Health Condition 1: C649- Malignant neoplasm of unspecifiedkidney, except renal pelvis
Conditions
Interventions
Intervention1: Pazopanib 200 mg tablet of Sun Pharmaceutical Industries Ltd.: Patients will be randomly assigned in a 1:1 ratio to receive either Sun Pharmaceutical Industries Ltd.�s pazopanib
Sponsors
Sun Pharmaceutical Industries Ltd India
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male and non-pregnant female patients aged > 18 years. 2. Ability to provide informed consent prior to participation in the study. 3. Patients with histologically confirmed advanced RCC who are on a stable dose of pazopanib tablets 800 mg once daily, and have received at least fifteen days treatment with 800 mg pazopanib. 4. Estimated life expectancy of greater than or equal to 3 months. 5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 2. 6. No persistent toxicities from prior medications [Recovery to baseline or less than or equal to Grade 1 Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 (or) higher and/or stable on supportive therapy at screening visit if any toxicities had occurred unless the toxicities were clinically insignificant]. 7. Adequate bone marrow function: absolute neutrophil count greater than or equal to 1.5 x 109/L, platelet count greater than or equal to 100 x 109/L, and hemoglobin greater than or equal to 9 g/dL. 8. Adequate liver function: alanine aminotransferase (ALT) / aspartate aminotransferase (AST) less than or equal to 2 x upper limit of normal (ULN) and total bilirubin in the normal values. 9. Adequate coagulation function: prothrombin time or international normalized ratio less than or equal to 1.2 x ULN and activated partial thromboplastin time less than or equal to 1.2 x ULN. 10. Adequate renal function: serum creatinine less than or equal to 1.5 x ULN. 11. Clinically insignificant laboratory values at screening. 12. Ability to swallow and retain oral medication. 13. Patient having negative urine screen for drugs of abuse. 14. Female patients of childbearing potential, in addition to having a negative serum pregnancy test, must be willing to use a reliable means of contraception (other than hormonal contraceptives) e.g. barrier method (diaphragm, condom, etc.), surgical sterilization (at least 6 months prior to study drug administration) or abstinence for the duration of the study. Patients must use the reliable method of contraception from screening, during study and up to and for at least two weeks after treatment discontinuation. 15. Male patient must agree to use a reliable method of contraception from screening, during study and for at least two weeks after treatment discontinuation. 16. Patients must have a willingness and ability to comply with the protocol requirements.
Exclusion criteria
Exclusion criteria: 1. Pregnant and lactating females. 2. Treatment naÃ?¯ve patients who are not stable on 800 mg VOTRIENTÃ?® for a period of minimum fifteen days during the stabilization period. 3. Patients receiving any medications or substances that are strong inhibitors or inducers of the CYP450 enzyme. 4. Patients receiving any drugs known to prolong the QT interval within 4 weeks prior to study or during the study. 5. Patients with any haematological, renal, neurological or liver injury > Grade 3 toxicity due to prior systemic therapy regimens. 6. Patients with uncontrolled hypertension while receiving appropriate medication (systolic blood pressure greater than or equal to 150 mmHg and diastolic blood pressure greater than or equal to 90 mmHg). 7. Patients with brain metastases as confirmed by a computed tomography (CT) or magnetic resonance imaging (MRI). 8. Clinically significant gastrointestinal abnormalities which might interfere with oral dosing as per Investigatorââ?¬•s discretion: Active peptic ulcer disease; known intraluminal metastatic lesion/s with suspected bleeding; inflammatory bowel disease; ulcerative colitis, or other gastrointestinal conditions with increased risk of perforation; history of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within one month prior to beginning study treatment; malabsorption syndrome; major resection of the stomach or small bowel. 9. Any significant medical comorbidities or intercurrent illnesses or infection that could limit compliance with study medications or increase the risk of treatment-related toxicities as determined by the Investigator. 10. Prolongation of corrected QT interval > 480 msecs using Bazettââ?¬•s formula: 11. History of Cardiac disease. 12. Hypokalemia, hypomagnesaemia, long QT syndrome. 13. Presence of proteinuria. 14. History of any one of more of the following cardiovascular conditions within the past 6 months: 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 defined by the New York Heart Association (NYHA); serious cardiac arrhythmias; history of cerebrovascular accident, stroke (including transient ischemic attack), pulmonary embolism or untreated deep venous thrombosis within the past 6 months. 15. Hemoptysis within 6 weeks of first dose of investigational product. 16. Evidence of active bleeding or bleeding diathesis. 17. Anticoagulant treatment with curative intent. 18. Positive test for hepatitis B surface antigen, hepatitis C antibody, or human immunodeficiency virus (HIV) 1 and 2 serological test at screening. 19. History of alcohol dependence, alcohol abuse or drug abuse within the past 6 months. 20. Concomitant participation in another clinical study estimating an experimental agent within the past one month. 21. Known immediate or delayed hypersensitivity reaction to pazopanib. 22. Psychological, familial, sociological, or geographical conditions that do not permit compliance with the protocol. 23. Clinically assessed as having inadequate venous access for PK sampling. 24. Patients with suspected/confirmed novel coronavirus infection (COVID-19) or history of travel/contact with any COVID
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| The secondary objective of this study is to evaluate the safety and tolerability of the patients exposed to the pazopanib tablets 200 mg in patients of advanced RCC.Timepoint: At the end of the study when all 44 patients have completed the study | — |
Primary
| Measure | Time frame |
|---|---|
| The primary objective of this study is to characterize the pharmacokinetic (PK) profile of the test formulation (pazopanib tablets 200 mg of Sun Pharmaceutical Industries Ltd.) relative to that of reference formulation (VOTRIENTÃ?® tablets 200 mg) in patients of advanced RCC who are tolerating a stable dose of Pazopanib tablets 800 mg once daily and to assess the bioequivalence after multiple dose administration under fasting condition.Timepoint: At the end of the study when all 44 patients have completed the study | — |
Countries
India
Contacts
Public ContactDr Sudershan Kumar
Sun Pharmaceutical Industries Ltd
Outcome results
None listed