CTRI/2018/08/015335已完成1 期
A Multicentric Open Label Randomized Two Treatment Two-sequence Two period Cross-over Multiple dose, Steady-state Clinical Bioequivalence Study of Everolimus 10 mg tablets of Eugia Pharma Specialities Limited India A Joint venture of Aurobindo Pharma Limited and Celon Laboratories Limited Test with Afinitor® Everolimus 10 mg tablets of Novartis Pharmaceuticals Corporation USA Reference in advanced renal cell carcinoma patients under fasting conditions - RCC
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 45
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.Male and females of age in between 18 years to 65 years (both inclusive).
- •2.Ability to provide informed consent prior to participation in the study by patient/LAR
- •3.Confirmed diagnosis of advanced renal cell carcinoma.
- •4.Who are already receiving a stable dose of Everolimus tablets, 10 mg tablet once daily as per investigatorâ??s discretion for at least 14 days at first dosing of study drug.
- •5.Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
- •6.Estimated life expectancy >= 3 months.
- •7.No persistent toxicities from prior medications [Recovery to baseline or <= Grade 1 CTCAE v.4.03 (or) higher and/or stable on supportive therapy at screening visit if any toxicities had occurred unless the toxicities were clinically insignificant]
- •8.Adequate organ and bone marrow function based upon the following laboratory criteria within 7 days before randomization:
- •a.Hemoglobin >=9.0 g/dL
- •b.Absolute neutrophil count >=1500/uL
- •c.Platelet count >=100,000/uL
- •d.Creatinine < 1.5 x ULN
- •e.Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) < 2.5 Ã? upper limit of normal.
- •f.Total bilirubin within <= 1.5 Ã? upper limit of normal.
- •g.Clinically insignificant fasting serum glucose levels, S. blood urea nitrogen (BUN) and Urine protein levels.
- •9.Patient having negative urine screen for drugs of abuse
- •10.Patient having negative breath alcohol test
- •11.Sexually active women, unless surgically sterile (at least 6 months prior to study drug administration) or postmenopausal for at least 12 consecutive months, must agree to use effective methods of avoiding pregnancy from screening, during study and up to 8 weeks after the last dose of study drug.
- •12.Females must use acceptable and effective methods of contraception such as the following:
- •Tubal sterilization (tubal ligation performed more than one month before Study Day1 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 + one barrier method (cervical cap, diaphragm, contraceptive sponge, or vaginal spermicide + a male or female condom)
- •Two barrier methods used together (cervical cap, diaphragm contraceptive sponge, or vaginal spermicide + a male or female condom)
- •Absolute sexual abstinence (no sexual intercourse or genital contact with a male partner)
- •13.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.
- •14.Clinically insignificant laboratory values at screening
- •15.Patients willing to and able to comply with the protocol
排除标准
- •1.Known hypersensitivity to rapamycin, temsirolimus, everolimus or any excipient of everolimus.
- •2.Any prior treatment with everolimus resulting in unacceptable toxicity.
- •3.Receipt of any type of small molecule kinase inhibitors (i.e. axitinib, pazopanib, sorafenib, sunitinib etc) within 2 weeks before randomization.
- •4.Patients with renal failure, hepatic failure or for whom the need for dose change during the study can be anticipated.
- •5.Radiation therapy for bone metastasis within 2 weeks, any other external radiation therapy within 4 weeks before randomization.
- •6.Patients on active treatment with strong, moderate inhibitors or strong inducers of P-glycoprotein and CYP3A4[a minimal of 2 weeks or 5 half- lives wash-out period(whichever is earlier) recommended after stopping such medications].
- •7.History of brain metastasis, spinal cord compression
- •8.Systemic treatment with radionuclides within 6 weeks before randomization or with clinically relevant persistent complications from prior radiation therapy.
- •9.Concomitant anticoagulation at therapeutic doses with oral anticoagulants or platelet inhibitors [Low-dose aspirin and low-dose warfarin ( < 1 mg/day), are permitted]. Anticoagulation with low molecular weight heparin (LMWH) is allowed if on a stable dose for at least 2 weeks before randomization.
- •10.Uncontrolled, significant inter-current or recent illness including, but not limited to
- •a.Cardiovascular disorders:
- •i.Symptomatic congestive heart failure, unstable angina pectoris, serious cardiac arrhythmias.
- •ii.Uncontrolled hypertension defined as sustained BP 150 mm Hg systolic or > 100 mm Hg diastolic despite optimal antihypertensive treatment.
- •iii.Stroke (including TIA), myocardial infarction, within 6 months before randomization.
- •b.Gastrointestinal (GI) disorders including those associated with a high risk of perforation or fistula formation:
- •i. Active peptic ulcer disease, inflammatory bowel disease, diverticulitis, cholecystitis, symptomatic cholangitis or appendicitis, acute pancreatitis or acute obstruction of the pancreatic or biliary duct, or gastric outlet obstruction.
- •ii. Abdominal fistula, gastrointestinal perforation, bowel obstruction, or intra-abdominal abscess within 6 months before randomization. Clinically significant hematuria, hematemesis, or hemoptysis of half teaspoon (2.5 ml) of red blood, or other history of significant bleeding (eg, pulmonary hemorrhage) within 3 months before randomization.
- •c.Cavitating pulmonary lesion(s) or known endobronchial disease manifestation.
- •d.Patient with active infection and symptoms of Non-infectious pneumonitis as judged by the investigator.
- •e.Malabsorption syndrome.
- •f.Serious non-healing wound/ulcer/bone fracture.
- •g.Lesions invading major pulmonary blood vessels.
- •11.In the past 5 years, other prior malignancy (except basal cell carcinoma, squamous cell carcinoma of the skin, or cervical carcinoma in situ).
- •12.Pregnant and lactating females.
- •13.Chronic treatment with corticosteroids or other immunosuppressive agents (with the exception of inhaled or topical corticosteroids or corticosteroids with a daily dosage equivalent <= 10 mg prednisone if given for disorders other than renal cell cancer).
- •14.Positive test for hepatitis B surface antigen, hepatitis C antibody, or human immun
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