NCT00288444终止1 期
Defining the Interaction of Docetaxel and Lonafarnib 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
- 终止
- 入组人数
- 38
- 试验地点
- 1
- 主要终点
- Determine the molecular interaction
研究概览
简要总结
To determine the molecular interaction in tumor samples between docetaxel and lonafarnib.
详细描述
- To determine the safety and toxicity of intravenous docetaxel, administered on a weekly schedule (3 weeks out of 4), in combination with oral lonafarnib, administered on a daily schedule, in patients with locally advanced and metastatic solid tumor malignancies which are refractory to the standard of care.
- To determine the pharmacokinetic interaction between docetaxel and lonafarnib.
- To determine the molecular interaction in peripheral blood mononuclear cells between docetaxel and lonafarnib
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •.1.1 Patient must have a pathologically-confirmed locally advanced or metastatic solid tumor malignancy demonstrated to be refractory to the standard of care, with tumors accessible by needle or surgical biopsy.
- •3.1.2 Only patients determined to be at minimal risk to receiving the biopsy (with tumor location/accessibility as well as underlying patient comorbidities judged to allow a minimal risk biopsy by the radiologist/surgeon performing the procedure) will be eligible for this study.
- •3.1.3 Patient must have an ECOG performance status of 2 or less.
- •3.1.4 Patient must have a life-expectancy of at least 12 weeks.
- •3.1.5 Patient must have adequate bone marrow function: WBC ≥ 3,000 cells/mm3, ANC ≥ 1,500 cells/mm3, platelet count ≥ 100,000/mm3 and Hgb ≥ 9.0 g/dL.
- •3.1.6 Patient must have adequate liver function: total bilirubin level ≤ 2.0 mg/dL and ≤ ULN, albumin ≥ 2.5 g/dL.
- •3.1.7 Patient must have adequate renal function: Transaminases/Alkaline phosphatase: AST or ALT and alkaline phosphatase must be within the range allowing for eligibility. This range is defined as ≤ 2 x ULN.
- •In determining eligibility, the more abnormal of the two (AST or ALT) should be used.
- •3.1.8 Patient must have received no more than three previous chemotherapy regimens (prior chemotherapy may or may not have contained a taxane).
- •3.1.9 Patient must meet the specified informed consent requirement.
- •3.1.10 Patient must be of age ≥ 18 years.
- •3.1.11 Women of childbearing age must have a negative pregnancy test.
- •3.1.12 Men and women of childbearing potential must be willing to consent to using effective contraception while on treatment and for at least 3 months thereafter.
- •3.1.13 Patient must have ≤ Grade 1 neurotoxicity from previous anticancer treatment or from any cause.
- •3.1.14 Patient must have adequate coagulation function: INR and PTT ≤ 1.5 x ULN.
- •3.1.15 Patient must have discontinued all prior chemotherapy and radiotherapy at least 4 weeks prior to registration.
- •3.1.16 Patient must have discontinued use of the following drugs which are an inducers or inhibitors of CYP3A4 at least 2 days prior to registration: ethinylestradiol, gestodene, itraconazole, ketoconazole, cimetidine, erythromycin, carbamazepine, high dose chronic steroids, phenobarbital, phenytoin, rifampin (rifampcin), and sulfinpyrazone.
- •Patient must have a pathologically-confirmed
排除标准
- •3.2.1 Patient has received more than three previous chemotherapy regimens.
- •3.2.2 Patient is pregnant or breast feeding.
- •3.2.3 Patient has signs of symptoms of acute infection requiring systemic therapy.
- •3.2.4 Patient exhibits confusion, disorientation, or has a history of major psychiatric illness which may impair the patient's understanding of the informed consent.
- •3.2.5 Patient's life expectancy is less than 12 weeks.
- •3.2.6 Patient has > Grade 1 neurotoxicity from previous anticancer treatment or significant neuropathy from any cause.
- •3.2.7 Patient requires total parenteral nutrition with lipids.
- •3.2.8 Inability to swallow the lonafarnib BID.
- •3.2.9 Patient has a history of uncontrolled heart disease (including clinically significant coronary artery disease, congestive heart failure and symptomatic or uncontrolled arrythmias).
- •3.2.10 Patient has a history of severe hypersensitivity reaction to docetaxel or other drugs formulated with polysorbate
- •Symptoms include: any reaction such as bronchospasm, generalized urticaria, systolic BP ≤ 80mm Hg, and angioedema.
- •3.2.11 Use of chronic steroids or anticonvulsants.
研究组 & 干预措施
Docetaxel 36 mg/ m2 IV weekly and Lonafarnib 150 mg
Active Comparator
Docetaxel 36 mg/ m^2 Intravenously weekly and Lonafarnib 150 mg by mouth twice a day daily.
干预措施: Lonafarnib (Drug)
Docetaxel 36 mg/ m2 IV weekly and Lonafarnib 150 mg
Active Comparator
Docetaxel 36 mg/ m^2 Intravenously weekly and Lonafarnib 150 mg by mouth twice a day daily.
干预措施: Docetaxel (Drug)
Docetaxel 30 mg/ m2and Lonafarnib 150 mg
Active Comparator
Docetaxel 30 mg/ m^2 Intravenously weekly and Lonafarnib 150 mg by mouth twice a day daily.
干预措施: Lonafarnib (Drug)
Docetaxel 30 mg/ m2and Lonafarnib 150 mg
Active Comparator
Docetaxel 30 mg/ m^2 Intravenously weekly and Lonafarnib 150 mg by mouth twice a day daily.
干预措施: Docetaxel (Drug)
Docetaxel 36 mg/ m2 and Lonafarnib 100 mg
Active Comparator
Docetaxel 36 mg/ m^2 Intravenously weekly and Lonafarnib 100 mg by mouth twice a day daily
干预措施: Lonafarnib (Drug)
Docetaxel 36 mg/ m2 and Lonafarnib 100 mg
Active Comparator
Docetaxel 36 mg/ m^2 Intravenously weekly and Lonafarnib 100 mg by mouth twice a day daily
干预措施: Docetaxel (Drug)
Docetaxel 30 mg/m2 and Lonafarnib 100 mg
Active Comparator
Docetaxel30 mg/m^2 Intravenously weekly and Lonafarnib 100 mg by mouth twice a day daily.
干预措施: Lonafarnib (Drug)
Docetaxel 30 mg/m2 and Lonafarnib 100 mg
Active Comparator
Docetaxel30 mg/m^2 Intravenously weekly and Lonafarnib 100 mg by mouth twice a day daily.
干预措施: Docetaxel (Drug)
结局指标
主要结局
Determine the molecular interaction
时间窗: Four weeks
次要结局
- Determine safety and efficacy(4 Weeks)
研究者
研究点 (1)
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