CTRI/2021/03/031750已完成1 期
A Multicentric Open label Randomized Two Period Two Treatment Two Sequence Crossover Multiple Dose Steady state Bioequivalence Study of Sunitinib Malate Capsules 50 mg of Eugia Pharma Specialities Limited India with Sutent capsules 50 mg of Pfizer Labs USA in adult patients with advanced renal cell carcinoma already receiving stable dose of Sunitinib Malate Capsules 50 mg under fasting conditions
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 48
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
- •Male and or female patient of age in between 18 years to 65 years (both inclusive)
- •Patient with confirmed diagnosis of advanced renal cell carcinoma (histological or radiological)
- •Patient who are already receiving a stable dose of Sunitinib Malate Capsules 50 mg once daily as per investigators discretion for at least 14 days at screening
- •Patient with ECOG (Eastern Cooperative Oncology Group) performance status 0 2
- •Patient with estimated life expectancy greater than equal to 3 months
- •Patient should have no clinically significant abnormality in any of the laboratory parameters including ECG and Chest X ray as per the discretion of Principal Investigator at screening only
- •Patient with no persistent toxicities from prior medications Recovery to baseline or lesser tha equal to Grade 1 CTCAE v 5 0 or higher and or stable on supportive therapy at screening visit if any toxicities had occurred unless the toxicities were clinically insignificant
- •Patient with adequate organ and bone marrow function based upon the following laboratory criteria at the time of screening
- •Hemoglobin greater than equal to 9 g per dL
- •Absolute neutrophil count greater than equal to 1500 per uL
- •Platelet count greater than equal to 100000 per uL
- •Creatinine lesser than 2 x ULN
- •Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) lesser than 2.5 x upper limit of normal
- •Total bilirubin within lesser than equal to 1.5 x upper limit of normal
- •Clinically insignificant fasting serum glucose levels, S. blood urea nitrogen (BUN) and Urine protein levels
- •Patient and/or Legally Acceptable Representative had given consent after being advised of the nature and risks of the study
- •Female patient of childbearing potential must have a negative serum pregnancy test at screening
- •Females must use acceptable and effective methods of contraception during the study conduct and up to 8 weeks after last does of study drug such as the following:
- •Tubal sterilization (tubal ligation performed more than one month before Study Day 1 transcervical tubal occlusion procedure performed more than six months before Study Day 1)
- •Intrauterine Device (IUD)
- •Progestin Implant (i e Implanon or its equivalent)
- •Progestin injection or progestin oral contraceptive pill and one barrier method (cervical cap diaphragm, contraceptive sponge or vaginal spermicide and a male or female condom)
- •Two barrier methods used together (cervical cap, diaphragm contraceptive sponge, or vaginal spermicide and a male or female condom)
- •Absolute sexual abstinence (no sexual intercourse or genital contact with a male partner) during the study conduct
- •Male patient must agree to use an effective method of contraception from screening during study and up to 8 weeks after the last dose of study drug
- •Patient willing to and able to comply with the protocol
排除标准
- •Patient who are hypersensitive to Sunitinib and its excipients
- •Patient with hypertension (BP greater than equal to 150 per 100 mm of Hg even after use of more than 1 antihypertensive medication) and cardiac risk factors (e g known congestive heart failure low left ventricular ejection fraction or prolonged QT interval)
- •Patient with hepatic or renal dysfunction as per Investigators Discretion
- •Patient with diagnosis of any second malignancy within the last 5 years except for adequately treated basal cell or squamous cell skin cancer or in situ carcinoma of the cervix uteri
- •Patient with history of or known brain metastases, spinal cord compression, or carcinomatous meningitis or past history of brain or leptomeningeal disease
- •Patient with history of pre-existing thyroid abnormality with thyroid function that cannot be maintained in the normal range with medication
- •Patient with major surgery or radiation therapy lesser than 4 weeks of starting the study treatment
- •Patient with severe acute or chronic medical psychiatric condition that could have increased the risk associated with study participation study drug administration or interpretation of study results in the judgment of the investigator
- •Patient who require invasive dental procedures
- •Patient with uncontrolled diabetes as per investigators discretion
- •Patient with history of arterial thrombosis or deep vein thrombosis within the past 12 months
- •Patient within the 6 months prior to study drug administration
- •severe unstable angina
- •symptomatic congestive heart failure or
- •cerebrovascular accident
- •Patient with ongoing cardiac dysrhythmias:
- •atrial fibrillation of any grade or
- •QTc interval prolongation to lesser than 500 msec for males or lesser than 470 msec for females
- •Patient with positive test for hepatitis B surface antigen hepatitis C antibody or human immunodeficiency virus (HIV) 1 and 2 serological test at screening or has been previously treated for hepatitis B hepatitis C or HIV infection
- •Patient with positive test for urine drugs of abuse and or alcohol breath test
- •Patient with history of noncompliance to medical regimens
- •Patient with history of alcoholism alcohol abuse
- •Patient with history of difficulty with donating blood or difficulty in accessibility of veins
- •Patient for whom oral administration of drug is not possible
- •Patient with an unusual or abnormal diet for whatever reason within 48 hours prior to check in e g religious fasting
- •Consumption of grapefruit mosumbi sweet lime juice within 48 hours prior to study check in and for the entire period of study
- •Patient donated blood (1 unit or 350 ml) within 90 days prior to receiving the first dose of investigational medicinal product in the study
- •Patient participated in another clinical trial in the last 60 days
- •Pregnant and lactating females
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