.
- •Patients who have received an investigational drug within the previous 3 weeks.
- •Patient is currently enrolled in any other clinical study in which investigational procedures are performed or investigational therapies are administered. A patient may not enroll in such clinical trials while participating in this study.
- •Pregnant or nursing women.
- •Patients with history of allergy or hypersensitivity to the study drug or its excipients.
- •Patients with marked baseline prolongation of QT/QTc interval (>450 milliseconds).
研究组 & 干预措施
ABI-010
Experimental
干预措施: ABI-010 (Drug)
结局指标
主要结局
The primary objectives of this study are to determine the maximum tolerated dose (MTD) and dose-limiting toxicities (DLTs) of ABI-010 given weekly for 3 weeks followed by 1 week of rest (Cycle 1); to determine MTD and DLTs of ABI-010 given in combination
时间窗: EOS and Follow-Up
次要结局
- To determine the pharmacokinetic parameters for ABI-010 when given on a weekly schedule alone and in combination with ABI-007; determine preliminary efficacy of ABI-010 when given on a weekly schedule in combination with ABI-007(EOS and Follow-Up)
研究者
研究点 (1)
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