PER-142-08已完成未知
A Phase II Randomized, Placebo Controlled Clinical Trial to Study the Efficacy and Safety of Bicalutamide With or Without Deforolimus (Ridaforolimus) in Men With Asymptomatic, Metastatic Castrate-resistant Prostate Cancer
MERCK SHARP & DOHME PERU S.R.L.,0 个研究点目标入组 0 人开始时间: 2009年1月9日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 90（—）
- 性别
- Male
入选标准
- •The patient has histologically confirmed adenocarcinomas of the prostate.
- •Pathological archival material is available for delivery to the central laboratory.
- •The patient presents evidence of metastatic disease upon entering the protocol or at the time of the previous hormonal treatment, determined radiographically through the presence of at least 2 bone examination lesions consistent with metastases or abdominal / pelvic lymph nodes> 2 cm in the longest axial measurement. Unique or ambiguous bone lesions should be confirmed with simple radiographs or magnetic resonance imaging (MRJ).
- •The patient presents evidence of disease progression despite levels of castration of testosterone (<50 ng / dl) after an orchiectomy or during therapy with an agonist or antagonist of the luteinizing hormone releasing hormone (LHRH) ) (with or without an antiandrogen).
- •The patient has a PSA> 10 ng / ml.
- •A minimum of four weeks has elapsed between previous surgery or radiotherapy (limited to no more than 25 percent of the bone marrow) and enrollment.
- •The patient maintains therapy with an LHRH agonist or antagonist throughout the study, or has undergone a bilateral orchiectomy.
- •The patient has a general status <1 on the General State Scale according to the Eastern Oncology Cooperative Group (ECOG).
- •The patient agreed to participate voluntarily by providing written informed consent.
- •The patient is> 18 years of age on the day of signing the informed consent.
- •Patients who are not surgically sterile should use a reliable contraceptive method from the time of selection until 30 days after the last dose of the study drug.
- •The patient has an adequate organic function as indicated by laboratory values
排除标准
- •The patient has received bicalutamide, flutamide or nilutamide within the last 12 months.
- •The patient has previously received chemotherapy for metastatic prostate cancer.
- •The patient is currently participating or has participated in a study with a compound or device under investigation within 30 days of the initial dose administration of the study drug.
- •The patient has previously received rapamycin or rapamycin analogues, such as deforolimus, temsirolimus or everolimus.
- •The patient is receiving corticosteroids administered at higher doses than those used for normal replacement therapy.
- •The patient is receiving a narcotic opioid or analgesic prescribed for pain due to prostate cancer.
- •In the opinion of the researcher, the patient suffers from pain related to metastatic prostate cancer that justifies the beginning of chemotherapy.
- •The patient has a history of anterior malignancy as a primary tumor of the central nervous system, with the following exception: cutaneous basal cell carcinoma; or any patient who has undergone a potentially curative therapy without evidence of said disease for five years, or who is considered by their attending physician to have a low risk of recurrence.
- •The patient has some metastatic visceral disease such as malignant pleural effusions or ascites, current or previously treated epidural disease, active or treated CNS metastases, and / or carcinomatous meningitis. Exception: patients with treated epidural lesions and no other epidural evolution are eligible to enter the study.
- •The patient has known hypersensitivity to macrolide antibiotics (ie: clarithromycin, erythromycin or azithromycin); or bicalutamide.
- •The patient has Class III or IV congestive heart failure according to the New York Heart Association or any other significant history of heart disease such as: myocardial infarction within the last 6 months ; ventricular arrhythmia or acute congestive heart failure within the last 3 months; uncontrolled angina or uncontrolled hypertension.
- •The patient has recently diagnosed Type 1 or 2 diabetes (within 3 months prior to enrollment) or poorly controlled.
- •The patient has an active infection that requires prescription intervention.
- •The patient is known to be positive for the human immunodeficiency virus (HIV).
- •The patient has a known history of Hepatitis B or C.
- •The patient has known psychiatric or substance abuse disorders that could interfere with the cooperation with the test requirements.
- •The patient is, at the time of signing the informed consent, a regular user (including recreational use) of any illicit drug or has a recent history (within the last year) of drug addiction or alcoholism.
- •The patient has not adequately recovered from any previous surgical procedure or has undergone a major surgical procedure within 2 weeks prior to the first dose of the study drug (patients who have undergone the recent placement of a central venous access path will be considered eligible if they have been fully recovered.)
- •The patient has a current history or evidence of any laboratory condition, therapy or abnormality that could confuse the results of the study or interfere with the patient´s participation throughout the study, or it is not convenient for the patient to participate.
- •The patient requires concurrent treatment with drugs that are strong inducers or inhibitors of cytochrome P450 (CYP3A). P
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