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CTRI Number  CTRI/2020/07/026341 [Registered on: 02/07/2020] Trial Registered Prospectively
Last Modified On: 10/01/2022
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Other (Specify) [BE]  
Study Design  Randomized, Crossover Trial 
Public Title of Study   Pharmacokinetic Study of Pazopanib in Advanced Renal Cell Carcinoma patients. 
Scientific Title of Study   A Multicenter, Randomized, Open Label, Steady State, Balanced, Two Treatment, Two Period, Two 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 
Trial Acronym   
Secondary IDs if Any
Modification(s)  
Secondary ID  Identifier 
EA-CT-19-001 Version 1.0 Amendment 2.0 dated 17 Jun 2020  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Bhushan Nemade 
Designation  Radiation Oncologist /Medical Oncologist 
Affiliation  Navsanjeevani Hospital 
Address  Ground Floor, Clinical Research Department, Plot No.8, Motkari Nagar, BehindTupsakhare Lawns, Tidke Colony, Mumbai Naka.

Nashik
MAHARASHTRA
422002
India 
Phone  09766126162  
Fax    
Email  drbtnemade@yahoo.co.in  
 
Details of Contact Person
Scientific Query
Modification(s)  
Name  Dr Kirti Patel 
Designation  Senior Research Manager  
Affiliation  Sun Pharmaceutical Industries Ltd 
Address  Clinical Pharmacology Unit, 2nd Floor HAH-Centenary Hospital, Hamdard Nagar

South
DELHI
110062
India 
Phone  09898555723  
Fax    
Email  Kirti.Patel@sunpharma.com  
 
Details of Contact Person
Public Query  
Name  Dr Sudershan Kumar  
Designation  Senior Manager 
Affiliation  Sun Pharmaceutical Industries Ltd 
Address  Clinical Pharmacology and Pharmacokinetics Sun Pharmaceutical Industries Limited Plot No GP5 Sector 18 Udyog Vihar Industrial Area HSIDC Old Delhi Gurugram Road.

Gurgaon
HARYANA
122 015
India 
Phone  09910445548  
Fax    
Email  sudershan.kumar@sunpharma.com  
 
Source of Monetary or Material Support  
Sun Pharmaceutical Industries Limited Plot No. GP-5, Sector 18 Udyog Vihar Industrial Area,HSIDC, Old Delhi – Gurugram Road Gurugram 122 015, Haryana India 
 
Primary Sponsor  
Name  Sun Pharmaceutical Industries Ltd India 
Address  Sun Pharmaceutical Industries Limited Plot No GP5 Sector 18 Udyog Vihar Industrial Area HSIDC Old Delhi Gurugram Road Gurugram 122015 Haryana India  
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study
Modification(s)  
No of Sites = 15  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Chandragouda Dodagoudar  Aakash Healthcare Super Specialty Hospital   Hospital Plot, Road No 201 Sector 3 Dwarka New Delhi 110075 India
South West
DELHI 		 9958450124

drchandru1976@yahoo.co.in 
Dr Neha Gupta  Apex Hospital  N-7/2A-5D, Bhikaripur, DLW Hydel Road, 221004 India
Varanasi
UTTAR PRADESH 		 8004354185

drneha_500@yahoo.com 
Dr Manoj Pandey  Banaras Hindu University  Professor of Surgical Oncology Institute of Medical Sciences Banaras Hindu University Varanasi 221 005, UP, India
Varanasi
UTTAR PRADESH 		 9336363640

manojpandey66@gmail.com 
Dr Lokesh Sharma  EVAA Super Speciality Hospital  B-28, 29 Govind Marg, Near MD circle, Jaipur, Rajasthan 302004, India
Jaipur
RAJASTHAN 		 9414066853

research.essh@gmail.com 
Dr Vinay Kumar  GSVM, Kanpur  Medical college, Swaroop Nagar 208002
Kanpur Nagar
UTTAR PRADESH 		 09660640989

vinaysinghkgmc99@gmail.com 
DrVijay Palwe  HCG Manavata Cancer Centre  First Floor, Clinical Research Department, Behind Shivang Auto, Mumbai Naka, Nashik-422001, Maharashtra, India.
Nashik
MAHARASHTRA 		 09730073373

drpalwe@mcrinasik.com 
Dr Koushik Chatterjee  Life Line Daignostic Center Cum Nursing Home  4A Wood Street, Kolkata: 700016, India
Kolkata
WEST BENGAL 		 9874357580

drkoushik.chatterjee@gmail.com 
Dr Balaji Keshvrao Shewalkar  Marathwada Regional Cancer Centre & Research Institute  Jama Masjid Aam khas maidan road 431001
Aurangabad
MAHARASHTRA 		 09850632639

bkrish1970@gmail.com 
Dr Preetam Kumar Jain  Masina Hospital  Masina Hospital, Sant savata Mali Marg, Near Gloria church: 400027
Mumbai
MAHARASHTRA 		 99799686262

preetamjain.cancercare@gmail.com 
Dr Bhushan Nemade  Navsanjeevani Hospital  Ground Floor, Clinical Research Department, Plot No.8, Motkari Nagar, Behind Tupsakhare Lawns, Tidke Colony, Mumbai Naka, 422002; India.
Nashik
MAHARASHTRA 		 09766126162

drbtnemade@yahoo.co.in 
Dr Anil Kumar  Oncoville Cancer Hospital And Research Centre  o. 4, 80ft. road, 7th block, Nagarabhavi 2nd stage, Bangalore- 560072
Bangalore
KARNATAKA 		 9739808502

dranil.onco@gmail.com 
Dr Rajeev Sood  RML Hospital  Room no. 31, Urology Dept. OPD building, New Delhi – 110001, India
New Delhi
DELHI 		 9810005182

drsoodr@gmail.com 
Dr Ghanashyam Biswas  Sparsh Hospital & Critical care (P) Ltd  A/407,saheed Nagar, Bhubaneshwar,Odisha-751007, India
Khordha
ORISSA 		 9937500878

drgbiswas@gmail.com 
Dr R Raghu Raman  Srikara Hospitals  Plot No. 50, LB Nagar Hyderabad, Telangana India – 500074
Hyderabad
TELANGANA 		 9989717434

raghuraman3008@gmail.com 
Dr Tanveer Maksud  Unique Hospital- Multispeciality & Research Institute  Opp. Kiran Motor, Nr. Canal, Civil Hospital Char Rasta- Sosyo Circle Lane, Off Ring Road, Surat- 395002, Gujarat, India.
Surat
GUJARAT 		 9909918887

tanveermaksud@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 15  
Name of Committee  Approval Status 
Aakash Healthcare Institutional Ethics Committee   Approved 
Cytomol Independent Ethics Committee  Approved 
Dhanvantri Ethical Committee for Human Research  Approved 
Ethics Committee GSVM Medical College   Approved 
Ethics Committee, PGIMER, Dr. RML Hospital  Approved 
Ethics committee, Unique Hospital  Approved 
IEC Lifeline Diagnostic Center cum Nursing Home  Approved 
INDEPENDENT EC NAMASTE INTEGRATED SERVICES   Approved 
Institutional Ethics Committee I.M.S,B.H.U  Approved 
Institutional Ethics Committee of OCH and RC Oncoville Cancer Hospital And Research Centre  Approved 
Institutional ethics committee, government medical college & hospital, Aurangabad  Approved 
Institutional Ethics committee, Masina Hospital sant savta Marg, Byllulla (East) Mumbai  Approved 
Institutional Ethics committee, Sparsh Hospital, Orrisa  Approved 
Manavata Clinical Research Institute Ethics Committee  Approved 
Navsanjeevani Hospital Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI
Modification(s)  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C649||Malignant neoplasm of unspecifiedkidney, except renal pelvis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  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 800 mg tablet (4×200 mg) or VOTRIENT® (pazopanib) 800 mg tablet (4×200 mg) once daily for 14 days in each period. On Day 15, patients will cross over to the other formulation as per randomization schedule for the next 14 days. 
Comparator Agent  VOTRIENT® tablets, 200 mg of Novartis Pharmaceuticals Corporation’s   Patients will be randomly assigned in a 1:1 ratio to receive either Sun Pharmaceutical Industries Ltd.’s pazopanib 800 mg tablet (4×200 mg) or VOTRIENT® (pazopanib) 800 mg tablet (4×200 mg) once daily for 14 days in each period. On Day 15, patients will cross over to the other formulation as per randomization schedule for the next 14 days. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  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.
 
 
ExclusionCriteria 
Details 
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.
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-19 positive patient.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Centralized 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
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  
Outcome  TimePoints 
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 
 
Target Sample Size   Total Sample Size="44"
Sample Size from India="44" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)
Modification(s)  		 11/09/2020 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="10"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Closed to Recruitment of Participants 
Publication Details   Not yet 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary
Modification(s)  

Multicenter, Randomized, Open Label, Steady State, Balanced, Two Treatment, Two Period, Two‐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.

 
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