Pharmacokinetic Study of Pazopanib in Advanced Renal Cell Carcinoma patients.
Active, not recruiting
- Conditions
- Malignant neoplasm of unspecifiedkidney, except renal pelvis,
- Registration Number
- CTRI/2020/07/026341
- Lead Sponsor
- Sun Pharmaceutical Industries Ltd India
- Brief Summary
Multicenter, Randomized, Open Label, Steady State, Balanced, Two Treatment, Two Period, Twoâ€Way Crossover, Bioequivalence Study Under Fasting Condition Comparing Pazopanib 200 mg Tablet (Sun Pharmaceutical Industries Ltd.) to the Reference Listed Drug VOTRIENT® (Pazopanib) 200 mg Tablet of Novartis Pharmaceuticals Corporation, in Patients of Advanced Renal Cell Carcinoma who are Tolerating a Stable Dose of Pazopanib Tablets 800 mg Once Daily
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 (VOTRIENT® 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Closed to Recruitment of Participants
- Sex
- All
- Target Recruitment
- 44
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.
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- 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
- 1.Pregnant and lactating females.
- 2.Treatment naïve patients who are not stable on 800 mg VOTRIENT® 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 Investigator’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 Bazett’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.
- 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.
- 21.Known immediate or delayed hypersensitivity reaction to pazopanib.
- 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-19 positive patient.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 (VOTRIENT® 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. At the end of the study when all 44 patients have completed the study
- Secondary Outcome Measures
Name Time Method 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. At the end of the study when all 44 patients have completed the study
Trial Locations
- Locations (15)
Aakash Healthcare Super Specialty Hospital
🇮🇳West, DELHI, India
Apex Hospital
🇮🇳Varanasi, UTTAR PRADESH, India
Banaras Hindu University
🇮🇳Varanasi, UTTAR PRADESH, India
EVAA Super Speciality Hospital
🇮🇳Jaipur, RAJASTHAN, India
GSVM, Kanpur
🇮🇳Nagar, UTTAR PRADESH, India
HCG Manavata Cancer Centre
🇮🇳Nashik, MAHARASHTRA, India
Life Line Daignostic Center Cum Nursing Home
🇮🇳Kolkata, WEST BENGAL, India
Marathwada Regional Cancer Centre & Research Institute
🇮🇳Aurangabad, MAHARASHTRA, India
Masina Hospital
🇮🇳Mumbai, MAHARASHTRA, India
Navsanjeevani Hospital
🇮🇳Nashik, MAHARASHTRA, India
Scroll for more (5 remaining)Aakash Healthcare Super Specialty Hospital🇮🇳West, DELHI, IndiaDr Chandragouda DodagoudarPrincipal investigator9958450124drchandru1976@yahoo.co.in