EUCTR2012-002122-67-BE进行中（未招募）1 期
Phase II randomized comparative trial of TAK-700 (Orteronel) versus bicalutamide in metastatic prostate cancer patients failing 1st line treatment with LHRH analogs or surgical castration.
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- EORTC
- 入组人数
- 200
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Male
入选标准
- •Histologically confirmed diagnosis of prostate adenocarcinoma
- •Metastatic disease in bone or other lesions documented by imaging. Abnormal 99mTc-bone scan imaging must be confirmed by Computed Tomography (CT) Scan or Magnetic resonance Imaging (MRI)
- •Progressive disease following 1st line androgen deprivation therapy with LHRH (luteinizing hormone-releasing hormone) analogs or surgical castration. Recommendations of Prostate Cancer Working Group 2 (PCWG2)
- •WHO (World health organization) performance status = 2
- •Life expectancy > 12 weeks
- •Adequate bone marrow function (Absolute neutrophil count (ANC) 1500/µL; platelets 100,000/µL)
- •Castrate serum levels of testosterone (< 50 ng/dL)
- •Adequate renal function: calculated creatinine clearance > 40 mL/minute
- •Adequate hepatic function:
- •?Bilirubin: total bilirubin 1.5 Upper limit of Normal (ULN)
- •?Asparate aminotransferase (AST) and/or Alanine aminotransferase (ALT) = 2.5 x ULN in the absence of liver metastases or = 5 x ULN if liver metastases are present
- •Patients of reproductive potential should use adequate birth control measures, as defined by the investigator, during the study treatment period and for at least 4 months following the last study treatment. A highly effective method of birth control is defined as those that result in low failure rate (i.e. less than 1% per year) when used consistently and correctly
- •Before patient registration/randomization, written informed consent must be given according to ICH/GCP (International conference on Harmonization-Good Clinical Practices), and national/local regulations
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 100
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 100
排除标准
- •Cardiac function:
- •?Screening calculated ejection fraction (Multi Gated Acquisition Scan (MUGA) scan, or by echocardiogram) must be = 50%
- •?No history of myocardial infarction, unstable symptomatic ischemic heart disease, ongoing arrhythmias of Grade > 2 thromboembolic events (e.g., deep vein thrombosis, pulmonary embolism, or symptomatic cerebrovascular events), or any other cardiac condition (e.g., pericardial effusion restrictive cardiomyopathy) within 6 months prior to first dose of study drug
- •?Chronic stable atrial fibrillation on stable anticoagulant therapy is allowed
- •?Absence of New York Heart Association Class III or IV heart failure
- •?Absence of Electrocardiogram (ECG) abnormalities of: Q-wave infarction, unless identified 6 or more months prior to screening and QTc interval > 470 msec
- •?No uncontrolled hypertension despite appropriate medical therapy defined as blood pressure >160/90 mmHg at 2 separate measurements no more than 60 minutes apart during the Screening visit
- •Prior radiotherapy but only for lymph nodes is allowed
- •Prior or concomitant therapy:
- •?No intake of narcotic analgesia for bone pain
- •?No prior treatment with non-steroidal antiandrogens, within 6 months prior to randomization
- •?No anticancer therapy or treatment with another investigational agent within the last 4 weeks prior to randomization
- •?No prior therapy with TAK-700, ketoconazole, abiraterone, aminoglutethimide or MDV3100
- •?Patients taking bisphosphonates or denosumab are eligible if they have received a stable dose for 4 weeks or more prior to randomization. (These treatments may then be continued on study)
- •No known hypersensitivity to compounds related to TAK-700 or to TAK-700 excipients (refer to Investigator's brochure)
- •No known gastrointestinal (GI) disease or GI procedure that could interfere with the GI absorption or tolerance of TAK-700, including difficulty swallowing tablets
- •No prior history of adrenal insufficiency
- •No prior history of malignancies other than prostate adenocarcinoma (except for basal cell or squamous cell carcinoma of the skin), or the patient has been free of malignancy for a period of 3 years prior to first dose of study drug
- •No known active chronic hepatitis B or C, life-threatening illness unrelated to cancer, or any serious medical or psychiatric illness that could, in the investigator's opinion, potentially interfere with participation in this study
- •No drug or alcohol abuse
- •Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial
研究者
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