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CTRI Number  CTRI/2021/04/032507 [Registered on: 01/04/2021] Trial Registered Prospectively
Last Modified On: 16/06/2022
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Crossover Trial 
Public Title of Study   Multiple dose, steady-state relative bioavailability of Pazopanib 200 mg tablets at a dose of 800 mg (4x200 mg tablets) in subjects with advanced renal cell carcinoma under fasting condition.  
Scientific Title of Study   A randomized, open label, multi-center, two-treatment, two-period, two-sequence, two-way cross-over, multiple dose, steady-state relative bioavailability study of Pazopanib 200 mg tablets at a dose of 800 mg (4x200 mg tablets) of Oncogen Pharma (Malaysia) Sdn. Bhd., and Votrient® (Pazopanib) 200mg film-coated tablets at a dose of 800 mg (4x200 mg tablets) manufactured by Glaxo Operations UK Ltd, United Kingdom, in subjects with advanced renal cell carcinoma under fasting condition. 
Trial Acronym  NA 
Secondary IDs if Any  
Secondary ID  Identifier 
CBCC/2020/035, Version No. 1.0 dated 24/Dec/2020   Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Sandeep Singh 
Designation  Vice President – Clinical Operations 
Affiliation  CBCC Global Research LLP 
Address  Second Floor, Skoda House, Opposite L J Campus S G Highway, Sarkhej, Ahmedabad, GUJARAT – 382210, India

Ahmadabad
GUJARAT
382210
India 
Phone  9637555304  
Fax  9726434204  
Email  sandeep.singh@cbccusa.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Sandeep Singh 
Designation  Vice President – Clinical Operations 
Affiliation  CBCC Global Research LLP 
Address  Second Floor, Skoda House, Opposite L J Campus S G Highway, Sarkhej, Ahmedabad, GUJARAT – 382210, India


GUJARAT
382210
India 
Phone  9637555304  
Fax  9726434204  
Email  sandeep.singh@cbccusa.com  
 
Details of Contact Person
Public Query  
Name  Dr Sandeep Singh 
Designation  Vice President – Clinical Operations 
Affiliation  CBCC Global Research LLP 
Address  Second Floor, Skoda House, Opposite L J Campus S G Highway, Sarkhej, Ahmedabad, GUJARAT – 382210, India


GUJARAT
382210
India 
Phone  9637555304  
Fax  9726434204  
Email  sandeep.singh@cbccusa.com  
 
Source of Monetary or Material Support  
Oncogen Pharma (Malaysia) Sdn. Bhd No. 3, Jalan Jururancang U1/21, Hicom Glenmarie Industrial Park, 40150 Shah Alam, Selangor, Malaysia  
 
Primary Sponsor  
Name  Oncogen Pharma Malaysia Sdn Bhd 
Address  No. 3, Jalan Jururancang U1/21, Hicom Glenmarie Industrial Park, 40150 Shah Alam, Selangor, Malaysia  
Type of Sponsor  Pharmaceutical industry-Global 
 
Details of Secondary Sponsor  
Name  Address 
NA  NA 
 
Countries of Recruitment     India  
Sites of Study
Modification(s)  
No of Sites = 9  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Lovenish Goyal  Aadhar Health Institue  Tosham Road, Near South Bypass Crossing, Hisar, Haryana - 125005 India
Hisar
HARYANA 		 9896539142

drlovenish@gmail.com 
Dr Amol Shankar Dongre  Alexis Multispeciality Hospital Pvt Ltd.  Survey No.232,House No. 1313,Mankapur Square ,Koradi Road,Nagpur-440030, Maharashtra, India
Nagpur
MAHARASHTRA 		 9823311569

adongre@alexishospital.com 
Dr Ravindra Deshmukh  Jasleen Hospital  1st floor, opposite Big Bazar, panchasheel square, wardha road, Nagpur-440012, Maharashtra, India
Nagpur
MAHARASHTRA 		 823056120

dravi1962@gmail.com 
Dr Prateek Tiwari  Jawaharlal Nehru Cancer Hospital And Research Centre  P.B, No. 32, Cancer Hospital Rd, Idgah Hills, Bhopal-462001, Madhya Pradesh, India
Bhopal
MADHYA PRADESH 		 7999714077

prateekmedconc@gmail.com 
DrMahesh Kalloli  KLES Dr.Prabhakar Kore Hospital and Medical Research centre  Nehru Nagar,Belagavi-590010,Karnataka,India
Belgaum
KARNATAKA 		 9945014996

mahesh.kalloli@gmail.com 
Dr Bahar Kulkarni  MTE’s Sanjeevan Hospital  Plot No. 23, Off Karve Road, Erandwane, Pune – 411004, Maharashtra, India
Pune
MAHARASHTRA 		 9823436677

drbaharkulkarni96@gmail.com 
Dr Mukesh C Arya  Sardar Patel Medical College and AG of Hospital  SP Medical College Road, Bikaner, Rajasthan-334001, India
Bikaner
RAJASTHAN 		 9782300231

mcarya@yahoo.com 
DrNeeraj Jain  Sri Guru Ram Das Institute of Medical Sciences and Research  VPO Vallah Mehta Road, Amritsar-143006, Punjab, India
Amritsar
PUNJAB 		 9810195227

Sk1957@gmail.com 
Dr Rajendra singh Arora  Sujan Surgical Cancer Hospital & Amravati Cancer foundation  52/b Shankar Nagar Main Road Amravati, Maharashtra - 444606, India
Amravati
MAHARASHTRA 		 9823097573

dr_rsarora@rediffmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 9  
Name of Committee  Approval Status 
Aadhar Institutional Ethics committee  Approved 
AMRAVATI ETHICS COMMITTEE  Approved 
Ethics Committee Sanjeevan Hospital  Approved 
ETHICS COMMITTEE, S.P.MEDICAL COLLEGE, BIKANER  Approved 
INSTITUTIONAL ETHICS COMMITTEE OF VIDHARBHA INSTITUTE OF MEDICAL SCIENCES, NAGPUR  Approved 
INSTITUTIONAL ETHICS COMMITTEE SGRDIMSAR  Approved 
INSTITUTIONAL ETHICS COMMITTEE, Alexis Multispeciality Hospital Pvt. Ltd.  Approved 
Institutional ethics committee, Jawaharlal Nehru Cancer Hospital and Research Centre  Approved 
INSTITUTIONAL ETHICS COMMITTEE, KLE University’s  Approved 
 
Regulatory Clearance Status from DCGI  
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 tablets at a dose of 800 mg (4x200 mg tablets) of Oncogen Pharma (Malaysia) Sdn. Bhd.  Dosage: 800 mg (4 x 200 mg tablets) once daily under fasting conditions for 12 days 
Comparator Agent  Votrient® (Pazopanib) 200mg film-coated tablets at a dose of 800 mg (4x200 mg tablets) manufactured by Glaxo Operations UK Ltd, United Kingdom   800 mg (4 x 200 mg tablets) once daily under fasting conditions for 12 days 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  1. Willing and able to provide voluntary informed consent and to follow the protocol requirements.
2. Subjects aged greater than 18 years with BMI at least 17.00 calculated as weight in kg per height in m2.
3. Subjects with confirmed diagnosis of advanced renal cell carcinoma includes,
(a) Newly diagnosed subjects OR
(b) Subjects who are already receiving stable dose of Pazopanib tablets of 800 mg per day for at least 15 days OR
(c) Subjects with failure of first line treatment for advanced renal cell carcinoma and as per investigators discretion are eligible to receive Pazopanib tablets.
4. Subjects able to swallow and retain oral medication
5. Life expectancy of at least 3 months at the time of screening.
6. Acceptable hematology status
a. Hemoglobin greater than or equal to 9.0 g per dL
b. Absolute neutrophil count (ANC) greater than or equal to 1500 cells per mm3
c. Platelet count greater than or equal to 100,000 cells per mm3
7. Acceptable liver function
a. Alanine aminotransferase (ALT) less than or equal to 2 X ULN
b. Aspartate aminotransferase (AST) less than or equal to 2X ULN
c. Bilirubin less than or equal to ULN
8. Subjects with Creatinine clearance greater than or equal to 60 mL per minute
9. Cardiac ejection fraction greater than or equal to 50percent by echocardiogram (ECHO) within 28 days of first dose of Investigational Product.
10. Male subjects (including those who had a vasectomy) with female partners of reproductive potential must agree to use condoms from screening, during study and for at least two weeks after treatment discontinuation.
11. Female subjects of child bearing potential with negative serum pregnancy test at screening and at Day 1.
12. Women of childbearing potential (defined as women physiologically capable of becoming pregnant, unless they are using effective method of contraception during dosing of the investigational product) practicing acceptable methods of contraception from screening, during study and for at least two weeks after treatment discontinuation.
Acceptable methods of contraception are
a. Oral or other (Example- injection, patch or implant) hormonal contraception which has been used continuously for at least one month prior to the first dose of study medication
b. Intrauterine device IUD or intrauterine system IUD or IUS
c. Double barrier method of contraception (Condom and occlusive cap or condom and spermicidal agent)
d. Female sterilization (surgical bilateral oophorectomy) or tubal ligation at least 6 weeks prior to study participation
e. Total abstinence, partial abstinence is not acceptable.
13. No history of addiction to any recreational drug or drug dependence or alcohol addiction.
 
 
ExclusionCriteria 
Details  1. Known hypersensitivity to Pazopanib or the components of investigational product.
2. History or presence of any uncontrolled systemic disease (e.g. cardiovascular disease, hypertension, diabetes mellitus etc.).
3. Subjects with hypokalemia, hypomagnesaemia, long QT syndrome (QTc of > 450 msec in male or QTc of > 470 msec in female) or with relevant pre-existing cardiac disease at the time of screening
4. Subjects found with major vascular disease, arterial thromboembolic event or VTE in previous 6 months from the screening
5. Currently receiving or anticipated to receive any medications or substances that are strong inhibitors or inducers of the CYP3A4, strong inhibitors of P-gp or BCRP; narrow therapeutic index drugs that are metabolized by CYP3A4, CYP2D6 or CYP2C8; simvastatin, H2 receptor antagonist and PPIs.(Appendix B)
6. Subjects who are receiving or are anticipated to receive anti-coagulant therapy during study participation
7. Receiving any drugs known to prolong the QT interval within 4 weeks prior to first IP administration or during the study
8. Known CNS metastasis.
9. History or presence of hemoptysis, cerebral hemorrhage, or clinically significant gastrointestinal hemorrhage in the past 6 months
10. History or presence of TMA or any other dermatological toxicity.
11. History or presence of gastrointestinal perforation or fistula
12. History or presence of Interstitial Lung Disease/Pneumonitis
13. History or presence of Posterior Reversible Encephalopathy Syndrome
14. Subjects who are at risk of TLS (e.g. rapidly growing tumors, a high tumor burden, renal dysfunction, or dehydration)
15. Subjects with ECOG Performance Status of > 2.
16. Major surgical procedure (including periodontal) within 28 days of first dose of Investigational Product.
17. Surgical or other non-healing wounds.
18. Subjects with positive serology for HBV, HCV, or HIV.
19. Subjects who tested positive for Coronavirus infection (COVID-19)
20. Subjects with current clinical or laboratory evidence of active infection.
21. History of other malignancies in the last 5 years
22. Have not recovered to Grade 0 or 1 toxicity from previous anticancer treatments or previous investigational agents. Exceptions are alopecia (any grade is acceptable), hemoglobin ≥ 9.0 g/dL, fatigue (Grade 2 is acceptable), and peripheral neuropathy (stable Grade 2 is acceptable) (as per National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE], V5.0).
23. If subjects found positive in urine alcohol test
24. If subjects found positive in urine screen for drugs of abuse
25. Participation in any clinical study within 90 days before the first dose of Investigational Product.
26. Loss of ≥ 350mL (1 unit) of blood within 90 days before enrollment in the study.
27. Any other medical condition or serious intercurrent illness that, in the opinion of the Investigator, may make it undesirable for the subjects to participate in the study including but not limited to cirrhosis or psychiatric illness/social situations that would limit adherence to study requirements.
28. Lactating women 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Centralized 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To evaluate relative bioavailability of Pazopanib at a dosage of 800 mg (4 x 200 mg) of Oncogen Pharma (Malaysia) Sdn. Bhd. compared to Votrient® (Pazopanib) tablets at a dosage of 800 mg (4 x 200 mg) manufactured by Glaxo Operations UK Ltd, United Kingdom in subjects with advanced renal cell carcinoma under fasting condition.  A total of twenty-eight (28) blood PK blood samples of 3.0 mL each will be collected from each subject during the study duration on day 10, 11, 12, 13 in period 01 and on day 22, 23, 24 & 25 in period 02. 
 
Secondary Outcome  
Outcome  TimePoints 
To monitor the adverse events and to assess the safety and tolerability in subjects.  Safety and tolerability will be asses during screening, on day 01 to 12 in period 01, day 13 to 24 in period 02, on day 25 and day 35 during study 
 
Target Sample Size   Total Sample Size="22"
Sample Size from India="22" 
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)   08/04/2021 
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="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Closed to Recruitment of Participants 
Publication Details   NONE 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   This is a A randomized, open label, multi-center, two-treatment, two-period, two-sequence, two-way cross-over, multiple dose, steady-state relative bioavailability study of Pazopanib 200 mg tablets at a dose of 800 mg (4*200 mg tablets) of Oncogen Pharma (Malaysia) Sdn. Bhd. and Votrient® (Pazopanib) 200mg film coated tablets at a dose of 800 mg (4*200 mg tablets) manufactured by Glaxo Operations UK Ltd, United Kingdom, in subjects with advanced renal cell carcinoma under fasting condition. 
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