NCT00708591已完成1 期
A Phase Ib Study Administering Rapamycin (Sirolimus) With Ketoconazole in Patients With Advanced 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
- 入组人数
- 57
- 试验地点
- 1
- 主要终点
- maximum tolerated dose
研究概览
简要总结
To determine the maximum tolerated dose, observed toxicities, and dose limiting toxicities, and antitumor response of rapamycin plus ketoconazole in patients with advanced cancers.
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
- •Histologically confirmed malignancy that is metastatic or unresectable and for which standard curative or palliative measures do not exist or are no longer effective.
- •Patients with hematologic malignancies (lymphoma, multiple myeloma and CLL only) are eligible to participate in the phase Ib portion of the trial only
- •At least 4 weeks since prior chemotherapy or radiation therapy (6 weeks if the last regimen included BCNU or mitomycin C).
- •Age >18 years.
- •ECOG performance status less than or equal to 2
- •Life expectancy of more than 3 months.
- •Normal organ and marrow function as defined below:
- •Hemoglobin ≥ 10 g/dl
- •Leukocytes ≥ 3,000/µL
- •o WBC ≥ 1,500/µL for patients with hematologic malignancies
- •Absolute neutrophil count ≥ 1,500/µL (≥ 1,000/µL for patients with hematologic malignancies)
- •Absolute lymphocyte count ≥1000/µL
- •Platelets ≥ 100,000/µL (≥ 50,000/µL for patients with hematologic malignancies)
- •Total bilirubin within normal institutional limits
- •AST (SGOT) and ALT (SGPT) ≤ 2.5 times institutional ULN
- •Serum triglycerides ≤ 500 mg/dl
- •Creatinine within normal institutional limits OR
- •Creatinine clearance ≥ 60 mL/min/1.73 m2 for patients with creatinine levels above institutional normal.
- •Women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation.
- •Able to understand and the willing to sign a written informed consent document.
排除标准
- •Chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or not recovered from adverse events due to agents administered more than 4 weeks earlier.
- •Receiving any other investigational agents.
- •Uncontrolled brain metastases or malignancy.
- •History of allergic reactions attributed to compounds of similar chemical or biologic composition to rapamycin.
- •Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- •Severe immunodeficient state (as judged by the treating physician)
- •Pregnancy (breast-feeding must be discontinued)
- •HIV-positive patients receiving combination anti-retroviral therapy are excluded from the study because of possible pharmacokinetic interactions with rapamycin.
- •Concurrent use of cyclosporine, tacrolimus, and rifampin, terfenadine, astemizole, cisapride, rosiglitazone or pioglitazone due to possible interactions with the study drugs. Ketoconazole cannot be taken within 2 hours of an antacid.
研究组 & 干预措施
1
Experimental
干预措施: Rapamycin (Drug)
1
Experimental
干预措施: Ketoconazole (Drug)
结局指标
主要结局
maximum tolerated dose
时间窗: 4 weeks
次要结局
- observed toxicities(4 weeks)
- anti-tumor response(8 weeks)
研究者
研究点 (1)
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