CTRI/2020/12/029989进行中（未招募）未知
A Randomized, Open-Label, Two Treatment, Two Period, Two Sequence, Steady-State Crossover Bioequivalence Study Of Pazopanib HCL 200 Mg Tablet (4 Tablets X 200 Mg) Of Alembic Pharmaceuticals Limited, India And Votrient (Pazopanib HCL) 200 Mg Tablets (4 Tablets X 200 Mg) Of Novartis Healthcare Pvt. Ltd., India, Administered Under Fasting Conditions In Patients With Advanced Renal Cell Carcinoma (RCC).
试验速览
- 阶段
- 未知
- 状态
- 进行中（未招募）
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1.Male or non-pregnant female patients more than 18 years of age.
- •2.Patient willing to give written informed consent.
- •3.Documented diagnosis (histological confirmation) of advanced RCC patient.
- •4.Patient who are stable on a dose of 800 mg of pazopanib at least for the last 15 days.
- •5.Patient, who in the opinion of the Investigator has a life expectancy greater than or equal to 6 months from the time of the first dose.
- •6.Eastern Cooperative Oncology Group (ECOG) performance status (PS) ââ?°Â¤ 2.
- •7.Patient whose organ and immune system functions are adequate as indicated by the following laboratory values or considered by the Investigator/sub-Investigator to be of no clinical significance.
- •Hematologic:
- •Absolute neutrophil count (ANC)ââ?°Â¥ 1.5 X 109/L
- •Plateletsââ?°Â¥ 100 X 109/L
- •Hemoglobinââ?°Â¥ 9.0 g/dL
- •Prothrombin Time (PT)ââ?°Â¤ 1.2 X ULN
- •International Normalized Ratio (INR)ââ?°Â¤ 1.2 X ULN
- •activated Partial Thromboplastin Time (aPTT)ââ?°Â¤ 1.2 X ULN
- •Total bilirubinââ?°Â¤ 1.5 X ULN
- •AST and ALTââ?°Â¤ 2.0 X ULN
- •Serum creatinineââ?°Â¤ 2 mg/dL
- •Creatinine clearanceââ?°Â¥ 30 mL/min
- •8. Patient with cardiac ejection fraction within the normal range as measured by echocardiogram.
- •9.The patient must have a clinically acceptable 12-lead ECG at screening including QTc interval ââ?°Â¤ 480 msec.
- •10.Patient must have clinically acceptable results for all the screening parameters and investigations.
- •11.Able to swallow and retain orally administered medication.
- •12.Availability of patient for the entire study duration and willingness to adhere to protocol requirements as evidenced by written informed consent.
- •13.Female patient
- •a) of childbearing potential practicing an acceptable method of birth control such as sexual abstinence, (other than hormonal contraceptives) e.g. barrier method (diaphragm, condom, etc.); for the duration of the study as judged by the investigator(s)/study physician and agree to follow the same during treatment and for at least one week after their study participation is complete. The patient agrees to accept the risk that pregnancy could still result despite using birth control devices. OR
- •b) Postmenopausal for at least the past 12 months. OR
- •c) Surgically sterile (bilateral tubal ligation/bilateral oophorectomy/hysterectomy has been performed on the patient).
- •14.Male patient must agree to practice an acceptable method of birth control such as sexual abstinence, a barrier method of contraception (i.e. condom) for the duration of the study as judged by the investigator(s)/study physician and agree to follow the same treatment and for at least one week after treatment discontinuation of Pazopanib HCL therapy. The patient agrees to accept the risk that pregnancy in a female partner could still result despite using birth control devices
排除标准
- •1. Pregnant and lactating female.
- •2.Patient receiving any medications or substances that are strong inhibitors or inducers of the CYP450 enzyme.
- •3.Receiving any drugs known to prolong the QT interval within 4 weeks before the study or during the study.
- •4.Patient with any hematological, renal, neurological, or liver injury > Grade 3 toxicity during prior systemic therapy regimens.
- •5.Patient with brain metastases as confirmed by Computed Tomography (CT) or Magnetic Resonance Imaging (MRI).
- •6.Patient with clinically significant gastrointestinal abnormalities that may increase the risk for gastrointestinal bleeding including, but not limited to:
- •Ã¢â?¬Â¢Active peptic ulcer disease
- •Ã¢â?¬Â¢Known intraluminal metastatic lesion/s with the risk of bleeding
- •Ã¢â?¬Â¢Inflammatory bowel disease (e.g. ulcerative colitis, Crohnââ?¬•s disease), or other gastrointestinal conditions with increased risk of perforation
- •Ã¢â?¬Â¢History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 28 days before study treatment
- •Ã¢â?¬Â¢Malabsorption syndrome
- •Ã¢â?¬Â¢Major resection of the stomach or small bowel.
- •7.Any other significant medical comorbidities or intercurrent illnesses or infection may have an impact on patient safety and do not permit the dosing of Pazopanib HCL as determined by the Investigator.
- •8.Patient with uncontrolled hypertension while receiving appropriate medication (systolic blood pressure ââ?°Â¥ 150 mmHg and diastolic blood pressure ââ?°Â¥ 90 mmHg).
- •9.Patient with hypokalemia, hypomagnesemia, or long QT syndrome.
- •10.History of any one of the following cardiac conditions within the past 6 months;
- •11.Cardiac angioplasty or stenting, myocardial infarction, unstable angina, symptomatic peripheral vascular disease, coronary artery by-pass graft surgery, class III or IV congestive heart failure as (NYHA), serious cardiac arrhythmias, cerebrovascular accident, stroke (including transient ischemic attack), pulmonary embolism or untreated deep venous thrombosis.
- •12.Evidence of bleeding diathesis or coagulopathy.
- •13.Anticoagulant treatment with curative intent.
- •14.Alcohol dependence, alcohol abuse, or drug abuse or addiction with any recreational drug within the past year.
- •15.Patient who have consumed grapefruit, citrus fruits, and its products for 48 hours before first dosing or during the study.
- •16.Patient who have consumed any xanthine containing items (i.e. tea, coffee, cola drinks, or chocolate/coca, etc.) for 48 hours before first dosing or during the study.
- •17.Allergy or significant history of hypersensitivity or idiosyncratic reactions to study drug product or its excipients etc.
- •18.History of difficulty in swallowing.
- •19.Clinically assessed as having inadequate venous access for PK sampling.
- •20.Patient deemed uncooperative or non-compliant.
- •21.Patient who have shown positive results in urine alcohol test and/or urine drug screening test.
- •22.Significant abnormal 12 lead ECG, X-ray, and 2D-Echocardiography finding.
- •23.A positive result of HIV, HCV, RPR, and HBsAg.
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