Health Condition 1: C659- Malignant neoplasm of unspecifiedrenal pelvis
Conditions
Interventions
Intervention1: Pazopanib tablets 200 mg at a dose of 800 mg (4x200 mg tablets) of Eugia Pharma Specialities Limited, India: 800 mg (4 x 200 mg tablets) once daily under fasting conditions
Control Inte
Sponsors
Eugia Pharma Specialities Limited India
Eligibility
Inclusion criteria
Inclusion criteria: -Male and/or female patient of age in between 18 years to 65 years. -Confirmed diagnosis of advanced renal cell carcinoma receiving a stable dose of Pazopanib tablets 800 mg/day for minimum of 14 days prior to randomization. -Patient with estimated life expectancy >= 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 PI at screening only. -Patient with no persistent toxicities from prior medications. -Patient with adequate organ and bone marrow function based upon the following criteria at the time of screening Hemoglobin >= 9.0 g/dL, Absolute neutrophil count >= 1500/uL, Platelet count >= 100,000/uL, Creatinine < 2 x ULN, ALT and AST < 2.5 Ã? upper limit of normal, Total bilirubin within <= 1.5 Ã? upper limit of normal, Clinically insignificant serum glucose levels, S. BUN and Urine protein levels, Patient with no significant medical comorbidities or intercurrent illnesses that could limit compliance with study medications or increase the risk of treatment-related toxicities, 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, Women of childbearing potential are using adequate contraceptive methods. These contraceptive methods should be used during treatment and for at least two weeks after treatment discontinuation, Males with female partners of reproductive potential to use condoms during treatment with pazopanib and for at least two weeks after the last dose, Patient willing to and able to comply with the protocol
Exclusion criteria
Exclusion criteria: -Patient who are hypersensitive to Pazopanib and its excipients. -Patient with ECOG status >2. -Patient with uncontrolled hypertension. -Patient with history of cardiac. -Patients with history or clinical findings of Reversible Posterior Leukoncephalopathy syndrome. -Patient with hepatic or renal dysfunction as per Investigatorâ??s discretion and/or with history of hypokalemia, hypomagnesemia. -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 brain/ 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 500 msec for males or > 470 msec for females, Torsades de Pointes -Patient with positive test for HIV and/or Hepatitis B and/ or HCV or having history of the same. -Patient receiving any medications that are strong inhibitors or inducers of the CYP450 enzyme and/ or any drugs known to prolong QT interval within 4 weeks prior to study or during the study. -Patient with positive test for urine drugs of abuse and/or alcohol breath test. -Patient is smoker or alcoholic. - Patient with history of difficulty with donating blood or difficulty in accessibility of veins. -Patient who consumes grapefruit/ sweet limejuice 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 dosing in the study and/ or history of difficulty with donating blood or difficulty in accessibility of veins. -Patient participated in another clinical trial in the last 90 days. -Pregnant and lactating females. -Active GI disorders with increased risk of perforation; history of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 4 weeks prior to beginning study treatment. -Malabsorption syndrome or disease that could significantly affect gastrointestinal function, or major resection of the stomach or small bowel that could affect the absorption of pazopanib.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To determine steady state bioequivalence of Pazopanib tablets 200 mg of Eugia Pharma Specialities Limited, India with VOTRIENT® (pazopanib) tablets 200 mg of Novartis Pharmaceuticals Corporation, USA in adult patients with advanced renal cell carcinoma already receiving Pazopanib HCl tablets in standard therapy, and who are tolerating a stable dosing regimen of 800 mg/day (4 Ã? 200 mg) under fasting conditions.Timepoint: Venous blood samples (3 mL) will be withdrawn within 5 minutes prior to dosing on Day 14, 15 and 16 (P-I) and 30, 31 and 32 (P-II) to confirm steady state condition. Venous blood samples (3 mL) will be withdrawn on Day 16 and 32 at 0.25, 0.50, 0.75, 1.00, 1.50, 2.00, 2.50, 3.00, 3.50, 4.00, 5.00, 6.00, 8.00, 10.00, 12.00, 16.00 and 24.00 hours post drug administration. | — |
Secondary
| Measure | Time frame |
|---|---|
| To assess safety and tolerability of Pazopanib tablets 800 mg/day (4 Ã? 200 mg).Timepoint: Blood collection for evaluation of safety at Screening and End of Study. A complete blood picture evaluation on Day 0, Day 13 of P-I and Day 29 of P-II. Evaluation of serum electrolytes (Ca, Mg, K, Na, Cl), LFT (AST, ALT, ALP) and Bilirubin at Day 0 and Day 13 of period-I. Serum electrolytes will also be measured at Day 29 of period-II. | — |
Countries
India
Contacts
Public ContactDinesh Kumar Garg
Raptim Research Pvt. Ltd.
Outcome results
None listed