EUCTR2011-002965-39-GB进行中（未招募）1 期
Orteronel maintenance therapy in patients with metastatic castration resistant prostate cancer and non-progressive disease after first-line docetaxel therapy: A multicenter randomized double-blind placebo-controlled phase III trial. - SAKK08/11
Swiss Group for Clinical Cancer Research (SAKK)0 个研究点目标入组 47 人开始时间: 2013年3月13日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 47
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
入选标准
- •Patient has given voluntary written informed consent before performance of any study related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care
- •Male patient 18 years or older
- •WHO performance status of =2 (see Appendix 3)
- •Adenocarcinoma of the prostate, histologically or cytologically confirmed
- •Castration resistance: tumour progression after orchiectomy or during treatment with GnRH analogues (agonists or antagonists)
- •Metastatic disease, radiographically documented (CT/MRI, bone scan)
- •Total testosterone = 50 ng/dL (= 1.7 nmol/L)
- •Non-progressive disease after docetaxel first-line treatment with a cumulative dose = 300mg/m2
- •No evidence of progression on imaging according to PCWG2 and modified RECIST 1.1 criteria
- •PSA levels not elevated = 25% AND at least 2 ng/mL above the nadir since start of docetaxel treatment
- •Non-surgically castrated patient agrees on ongoing use of GnRH analogues (agonists or antagonists) during the trial
- •Laboratory values as specified below:
- •PSA = 2 ng/mL
- •Potassium = 3.5 mmol/L
- •Absolute neutrophil count (ANC) = 1.5 x 10 9/L and platelet count = 100 x 10 9/L
- •Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) = 2.5 x ULN
- •Total bilirubin = 1.5 x ULN (except for patient with Gilbert’s disease)
- •Estimated creatinine clearance using the Cockcroft-Gault formula ? 40 mL/minute
- •Planned start of trial treatment 3 to 6 weeks after last docetaxel administration
- •Screening calculated ejection fraction of = 50% or normal according to local standard by echocardiogram or by multiple gated acquisition (MUGA) scan.
- •Baseline QL questionnaire completed
- •Patient is able and willing to swallow study drug as whole tablet
- •Patient compliance and geographic proximity allow proper staging and follow-up
- •Patient, even if surgically sterilized (i.e., status post vasectomy)agrees to practice effective barrier contraception during the entire study treatment period and for 4 months after the last dose of study drug, or agrees to completely abstain from intercourse
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •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 92
排除标准
- •Prior therapy with aminoglutethimide, ketoconazole, orteronel, abiraterone or other modern CYP17 inhibitors
- •Prior chemotherapy for prostate cancer within 12 months before enrollment except from docetaxel
- •Retreatment with docetaxel after interruption of > 5 weeks
- •Concurrent disease requiring higher doses of corticosteroid than the equivalent of 10 mg prednisone per day
- •Known hypersensitivity to trial drug or hypersensitivity to any of its components
- •Patient has received other investigational drugs within 30 days before enrollment
- •Presence of a small cell component in histological specimen
- •Radiotherapy within the last 2 weeks before expected start of the trial treatment
- •Known history of central nervous system (CNS) or spinal cord metastases
- •Current spinal cord compression
- •Diagnosed or treated for another malignancy within 2 years of registration, with the exception of complete resection of basal cell carcinoma or squamous cell carcinoma of the skin, or any in situ malignancies
- •History of myocardial infarction, unstable symptomatic ischemic heart disease, ongoing arrhythmias of Grade = 3 (NCI CTCAE version 4.0) or thromboembolic events (e.g., deep vein thrombosis, pulmonary embolism, or symptomatic cerebrovascular events) within 6 months prior to first dose of study drug. Chronic stable atrial fibrillation on stable anticoagulant therapy is allowed
- •New York Heart Association Class III or IV heart failure
- •ECG abnormalities of:
- •Q-wave infarction, unless identified = 6 months prior to registration
- •QTc interval > 460 msec
- •Uncontrolled hypertension despite appropriate medical therapy (blood pressure (BP) of greater than 160 mmHg systolic AND 90 mmHg diastolic at 2 separate measurements no more than 60 minutes apart during the pretreatment evaluation). Note: patients may be rescreened after adjustment of antihypertensive medications.
- •Likely inability (e.g. due to a psychiatric disorder) to understand information on trial related topics, to give informed consent, to comply with the protocol, to fill in Quality of Life forms and to cooperate fully with the investigator and site personnel
- •Known gastrointestinal (GI) disease or GI procedure that could interfere with the GI absorption or tolerance of orteronel
- •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
研究者
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