CTRI/2018/07/014859已完成未知
Effect of food on pharmacokinetics of abiraterone in metastatic castration resistant prostate cancer patients
All India Institute of Medical Sciences New Delhi0 个研究点目标入组 18 人开始时间: 待定最近更新:
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 18
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Ba/be
入排标准
入选标准
- •1.Patients in age >=18 years
- •2.Patients with histologically confirmed adenocarcinoma of the prostate
- •3.Patients with metastatic disease based on a positive bone scan or objective imaging on CT scan
- •4.mCRPC patients (defined as disease progression despite androgen deprivation therapy i.e., either a luteinizing hormone-releasing hormone agonist or bilateral orchiectomy) who are taking abiraterone 1000 mg for a minimum period of one month.
排除标准
- •1.Patients who are not willing to participate and will not provide signed informed consent
- •2.Uncontrolled DM, defined as HbA1c >=7.5%
- •3.Patients with hepatic dysfunction that is those in whom serum bilirubin will be more than 1.5 and, AST and ALT will be more than 2.5 fold higher than the upper limit of normal at baseline
- •4.Patients in whom serum creatinine will be more than 1.5 fold higher than the upper limit of normal
- •5.Patients with serum potassium less than 3.5 mEq/dl
- •6.Patients taking CYP3A4 inhibitors (ketoconazole, itraconazole, clarithromycin, atazanavir, nefazodone, saquinavir, telithromycin, ritonavir, indinavir, nelfinavir, voriconazole) or inducers (e.g., phenytoin, carbamazepine, rifampin, rifabutin, rifapentine, phenobarbital) available from Metabolism and Transport Drug Interaction Database (http://www.druginteractioninfo.org)
- •7.Patients taking drugs which are substrates of CYP2D6 (dextromethorphan, thioridazine) available from Metabolism and Transport Drug Interaction Database (http://www.druginteractioninfo.org)
- •8.Autoimmune disease requiring corticosteroid therapy. Active infection or other medical condition that would contraindicate the use of prednisone/prednisolone (corticosteroid)
- •9.Uncontrolled hypertension (systolic BP >= 160 mmHg or diastolic BP >= 95 mmHg) Patients with a history of hypertension are allowed provided blood pressure is controlled by anti-hypertensive treatment
- •10.Clinically significant heart disease as evidenced by myocardial infarction, or arterial thrombotic events in the past 6 months, severe or unstable angina, or New York Heart Association (NYHA) Class II-IV heart disease
- •11.Atrial Fibrillation, or other cardiac arrhythmia requiring medical therapy
- •12.Administration of an investigational therapeutic agent within 30 days of screening
- •13.Prior radiation therapy completed < 4 weeks prior to enrollment
- •14.Prior chemotherapy for castration resistant prostate cancer. Patients who have received chemotherapy for early stage prostate cancer (e.g., as part of a neoadjuvant or adjuvant trial) or for other malignancies are eligible provided that >1 year has passed since the administration of the last chemotherapy dose
- •15.Any currently active second malignancy. Patients are not considered to have a currently active malignancy, if they have completed therapy and are considered by their physician to be at least less than 30% risk of relapse over next year
- •16.Active psychiatric illnesses/social situations that would limit compliance with protocol requirements
- •17.Patients in whom urgent chemotherapy, in the opinion of the treating physician, is indicated
- •18.Thyrotoxicosis patients
- •19.Known brain metastasis
- •20.History of pituitary or adrenal dysfunction
- •21.Patients with BMI 18.5 â?? 27.4 kg/m2
- •22.Patients with lactose intolerance or allergy to milk protein
研究者
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