NCT00629525已完成2 期
A Single Arm, Two Center, Phase II Study of RAD001 in Patients With Metastatic, Hormone-Refractory Prostate Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- Biochemical Response Rate
研究概览
简要总结
The purpose of this study is to determine the biochemical response rate (PSA) to single agent RAD001 in patients with metastatic hormone-refractory prostate cancer (HRPC).
详细描述
This is a single center, Phase II study of RAD001 in men with HRPC. The study design is a straight forward, two-stage design with tumor biopsies scheduled at screening and again at 4 weeks. FLT-PET scans are performed at screening and again at day 28, following initiation of treatment in the first 10 patients. Patients are assessed for adverse events every two weeks for the first month and monthly thereafter. Patients are assessed for response by PSA every 4 weeks and when applicable, for objective response every 2 months. If 4 or more responses are seen in the first 39 patients then the study will expand to 60 patients.
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
- Male
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed diagnosis of adenocarcinoma of the prostate
- •Clinical or radiographic evidence of metastatic disease
- •ADT using LHRH agonist (eg leuprolide, goserelin) must continue on therapy. However, ketoconazole, estrogens, and all other forms of hormonal manipulation are not permitted on study.
- •Evidence of disease progression on ADT as evidenced by:
- •2 consecutive PSA levels 50% or greater above the PSA nadir achieved on ADT and separated at least 1 week apart, or
- •Radiographic evidence of disease progression defined by RECIST criteria and compared to prior studies on ADT.
- •A minimum of 6 weeks has elapsed off of anti-androgen therapy without withdrawal response.
- •A minimum of 4 weeks from any prior radiation therapy, surgery, chemotherapy or other investigational agent
- •Biopsies will not be performed if platelet counts < 75,000/ ul, PTT, PT or INR > 1.4 times control
- •Patients must have normal organ and marrow function as defined below:
- •hemoglobin > 9.0g/dL
- •absolute neutrophil count > 1,500/μl
- •platelets > 100,000/μl
- •total bilirubin < 1.5 X upper limit of normal (ULN)
- •AST(SGOT)/ALT(SGPT) < 2.5 X ULN
- •creatinine < 1.5 X ULN
- •total fasting cholesterol < 350
- •total triglycerides < 300
- •Patients on antilipid therapy may participate in this study.
- •Age > 18 years
- •ECOG performance status 0 or 1
- •Ability to swallow and retain oral medication
- •Ability to understand and the willingness to sign a written informed consent document.
排除标准
- •History of solid organ or stem cell transplantation
- •Also, no current use of chronic immunosuppressive therapy is allowed
- •Patients with known brain metastases (or history of brain metastases)
- •History of HIV, hepatitis B, or hepatitis C infection
- •Patients who have received investigational, biologic, hormonal (other than ADT), immunotherapy, or chemotherapy less than 4 weeks prior to entry on this study or have not recovered from the toxic effects of such therapy
- •Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection (requiring antifungal, antibiotic or antiviral therapy), symptomatic congestive heart failure (NYHC III or greater), unstable angina pectoris, cardiac arrhythmia (uncontrolled SVT or any VT), or psychiatric illness/social situations that would limit compliance with study requirements
- •History of malabsorption syndrome, disease significantly affecting gastrointestinal function or major resection of the stomach or small bowel that could affect absorption, distribution, metabolism or excretion of study drugs.
- •Any unresolved bowel obstruction or diarrhea
研究组 & 干预措施
RAD001
Experimental
RAD001 at a dose of 10 mg PO daily
干预措施: RAD001 (Drug)
结局指标
主要结局
Biochemical Response Rate
时间窗: Patients were followed for a median of 315 days
Number of participants with 50% decline in serum PSA from baseline was pre-set as the primary measure of disease response.
次要结局
- Progression Free Survival(Patients were followed for a median of 315 days, with the last patient censored at 1309 days.)
- Molecular Response(Patients were followed for a median of 315 days)
- Pathologic Response(Patients were followed for a median of 315 days)
- Clinical Response(Patients were followed for a median of 315 days)
研究者
Daniel George, MD
Associate Professor of Medicine
Duke University
研究点 (1)
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