CTRI/2018/01/011386已完成1 期
A randomized, open label, multi-center, two-treatment, two-period, two-sequence, two-waycross-over, multiple dose, steady state Bioequivalence (BE) study of Genus Lifesciences Inc.Nilutamide Tablets 150 mg with NILANDRON® (Nilutamide) Tablets 150 mg from ConcordiaPharmaceuticals Inc. in metastatic prostate cancer patients. - NLM101
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 40
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
- •The patients will be enrolled in the study based on the following inclusion criteria:
- •a) Male Patient aged 18 to 75 years having Body Mass Index (BMI) at least 17 calculated as weight in kg/height in m2
- •b) Patients with biopsy confirmed prostate cancer (Stage D2)
- •c) Patients who are already receiving 150mg of Nilutamide once a day as their individual therapy for at least 15 days prior to randomization.
- •d) Able to swallow and retain oral medication
- •e) Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 2
- •f) Life expectancy of Greater Than 180 days.
- •g) Acceptable hematology status:
- •Hemoglobin greater than or equal to 9 g/dL
- •Absolute neutrophil count (ANC) greater than or equal to 1500 cells/µL
- •Platelet count greater than or equal to 1,00,000 cells/µL
- •h) Acceptable liver function:
- •Alanine aminotransferase (ALT) less than or equal to 2X upper limit of normal (ULN)
- •Aspartate aminotransferase (AST) less than or equal to 2X ULN
- •Bilirubin less than 1.2 mg/dL
- •Alkaline phosphatase less than or equal to 5X ULN
- •i) Acceptable kidney function
- •Creatinine less than or equal to 2X ULN or
- •Creatinine clearance greater than or equal to 60 mL/minute
- •j) Willing and able to provide written informed consent prior to any study-related activities being performed.
- •k) No history of addiction to any recreational drug or drug dependence or alcohol addiction.
排除标准
- •The patients will be excluded from the study based on the following exclusion criteria:
- •a) Hypersensitivity to utamide or to any of the excipients.
- •b) History of major respiratory, cardiac (New York Heart Association [NYHA] Type III or IV), liver, or kidney disease.
- •c) Known hypersensitivity, idiosyncratic, or allergic reactions
- •d) In patients with severe leukopenia, neutropenia, or thrombocytopenia,
- •e) Active opportunistic infection with mycobacteria, cytomegalovirus, toxoplasma, Pneumocystis carinii, or other microorganism.
- •f) Major surgical procedure (including periodontal) within 28 days of first dose of Investigational Product.
- •g) Surgical or other non-healing wounds.
- •h) Exposure to any investigational agent within 12 weeks prior to first dose of Investigational Product.
- •i) History of other malignancies in the last 5 years. Potential patients with prior history of in situ cancer or basal or squamous cell skin cancer are eligible. Potential patients with other malignancies that were cured with definitive primary therapy alone (e.g., surgery) and who have been continuously free of the previous disease for 1 year are also eligible upon Sponsor approval.
- •j) Severe or life-threatening infection, including known past medical history of human immunodeficiency virus/acquired immune deficiency syndrome (HIV/AIDS).
- •k) Has not recovered to Grade 0 or 1 toxicity from previous anticancer treatments or previous investigational agents. Exceptions are alopecia (any grade is acceptable), fatigue (Grade 2 is acceptable), and peripheral neuropathy (stable Grade 2 is acceptable) (Per National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE], v4.03).
- •l) Uncontrolled diabetes mellitus.
- •m) Any other medical condition or serious intercurrent illness that, in the opinion of the Investigator, may make it undesirable for the patient to participate in the study including but not limited to cirrhosis or psychiatric illness/social situations that would limit adherence to study requirements.
- •n) Any other condition(s) which could significantly interfere with Protocol compliance including, but not limited to, dementia, psychosis, cognitive impairment, altered mental status, or other major psychiatric disorder.
- •o) Donation and/or loss of 350 ml (1 unit) of blood within 90 days prior to fist dose administration of investigational product.
- •p) Positive hepatitis screening laboratory tests for hepatitis B, and/or hepatitis C.
- •q) Patients receiving warfarin-type anticoagulants, phenytoin, propranolol, chlordiazepoxide, lidocaine, diazepam and theophylline
研究者
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