NCT00539968终止1 期
An Open-Label, Two-Part Study to Determine the Safety, Tolerability, and Activity of Lonafarnib and Docetaxel
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
- 5
- 主要终点
- Rate of prostate-specific antigen (PSA) responses
研究概览
简要总结
This study will determine the best doses of docetaxel and lonafarnib when the two anti-cancer agents are used in combination. Patients with tumors for which treatment with docetaxel would be appropriate are eligible. A second part of the study will further examine the effectiveness of the combination treatment in men with prostate cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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
- •For Part 1: Subjects may be male or female and must be at least 18 years of age.
- •For Part 1: Cancer for which docetaxel treatment is appropriate.
- •For Part 1: Docetaxel-naïve
- •For Part 2: Subjects must be male and at least 18 years of age.
- •For Part 2: Subjects must have adenocarcinoma of the prostate confirmed by histologic/cytologic biopsy.
- •For Part 2: Subjects must have progressive, metastatic, AIPC and a PSA of 10 ng/ml or more after hormonal therapy prior to docetaxel treatment. Progressive disease is defined as a consistently increasing serum PSA level within 28 days prior to docetaxel administration.
- •Adequate organ function within 3 weeks prior to first study drug administration.
- •Performance status (ECOG) is less than or equal to
- •Subject understands and agrees to procedures and participation by signing informed consent form.
- •Agrees to use medically accepted form of contraception.
排除标准
- •Receipt of or need to continue to receive prohibited medications (listed in the protocol) more recently than the washout period (indicated in the protocol).
- •Surgery within 3 weeks prior to first study drug administration.
- •History within 5 years prior to first study drug administration of another malignancy except adequately treated Stage I/II basal/squamous cell skin cancer.
- •Radiation therapy to more than 25% of his/her total bone marrow during life.
- •Radiation therapy within 3 weeks prior to first study drug administration.
- •Known hypersensitivity to prednisone, docetaxel, polysorbate 80, lonafarnib, or any excipients associated with these medications.
- •Known contraindication to steroid use.
- •Known leptomeningeal or CNS metastasis.
- •Heart, vascular, or seizure disorder (detailed list in the protocol) within 6 months prior to first study drug administration.
- •Baseline QTc interval greater than 450 msec.
- •Grade 2 or more peripheral neuropathy or drug-related toxicity per CTCAE. Exceptions are noted in the protocol.
- •Any clinically significant condition or situation that the investigator thinks would interfere with the study evaluations or subject's participation.
- •Subject is part of staff personnel involved in the study.
- •Subject has known clinically significant immunosuppression.
研究组 & 干预措施
Docetaxel plus lonafarnib (single arm)
Experimental
Docetaxel plus lonafarnib
干预措施: Docetaxel plus lonafarnib (Drug)
结局指标
主要结局
Rate of prostate-specific antigen (PSA) responses
时间窗: Until disease progression, unacceptable dose delays or reductions, or unacceptable toxicity
Incidence of adverse events and dose-limiting toxicities
时间窗: Until disease progression, unacceptable dose delays or reductions, or unacceptable toxicity
次要结局
- Proportion of subjects with dose-limiting toxicities(Until disease progression, unacceptable dose delays or reductions, or unacceptable toxicity)
- Plasma lonafarnib concentrations(Until disease progression, unacceptable dose delays or reductions, or unacceptable toxicity)
- RECIST-defined radiological response rate(Until disease progression, unacceptable dose delays or reductions, or unacceptable toxicity)
研究者
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