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1 Clinical Trial Details (PDF Generation Date :- Fri, 08 Mar :39:17 GMT) CTRI Number Last Modified On 21/11/2018 Post Graduate Thesis Type of Trial Type of Study Study Design Public Title of Study Scientific Title of Study CTRI/2016/03/ [Registered on: 18/03/2016] - Trial Registered Prospectively BA/BE Randomized, Crossover Trial A Study Comparing Capecitabine Capsule 500 mg (Intas Pharmaceuticals Ltd., ) To The Reference Listed Drug Xeloda (Capecitabine 500 mg; Roche Pharmaceuticals) In Patients Of Breast Cancer Or Colorectal Cancer Under Fed Condition A Multicentre, Randomized, Open Label, Two-Period, Two-Treatment, Two-Way Crossover, Comparative Bioavailability Study At Steady State Comparing Capecitabine Extended Release Capsule 500 mg (Intas Pharmaceuticals Ltd., ) To The Reference Listed Drug Xeloda (Capecitabine 500 mg; Roche Pharmaceuticals) In Patients Of Breast Cancer Or Colorectal Cancer Under Fed Condition Secondary IDs if Any Secondary ID Identifier Details of Principal Investigator or overall Trial Coordinator (multi-center study) Details Contact Person (Scientific Query) Details Contact Person (Public Query) , Version: 1.0, Date: 08/09/2015 Protocol Number Details of Principal Investigator Mr Srinivasa Rao Project Manager Phone Lambda Therapeutic Research Ltd. Plot. 38, Near Silver Oak Club S. G. Highway, Gota srinivasarao@lambda-cro.com Details Contact Person (Scientific Query) Dr Manjunath K GM Phone Lambda Therapeutic Research Ltd Plot. 38, Near Silver Oak Club S. G. Highway, Gota manjunathk@lambda-cro.com Details Contact Person (Public Query) Dr Ankit Ranpura Manager Lambda Therapeutic Research Ltd Plot. 38, Near Silver Oak Club S. G. Highway, Gota page 1 / 5

2 Source of Monetary or Material Support Primary Sponsor Details of Secondary Sponsor Countries of Recruitment Sites of Study Phone Source of Monetary or Material Support > Intas Pharmaceuticals Ltd. 2nd Floor, Chinubhai Center, Ashram Road, Ahmedabad , Gujarat,, Tel..: , Fax: Primary Sponsor Details Intas Pharmaceuticals Ltd 2nd Floor, Chinubhai Center, Ashram Road, Ahmedabad , Gujarat,, Tel..: , Fax: Type of Sponsor List of Countries of Principal Investigator Pharmaceutical industry-n of Site Site Phone/Fax/ Dr Hari Goyal Artimis Hospitals Artimis Hospitals, Dept of oncology, Room Number , Sector: 51, Pin Gurgaon HARYA Dr Bala Murgan Guru Hospital Room 5, Dept. of Clinical Research, Plot. - 4/120-F, Pandikovil Ring Road, Mattuthavani, Madurai Madurai TAMIL DU Dr Anil Poddar Dr Nagesh Srinivas Mandoorkar Dr Shamsuddin Jalaluddin Virani Health Point A Multi Speciality Hospital drgoyalhari@hotmail.co m info@guruhospitals.co m Room -12,Dept of oncology, OPD Section, Health Point Multi dranilpoddar@hotmail.c Speciality Hospital, 21, om Prannath pandit street (Opposite lansdown Padmapukur) Kolkata WEST BENGAL Magnum Heart Institute Magnum Heart Institute, Chopda Medicare and Research Centre, 3rd Floor, Dept of oncology Room no. 5, Laxmi Nagar, Patil lane. 1, Near KBH Vidyalay, Canada Corner Nashik MAHARASHTRA Unique Hospital Multispeciality & Research Institute. Clinical Research Department, Unique Hospital Multispeciality & Research Institute, nmadnoorkar@yahoo.c o.in drsjvirani@gmail.com page 2 / 5

3 Details of Ethics Committee Regulatory Clearance Status from DCGI Health Condition / Problems Studied Intervention / Comparator Agent Inclusion Criteria Dr K B Akila VGM Cancer Care A Unit Of VGM hospital Room -4, Opp. Kiran Motor, Near Canal, Civil hospital Char Rasta - Sosyo Circle Lane, Off Ring Road Surat Dept of Surgical oncology, Room no: 5, 4/120 F, PandiKovil Ring road Madurai TAMIL DU kbakila@yahoo.co.in of Committee Approval Status Date of Approval Is Independent Ethics Committee? Artimis Health Science Committee, Dr. Hari Goyal Ethics Committee, Unique Hospital Multispeciality & Research Institute, Dr. Shamsuddin Jalaluddin Virani Health Point Ethics committee, Dr. Anil Poddar committee VGM Hospital, Dr. K B Akila committee, Guru Hospital, Dr. Bala Murgan Magna Care Ethics Committee, Dr. Nagesh Srinivas Mandoorkar Status Date Specified Date Specified Date Specified Date Specified Approved 29/02/2016 Date Specified Date Approved/Obtained 11/12/2015 Health Type Patients Condition Malignant neoplasm of colon, unspecified Type Details Intervention Comparator Agent Age From Age To Capecitabine Extended Release Capsule 500 mg (Intas Pharma) Xeloda (Capecitabine) film coated tablets 500 mg (Roche Pharmaceuticals) Year(s) Year(s) Inclusion Criteria Dose: 1250 mg/m2, Frequency: twice daily, Mode of Administration: orally, Duration of treatment: One week Dose: 1250 mg/m2, Frequency: twice daily, Mode of Administration: orally, Duration of treatment: One week page 3 / 5

4 Gender Details Both 1. Male or Female?18 to? 65 years of age and having a Body Mass Index (BMI) at least 17 calculated as weight in kg / height in m2 2. Patients must have/have had histopathologically /cytologically confirmed breast cancer or colorectal cancer. 3.Patients with a. Metastatic colorectal carcinoma when treatment with fluoro pyrimidine therapy alone is preferred. b. Metastatic breast cancer resistant to both paclitaxel and an anthracycline-containing chemotherapy regimen 4. Eastern Cooperative Oncology Group (ECOG) performance status? Patient with adequate bone marrow, renal and hepatic function. 6. Adequate Cardiac function (left ventricular ejection fraction[lvef]?50%) 7. Patient should have recovered from any toxic effects of previous chemotherapy as judged by the Investigator 8. Able to comply with study requirement in opinion of Principal Investigator. 9. Able to give written informed consent for participation in the trial. Exclusion Criteria Details Exclusion Criteria 1.Prior unanticipated severe reaction to fluoropyrimidine therapy, or known sensitivity to 5-fluorouracil, or known DPD (Dihydropyrimidine Dehydrogenase) deficiency. 2. Pregnant or breast-feeding female 3. History of drug/alcohol addiction 4. Known brain metastasis 5. Pre-existing motor or sensory neurotoxicity of a severity? grade 2 by NCI CTCAE criteria. 6. A positive hepatitis screen including hepatitis B surface antigen and HCV antibodies 7. Known case of HIV infection. 8. Any other condition that, in the investigator s judgment, might increase the risk to the patient or decrease the chance of obtaining satisfactory data needed to achieve the objectives of the study. Method of Generating Random Sequence Method of Concealment Blinding/Masking Computer generated randomization t Applicable Open Label Primary Outcome Outcome Timepoints AUC Day 07 and Day 14 Secondary Outcome Outcome Timepoints Target Sample Size To monitor the safety of the patients who are exposed to the investigational medicinal product. Total Sample Size=24 Sample Size from =24 Day 1 to Day 14 page 4 / 5

5 Powered by TCPDF ( Phase of Trial Date of First Enrollment () Date of First Enrollment (Global) Estimated Duration of Trial Recruitment Status of Trial (Global) Recruitment Status of Trial () Publication Details Brief Summary N/A 23/03/2016 Date Specified Years=0 Months=8 Days=0 t Applicable t Yet Recruiting The Sponsor has developed extended release formulation of capecitabine. Capecitabine is a cytotoxic drug. It would be unethical to do this study in healthy volunteers. Therefore the comparative bioavailability study is proposed to be carried out on patients with Breast Cancer or Colorectal cancer, who in the opinion of their treating physicians are candidates for Capecitabine therapy In current study, test formulation of capecitabine ER capsule 500 mg will be administered as twice daily for one week and reference formulation of capecitabine - Xeloda (capecitabine) tablets 500 mg will be administered twice daily for one week in a crossover manner in patients with breast cancer or colorectal cancer under fed condition. Through this study, we will prospectively collect the data from adult breast cancer or colorectal cancer patients who will be randomly assigned to receive either capecitabine extended release capsule of Intas Pharmaceuticals Limited, or Xeloda (Capecitabine 500 mg; Roche Pharmaceuticals) for the pharmacokinetic profiling. page 5 / 5