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CTRI Number  CTRI/2014/10/005130 [Registered on: 22/10/2014] Trial Registered Retrospectively
Last Modified On: 14/09/2017
Post Graduate Thesis  No 
Type of Trial  BA/BE 
Type of Study    
Study Design  Randomized, Crossover Trial 
Public Title of Study   To study the effect of two drugs – Capecitabine 500 mg (Test product by Reliance Life Sciences Pvt. Ltd., India) and Xeloda® (Capecitabine 500 mg by Roche Pharma AG, Germany)  
Scientific Title of Study   A multicentre, randomized, open-label, single dose, two-treatment, three-period, three-sequence, partial replicate, crossover, pivotal bioequivalence study of Test capecitabine 500 mg tablet manufactured by Reliance Life Sciences Pvt. Ltd., India with Xeloda® (capecitabine 500 mg) manufactured by Roche Pharma AG, Germany in adult, human, cancer patients under fed condition. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
RLS/0314/021, version 01 dated 03-04-2014  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Pravin Ghadge  
Designation  Medical Monitor 
Affiliation  Reliance Life Sciences Pvt.Ltd 
Address  Dhirubhai Ambani Life Sciences Centre R-282 TTC Area of MIDC Rabale Mumbai Maharashtra 400701, India.

Thane
MAHARASHTRA
400701
India 
Phone  02267678431  
Fax  02240678299  
Email  Pravin.ghadge@relbio.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Pravin Ghadge  
Designation  Medical Monitor 
Affiliation  Reliance Life Sciences Pvt.Ltd 
Address  Dhirubhai Ambani Life Sciences Centre R-282 TTC Area of MIDC Rabale Mumbai Maharashtra 400701, India.

Thane
MAHARASHTRA
400701
India 
Phone  02267678431  
Fax  02240678299  
Email  Pravin.ghadge@relbio.com  
 
Details of Contact Person
Public Query  
Name  Dr Sanjeev Hegde 
Designation  Head- Clinical Development 
Affiliation  Reliance Life Sciences Pvt.Ltd 
Address  Dhirubhai Ambani Life Sciences Centre R-282 TTC Area of MIDC Rabale Mumbai Maharashtra 400701, India

Thane
MAHARASHTRA
400701
India 
Phone  02267678208  
Fax  02267678299  
Email  sanjeev.hegde@relbio.com  
 
Source of Monetary or Material Support  
Reliance Life Sciences Pvt. Ltd. Dhirubhai Ambani Life Sciences Centre, Plot R-282 TTC Area of MIDC, Rabale, Navi Mumbai 400 701 India.  
 
Primary Sponsor  
Name  Reliance Life Sciences Pvt Ltd 
Address  Reliance Life Sciences Pvt. Ltd. Dhirubhai Ambani Life Sciences Centre, Plot R-282 TTC Area of MIDC, Rabale, Navi Mumbai 400 701.  
Type of Sponsor  Pharmaceutical industry-Global 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 13  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Vikram Gota Assisstant Professor  Advanced Centre For Treatment Research &   Advanced Centre For Treatment Research & Education In Cancer, Dr. Gotas Lab, Kharghar, Navi Mumbai-410210
Raigarh
MAHARASHTRA 		 9869631526

vgota@actrec.gov.in 
Dr Jadhav Associate Professor  B. J. Govt. Medical College &   Dr. KiranKumar Jadhav, B. J. Govt. Medical College & Sasoon General Hospitals, Surgery Department, 1st Floor, Block No. 10 Pune Station, Pune-411001, Maharashtra, India
Pune
MAHARASHTRA 		 9823949126

drkpjadhav@gmail.com 
Dr Attili Medical Oncologist  BIBI Cancer Hospital, & Cancer Centre  BIBI Cancer Hospital, & Cancer Centre,Department of Oncology 3rd Floor, Clinical Research Division, 16-3-991/1/C Govt. printing press road, Malakpet, Hyderabad-500024. India
Hyderabad
ANDHRA PRADESH 		 040-24410792

sureshattili@yahoo.com 
Dr Praveen Gantawar Medical Oncologist  Columbia cancer Hospital & Research Centre  Columbia cancer Hospital & Research Centre, 3rd Floor, Hyatt medicare, Dr. Khare marg, Dhantoli, Nagpur-440012
Nagpur
MAHARASHTRA 		 9823038498

jueely1194@yahoo.co.in 
Dr Vijay Palwe Medical Oncologist  Curie Manavata Cancer Institute  Curie Manavata Cancer Institute; Clinical research dept. Opp Mahamarg Bus stand, Mumbai-Naka,Nashik-422004
Nashik
MAHARASHTRA 		 91-9823061929

drraj@manavatacancercentre.com 
Dr Madhukar Thakre Surgical Oncologist  Dr. Baraskar Hospital and Cancer Care Center  Room 05 3rd Floor 278 Central Bazaar Road Ramdaspeth Nagpur 440010
Nagpur
MAHARASHTRA 		 7122420050

jpcancercare2005@yahoo.co.in 
Dr Bhavesh Parekh  HCG Cancer Centre  Department of Medical Oncology Ground Floor, OPD Area HCG Cancer Centre, Sola Science City Road Nr Sola Bridge, S.G.Highway Ahmedabad- 380060
Ahmadabad
GUJARAT 		 9825034353

bhaveshdm1@hotmail.com 
Dr Gunaseelan  Jawaharlal Nehru Institute of   Department of Medical Oncology Jawaharlal Nehru Institute of Post Graduate Medical Education & Research Dhanvantari Nagar Puducherry - 605006
Pondicherry
PONDICHERRY 		 9362966444

gunapgi@gmail.com 
Dr Voona  Mahatma Gandhi Cancer Hospital  Mahatma Gandhi Cancer Hospital & Research Institute A unit of Vizag Hospital and Cancer Research Centre 1/7 MVP Colony, Vishakapatnam- 530046
Visakhapatnam
ANDHRA PRADESH 		 9848191287

muralivoona@yahoo.com 
Dr Kirushna Kumar  Meenakshi Mission Hospital  Department of Oncology Meenakshi Mission Hospital and Research Centre, Lake Area, Melur Road Madurai- 625107
Madurai
TAMIL NADU 		 9787713004

drkskk@yahoo.com 
Dr Bala Shankar Assisstant Professor  MNJ Institute of Oncology &   MNJ Institute of Oncology & Regional Cancer Centre, Deparment of Radiation Oncology, 2nd Floor, Clinical Research Division, Red Hills, Hyderabad-500004, A.P
Hyderabad
ANDHRA PRADESH 		 9963696117

sankarrmc2004@yahoo.co.in 
Dr Shanmuga Kumar Professor of Radiation Oncology  Rajiv Gandhi Government General Hospital  Rajiv Gandhi Government General Hospital & Madras Medical College,Department of Radiation Oncology; No.1 Opposite to Central Railway Station,
Chennai
TAMIL NADU 		 9441442322

drssk57@yahoo.co.in 
Dr Arun Harwani Oncosurgeon  Sujan Surgical Cancer Hospital & Amravati Cancer Foundation,  Sujan Surgical Cancer Hospital & Amravati Cancer Foundation, 52/B Shankar Nagar Main Road, Amravati-444606
Amravati
MAHARASHTRA 		 9823097573

dr_rsaroa2@rediffmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 9  
Name of Committee  Approval Status 
Amravati Ethics Committee  Approved 
BIBI Institutional Ethics Committee  Approved 
Institutional Ethics Committee Madras Medcial & Rajiv Gandhi Government Hospital  Approved 
Institutional Ethics Committee of B.J. Govt. Medical College & Sassoon general Hospitals  Approved 
Jasleen Hospitals Ethics Committee, Nagpur  Approved 
Jasleen Hospitals Ethics Committee, Nagpur  Approved 
Manavta Clinical Research Institute  Approved 
MNJ Institute of Oncology & Regional Cancer Centre Ethics Committee  Approved 
Tata Memorial Centre, Advanced Cancer Treatment, research & Education in Cancer , Institutional ethics Committee  Submittted/Under Review 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Patients of locally advanced or metastatic breast cancer or metastatic colorectal cancer or post-surgery stage III (Dukes’ stage C) colon cancer ,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Capecitabine 500mg (Relicitabine)  Patients will be administered drug (Test or the Comparator depending on the Randomization sequence) on Day 1, Day 2, Day 3 of the study (in single treatment Cycle). The route of administration will be per oral 
Comparator Agent  Xeloda® (Capecitabine 500mg Tablets)   Patients will be administered drug (Test or the Comparator depending on the Randomization sequence) on Day 1, Day 2, Day 3 of the study (in single treatment Cycle). The route of administration will be per oral 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1. Males or females 18 to 65 years of age.
2. Patients with Body Mass Index (BMI) between 17 kg/m2 and 30 kg/m2.
3. Patients in whom capecitabine is indicated as adjuvant treatment following surgery of stage III (Dukes’ stage C) colon cancer
Or
Patients with metastatic colorectal cancer
Or
Patients with locally-advanced or metastatic breast cancer
4. Cancer patients who are already receiving stable twice-daily dosing regimen of capecitabine as monotherapy as prescribed by treating physician.
5. Patients with Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.
6. Patients with life expectancy of at least 3 months.
7. Patients should be non-smokers.
8. Patients willing to voluntarily provide written informed consent or consent from a Legally Acceptable Representative (LAR), if the patient is not in a condition to give consent.
 
 
ExclusionCriteria 
Details  Exclusion Criteria
1. Patients with inadequate venous access to allow the collection of all samples via venous cannula in the study.
2. Pregnant (female patients with a positive serum pregnancy test at screening or positive urine pregnancy test before period I of hospitalization) or lactating females
3. Patients with the following abnormal laboratory parameters:
4. Patients with a known hypersensitivity to fluoropyrimidine therapy or known sensitivity to 5- fluorouracil, receiving concomitant therapy of warfarin,or known Dihydropyrimidine dehydrogenase (DPD) deficiency.
5. Patients with known brain metastasis
6. History or evidence of uncontrolled coagulopathy.
7. History of hereditary galactose/ glucose/ lactase disorders.
8. History or evidence of cardiac disease
9. Patients with a history of alcoholism, or drug abuse
10. Patients diagnosed to be HIV 1 and 2 or Hepatitis B (HBsAg) or Hepatitis C (HCV) virus positive.
11. Patients having an abnormal serum calcium level
12. Patients who have participated in any other clinical investigation using experimental drugs
13. Patients with hepatic impairment and severe renal impairment.
14. Any other condition which the investigator feels would pose a significant hazard to the patient if capecitabine is administered.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Centralized 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To establish the bioequivalence of Test vs Reference in relation to the rate and extent of absorption on the basis of the following pharmacokinetic parameters of Capecitabine during the course of study. PK sampling from Day1 to Day3. 12 PK samples in each period from 0 hours to 8 hours:
• Cmax
• AUC0-t
 		 To establish the bioequivalence of Test vs Reference in relation to the rate and extent of absorption on the basis of the following pharmacokinetic parameters of Capecitabine during the course of study. PK sampling from Day1 to Day3. 12 PK samples in each period from 0 hours to 8 hours:
• Cmax
• AUC0-t
 
 
Secondary Outcome  
Outcome  TimePoints 
1. To monitor adverse events, including clinically significant laboratory parameters.
2. To determine other pharmacokinetic parameters of Test and Reference products for Capecitabine during the course of study
• Tmax
• AUC0-∞
• Kel
• t1/2
 		 1. To monitor adverse events, including clinically significant laboratory parameters.
2. To determine other pharmacokinetic parameters of Test and Reference products for Capecitabine during the course of study
• Tmax
• AUC0-∞
• Kel
• t1/2
 
 
Target Sample Size   Total Sample Size="66"
Sample Size from India="66" 
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)   24/08/2014 
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="0"
Days="5" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Closed to Recruitment of Participants 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary   The purpose of the study is to demonstrate the bioequivalence between Test capecitabine 500 mg tablet manufactured by Reliance Life Sciences Pvt. Ltd., India with Xeloda® (capecitabine 500 mg) manufactured by Roche Pharma AG, GermanyThe patients will either be assigned to Test or Reference product. The bioequivalence will be assessed under fed conditions. In each period, all patients will observe overnight fasting of at least 10 hours prior to intake of a high calorie high fat breakfast. As per the randomization schedule, the patients will be administered a single dose of either Test capecitabine or Reference Xeloda® within 30 minutes after intake of a high calorie high fat breakfast. Patients will be instructed not to chew or crush the drug, and will be asked to take it with the specified quantity of water. Compliance will be assessed by conducting a thorough examination of the oral cavity using a flashlight and spatula by trained study personnel after each dosing. 
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