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1 Clinical Trial Details (PDF Generation Date :- Sun, 24 Feb :31:20 GMT) CTRI Number CTRI/2010/091/ [Registered on: 07/09/2010] - Last Modified On 29/11/2016 Post Graduate Thesis Type of Trial Type of Study Study Design Public Title of Study Scientific Title of Study No Interventional Drug Randomized, Parallel Group, Active Controlled Trial Efficacy and safety of paclitaxel nano-dispersion concentrate for injection (PICN) in subjects with metastatic breast cancer: A randomized, open label, active controlled, comparative, parallel group, and multi-centric study. Efficacy and safety of paclitaxel nano-dispersion concentrate for injection (PICN) in subjects with metastatic breast cancer: A randomized, open label, active controlled, comparative, parallel group, and multi-centric study. 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) CLR_10_13 Designation Affiliation Protocol Number Details of Principal Investigator Dr D Raghunadharao Professor and Head of Medical Oncology Department Nizams Institute of Medical Sciences Panjagutta ANDHRA PRADESH Phone Fax Designation Affiliation rdigumarti@gmail.com Details Contact Person (Scientific Query) Dr Shravanti Bhowmik Phone Fax Designation Affiliation Medical Advisor - Clinical Research Sun Pharma Advanced Research Co Ltd 17/B, Mahal Industrial Estate, Mahakali Caves Road Andheri (East) shravanti.bhowmik@sparcmail.com Details Contact Person (Public Query) Dr Shravanti Bhowmik Phone Medical Advisor - Clinical Research Sun Pharma Advanced Research Co Ltd 17/B, Mahal Industrial Estate, Mahakali Caves Road Andheri (East) page 1 / 7

2 Source of Monetary or Material Support Primary Sponsor Details of Secondary Sponsor Countries of Recruitment Sites of Study Fax > Nil Type of Sponsor List of Countries of Principal Investigator Source of Monetary or Material Support Primary Sponsor Details Sun Pharma Advanced Research Company Ltd 17/B, Mahal Industrial Estate, Mahakali Caves Road, Andheri-E, , Maharashtra,. Pharmaceutical industry-n of Site Site Phone/Fax/ Dr. Ashok Vaid Medanta-The Medicity, Cancer Institute, Division of Medical Oncology and Haematology,, Sector-38, Dr. Raghunathrao Digumarti Nizam's Institute of Medical Sciences, Dr. P. P. Bapsy Apollo Hospitals -, Dr. T. Raja Dr Shekhar Patil Apollo Speciality Hospital, Institute of Oncology Department of Medical Oncology,,Punjagutta ANDHRA PRADESH 154/11 Opp IIM B,,Bannerghatta Road, , Padma Complex,,Anna Salai, TAMIL NADU rg m #8, HCG Tower 4, P Kalinga Rao Road,Sampangi Rama Nagar, mail.com 7, Karnataka. Dr. Anand Pathak Cancer Care Clinic, 5th Floor, Vasant Sheela Towers, Lokmat Square,,Dhantoli, Nagpur Dr. Smita Gupte Cancer Clinic, Shreevardhan complex, Near Panchsheel Square,, Wardha Road, Nagpur page 2 / 7

3 Dr. Chetan Deshmukh Dr Govind Babu Dr S Ganapati Raman Deenanath Mangeshkar Hospital Research Centre Department of Medical Oncology, Kidwai Memorial Institute of Oncology Department of Medical Oncology, Kumaran Hospital Pvt. Ltd. Erandawane, Pune Dr M H Marigowda Road,,Hosur Road, , E.V.R Periyar Salai, Kilpauk, , Tamil Nadu. TAMIL NADU Dr Kirti Patel GCRI The Gujarat Cancer Society, Civil Hospital campus, Asarwa, Ahmedabad , Gujarat. Dr Ravi Kumar Saxena Global Hospitals, /1 to 4,Lakdi-ka-pool ANDHRA PRADESH Dr. Niraj Bhatt Dr. Ashish Bakshi Dr. Minish Jain Dr. Chiramana Haritha Kailash Cancer Hospital & Research Centre Kaushalya Medical Foundation Trust Hospital, KEM Hospital Research Centre, M. S. Patel Cancer Center, Muni Seva Ashram,,Ta. Vaghodia, , Ganesh Wadi,,Panchpakhadi Thane Bhanu Koyaji Building, Sardar Moorliar Road,,Rasta Peth, Pune Shree Krishna Hospital,, Gokal Nagar, Dr. Poonam Patil Manipal Hospital, Medical Oncology,, Airport Road Dr. G S Bhattacharyya Orchid Nursing Home P-14, C-17 Road, Phoolbagan Kolkata WEST BENGAL Dr. Shailesh Bondarde Shatabdi Super Speciality Hospital, Suyojit City Centre, Opp Mahamarg Bus Stand,, Naka, Nashik drchetandeshmukh@re diffmail.com kgbtrials@yahoo.co.in kumaranhospitals@hot mail.com contact@gcriindia.org ravikumar1960@hotmai l.com nirajbhatt1974@gmail.c om, Bakshi10a@gmail.com, drminishjain@yahoo.in ritu80@rediffmail.com poonampatil@yahoo.co m docgsbhattacharyya@g mail.com shaileshbondarde@yah oo.com page 3 / 7

4 Details of Ethics Committee Dr. Jyoti Bajpai Dr Subramanian Sundaram Tata Memorial Hospital, Dr. E Borges Road,,Parel , V S Hospital 13, East Spur tank road, Chetpet TAMIL NADU dr_jyotibajpai@yahoo.c o.in drss@vshospitals.com Dr Chirag Desai Vedanta clinic Hemato-oncology clinic, Vendanta Institute of Medical Sciences, Near chiragdesai.oncology@ Samved Hospital, gmail.com Commerce college road Ahmadabad GUJARAT of Committee Approval Status Date of Approval Is Independent Ethics Committee? Central Medical Research Ethics committee, Nagpur COMSARTs, Independent Ethics Committee, Kandivali (East), CRRT-Kumaran Hospital Ethics Committee, Ethics Committee of Care Institute of Medical Sciences, Ahmedabad Approved 19/07/2010 No Approved 26/06/2010 Yes Approved 23/05/2011 No Approved 02/11/2010 No Ethics Committee of Approved 08/09/2010 No KEM Hospital Research Centre Apollo Hospitals, Kaushalya Medical Foundation Trust Hospital, Thane Nizams Institute of Medical Sciences, GCRI Ethics Committee, Ahmedabad Global Health Concern Ethics Committee Nagpur Human Research H. M. Patel Centre for Medical Care and Education, Karamsad Approved 15/12/2010 No Approved 18/08/2010 No Approved 31/12/2010 No Approved 29/01/2011 No Approved 27/07/2010 No Approved 31/08/2010 No Institutional Ethical Approved 29/10/2010 No page 4 / 7

5 Regulatory Clearance Status from DCGI Health Condition / Problems Studied Intervention / Comparator Agent Inclusion Criteria Review Board, Orchid Nursing Home, Kolkata Institutional ethics committe, shatabdi hospital, Nashik Committee, Apollo Hospitals,. Committee, Deenanath Mangeshkar Hospital, Pune Committee, Global Hospitals, Committee, Manipal Hospital Committee, Medanta-The Medicity Committee, Tata Memorial Hospital, Medical Ethics Committee, Kidwai Memorial Institute of Oncology, Banglore The Madras Research Center, The HCG-Central Status Approved/Obtained Health Type Patients Approved 11/08/2010 No Approved 27/09/2010 No Approved 29/07/2010 No Approved 20/10/2010 No Approved 21/01/2011 No Approved 02/11/2010 No Approved 01/08/2011 No Approved 15/12/2010 No Approved 27/12/2010 No Approved 15/02/2011 No Date No Date Specified Condition Female subjects with age 18 to 70-years inclusive, with histologically or cytologically confirmed metastatic breast cancer Type Details Intervention Comparator Agent Age From Age To Gender Details Paclitaxel nano-dispersion concentrate for injection (PICN) Marketed Paclitaxel nano-dispersion Year(s) Year(s) Female Inclusion Criteria 3 weekly; Cycles till disease progression/ toxicity 3 weekly; Cycles till disease progression/ toxicity Histologically or cytologically confirmed metastatic breast cancer is candidate for single agent paclitaxel in accordance with standard of care. Female subjects aged 18 to 70 years; Performance status less than or equal to 2 on the ECOG page 5 / 7

6 Exclusion Criteria Method of Generating Random Sequence Method of Concealment Blinding/Masking Details Computer generated randomization Other Open Label performance scale Estimated life expectancy of at least 12-weeks; Measurable disease as per RECIST Version 1.1; Adequate organ and immune system function as indicated by the laboratory values, obtained? 2 weeks prior to dosing; Subjects must have received prior chemotherapy as adjuvant therapy or for metastatic disease. Any chemotherapy (except palliative bisphosphate therapy for bone pain), major surgery, or irradiation must have been completed at least 4-weeks before enrollment in this study (6-weeks for Mitomycin C or nitrosurea); subjects must have recovered from all toxicities incurred as a result of previous therapy; If subject has received taxanes as adjuvant therapy, she must not have relapsed with breast cancer within 48-weeks of completing adjuvant taxane therapy; Prior hormonal therapy for breast cancer must have been completed at least 2-weeks before enrollment in this study; Women of child bearing potential practicing an acceptable method of birth control or postmenopausal for at least 1 year, surgically sterile with a negative urine pregnancy test; Willing to participate and give written informed consent. Exclusion Criteria Any malignancy within past 5-years, except non-melanoma skin cancer, cervical intraepithelial neoplasia (CIN), or in situ cervical cancer (CIS); The only evidence of metastasis is lytic or blastic bone lesions or pleural effusion or ascites; Known hypersensitivity to study drugs or its excipients (Cholesteryl sulfate, Caprylic acid, Polyvinylpyrrolidone, Ethanol or Polyethylene glycol); Treatment with any investigational agents within 30-days of study entry; Presence of clinically evident active CNS metastases, including leptomeningial involvement, requiring steroid or radiation therapy; Pre-existing peripheral neuropathy ; Any other severe concurrent disease which in the judgment of the investigator would make the subject inappropriate for entry into this study; Taxanes received for metastatic breast cancer; Presence of pleural/ascitic fluid Primary Outcome Outcome Timepoints To evaluate safety and efficacy of PICN (Paclitaxel injection concentrate for nanodispersion) After 6 cycles for all patients. Secondary Outcome Outcome Timepoints Target Sample Size PFS (Progression free survival) Total Sample Size=180 Sample Size from =180 Phase of Trial Phase 2/ Phase 3 Date of First Enrollment () Date of First Enrollment (Global) Estimated Duration of Trial 01/08/2010 No Date Specified Years=2 Months=0 Days=0 At the end of study page 6 / 7

7 Powered by TCPDF ( Recruitment Status of Trial (Global) Recruitment Status of Trial () Publication Details Brief Summary Completed None The study has been completed. page 7 / 7