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Clinical Trial Details (PDF Generation Date :- Fri, 03 Sep 2021 12 PDF of Trial CTRI Website URL - http://ctri.nic.in Clinical Trial Details (PDF Generation Date :- Thu, 23 Sep 2021 22:25:14 GMT) CTRI Number CTRI/2014/09/005042 [Registered on: 22/09/2014] - Trial Registered Prospectively Last Modified On 06/10/2015 Post Graduate Thesis No Type of Trial Interventional Type of Study Biological Study Design Randomized, Parallel Group, Active Controlled Trial Public Title of Study A Phase III study to compare the safety and efficacy of Bevacizumab against Avastin™ in Patients with Non-Small Cell Lung Cancer Scientific Title of A Prospective, Comparative, Open Label, Randomized, Multicentric, Phase III study to compare the Study safety and efficacy of Bevacizumab of Intas Pharmaceuticals Limited against Avastin™ in Patients with Unresectable or Metastatic Non-Squamous Non-Small Cell Lung Cancer Secondary IDs if Any Secondary ID Identifier 476-13; Version 02; 10 Mar 14 Protocol Number Details of Principal Details of Principal Investigator Investigator or overall Name Harshit Shah Trial Coordinator (multi-center study) Designation Ass.Project Manager Affiliation Lambda Therapeutic Research Ltd Address Lambda Therapeutic Research Ltd, Plot No. 38, Near Silver Oak Club, S.G. Highway, Gota Ahmadabad GUJARAT 380061 India Phone 07940202067 Fax 07940202021 Email [email protected] Details Contact Details Contact Person (Scientific Query) Person (Scientific Name Dr Arpit Prajapati Query) Designation Manager Affiliation Lambda Therapeutic Research Ltd Address Lambda Therapeutic Research Ltd, Plot No. 38, Near Silver Oak Club, S.G. Highway, Gota Ahmadabad GUJARAT 380061 India Phone 07940202322 Fax 07940202021 Email [email protected] Details Contact Details Contact Person (Public Query) Person (Public Query) Name Harshit Shah Designation Ass.Project Manager Affiliation Lambda Therapeutic Research Ltd Address Lambda Therapeutic Research Ltd, Plot No. 38, Near Silver Oak Club, S.G. Highway, Gota Ahmadabad GUJARAT 380061 India page 1 / 9 PDF of Trial CTRI Website URL - http://ctri.nic.in Phone 07940202067 Fax 07940202021 Email [email protected] Source of Monetary or Source of Monetary or Material Support Material Support > Intas Pharmaceuticals Ltd. Primary Sponsor Primary Sponsor Details Name Intas Pharmaceuticals Ltd Address Intas Pharmaceuticals Limited,Bio-Pharma Division, Plot No.423/P/A, Sarkhej-Bavla Highway, Moraiya, Tal: Sanand,Ahmedabad-382213, Gujarat, India. Type of Sponsor Pharmaceutical industry-Indian Details of Secondary Name Address Sponsor NA NA Countries of List of Countries Recruitment India Sites of Study Name of Principal Name of Site Site Address Phone/Fax/Email Investigator Dr Niharika Panda Acharya Harihar Dept. of Radiation 9437487842 Regional Cancer Oncology, Medical Centre Road, niharika.panda@yahoo. Mangalabag-753007 com Cuttack ORISSA Dr Lalit Kumar All India Institute of Room No. 234, 9811446828 Medical Sciences Department of Medical Oncology, Dr. [email protected] B.R.A.R.C.H, All India Institute of Medical Sciences- 110029 New Delhi DELHI Dr Arun Philip Amrita Institute of Department of 9744528829 Medical Sciences Oncology, Room No. 2, AIMS, Ponekkara [email protected] PO-682041 ta.edu Ernakulam KERALA Dr Jayanti G Patel Apple Hospital Udhna Darwaja, Ring 9825121347 Road-395002 Surat [email protected] GUJARAT m Dr Kirankumar Puna B. J. Govt. Medical Dept. of Surgery, Pune 9823949126 Jadhav College & Sassoon Station-411001 General Hospital Pune [email protected] MAHARASHTRA Dr Kunjahari Medhi Batra Hospital & 1, Tughlakabad 9818884856 Medical Research Institutional Area, Centre Mehrauli Badarpur [email protected] Road-110062 South West DELHI Dr KR Madhava BGS Global Hospitals BGS Health & 9686724368 Education City, Dept. of Cancer Institute, #67, [email protected] page 2 / 9 PDF of Trial CTRI Website URL - http://ctri.nic.in Uttarahalli Road, m Kengeri-560060 Bangalore KARNATAKA Dr V Satya Suresh Attili BIBI General Hospital Department of 9246243034 and Cancer Centre Radiotherapy, 16-3-991/1/C, Govt. [email protected] Printing Press Road, Malakpet-500024 Hyderabad ANDHRA PRADESH Dr Gururaj Deshpande City Cancer Centre 33-25-33, Ch. Venkata 9603548404 Krishnayya Street, Suryarao Pet, drgururajdeshpande@g Vijaywada-520002 mail.com Krishna ANDHRA PRADESH Dr Rajnish Vasant Curie Manavata Cancer Opp. Mahamarg, Bus 9823061929 Nagarkar Centre Stand, Mumbai Naka-422004 drraj@manavatacancer Nashik centre.com MAHARASHTRA Dr Srinivasan Dr. Kamakshi Memorial No. 1, Radial Road, 9444435489 Varadarajan Hospital Pvt. Ltd. Pallikaranai-600100 Chennai [email protected] TAMIL NADU om Dr Srinivasan Krishnan Dr. Rai Memorial #526, Century Plaza, 9444896010 Medical Centre Anna Salai, Teynampet-600018 [email protected] Chennai TAMIL NADU Dr Shashidhara H P HCG Bangalore Department of 8040206058 Institute of Oncology Oncology, #8, P. Kalinga Rao Road, shashidharahp@rediffm Sampangi Ram ail.com Nagar-560027 Bangalore KARNATAKA Dr Bhavesh Parekh HCG Cancer centre Department of 9825034353 Radiography, Sola-Science City bhaveshdm1@hotmail. Road, Near Sola com Bridge, S.G. Highway-380060 Ahmadabad GUJARAT Dr Kakali Choudhary Health Point 21, Prannath Pandit 9883083052 Multispecialty Hospital street (opp. Lansdowne padmapukur)- 700025 mailkakalichoudhury@g Kolkata mail.com WEST BENGAL Dr Siddhartha Basu IPGMER and SSKM #244, AJC Bose 9874166240 Hospital Road-700020 Kolkata siddharthabasu24@gm WEST BENGAL ail.com Dr Vijay Kumar King George Medical Department of Surgical 9935383666 University (Erstwhile Oncology, CSMMU) Chowk-226003 [email protected] page 3 / 9 PDF of Trial CTRI Website URL - http://ctri.nic.in Lucknow om UTTAR PRADESH Dr Suresh Babu MC Life Care Hospital Building No. 23/24, Om 9343262589 Complex, 20th Main, Gangothri Circle, BTM sureshbabu_mc@yaho 1st Stage-560029 o.co.in Bangalore KARNATAKA Dr Chinmay Basu Netaji Subhash 16A, Park Lane-700016 9830114880 Chandra Bose Cancer Kolkata Research Institute WEST BENGAL [email protected] Dr Rakesh kapoor Post Graduate Institute Department of 9872648344 of Medical Education & Radiotherapy, Room Research No. 3, Sector-12- [email protected] 160012 Chandigarh CHANDIGARH Dr Adwaita Gore Prince Aly Khan Aga Hall, Nesbit Road, 9821262618 Hospital Mazagaon-400010 Mumbai [email protected] MAHARASHTRA Dr Ajay Sharma Rajiv Gandhi Cancer Department of 9999379838 Institute and Research Radiology, Room no. 1, Centre Sector-5,Near West [email protected] Rohini Metro Station, om Rohini-110085 West DELHI Dr G Raja Rajiv Gandhi Dept. of Radiation 9841107677 Government General Oncology, E.V.R. Hospital & Madras Periyar Salai, Park [email protected] Medical College Town- 600003 Chennai TAMIL NADU Dr Choondal Devan Regional Cancer Department of 9447882149 Sivanandan Centre, Medical College Radiation Oncology, Campus Regional Cancer sivanandancd@hotmail. Centre, Medical College com Campus- 695011 Thiruvananthapuram KERALA Dr Richa Chauhan S.S. Hospital and Doctors Colony, Malahi 9431021001 Research Centre Pakri Chowk, Kankarbagh-800020 [email protected] Patna om BIHAR Dr Ghanashyam Sparsh Hospitals & A/407, Sahid Nagar- 9937500878 Biswas Critical Care Pvt. Ltd. 751007 Khordha [email protected] ORISSA Dr Kuntegowdennahalli Srinivasam Cancer No. 236/1, Vijayashree 9448055949 Chinnagiriyappa Care Hospitals India Layout, Arekere, Lakshmaiah Pvt. Ltd. Bannnerghatta Main [email protected] Road-560076 Bangalore KARNATAKA Dr Tanveer Mohibbhai Unique Hospital Opp. Kiran Motor, Nr. 9909918887 Maksud Multispecialty & Canal, Civil Hospital page 4 / 9 PDF of Trial CTRI Website URL - http://ctri.nic.in Research Institute Char Rasta - Sosyo tanveermaksud@yahoo Circle Lane, Off. Ring .com Road-395002 Surat GUJARAT Details of Ethics Name of Committee Approval Status Date of Approval Is Independent Ethics Committee Committee? Acharya Harihar Submittted/Under No Date Specified No Regional Cancer Review Centre Institutional Ethics Committee (AHRCC-IEC),Dr. Niharika Panda Apple Hospital Ethics Approved 20/10/2014 No Committee,Dr. Jayanti G. Patel BIBI Institutional Ethics Approved 18/02/2015 No Committee,Dr. V. Satya Suresh Attili Dr. Kamakshi Memorial Approved 13/10/2014 No Hospital Institutional Ethics Committee, Dr. Venkatesan Srinivasan Ethics committee, All Submittted/Under No Date Specified No India Institute of Review Medical Sciences,Dr. Lalit Kumar Ethics Committee, Approved 07/10/2014 No Netaji Subhash Chandra Bose Cancer Research Institute, Dr. Chinmay Basu Ethics Approved 08/09/2014 No Committee,Unique Hospital Multispecialty & Research Institute, Dr. Tanveer Maksud HCG Multi Specialty Approved 16/06/2015 No Ethics Committee,Dr. Ashish Kaushal HCG-Central Ethics Approved 28/02/2015 No Committee, Dr. Shekar Patil Health Point Ethics Approved 11/09/2014 No Committee,Dr.Dr. Kakali Choudhary Human Ethics Submittted/Under No Date Specified No Committee, Regional Review Cancer Centre, Dr. Choondal Institutional Ethics Approved 05/02/2015 No Committee of B. J. Govt. Medical College, Dr. Kirankumar Puna Jadhav Institutional Ethics Approved 24/09/2014 No Committee Sparsh page 5 / 9 PDF of Trial CTRI Website URL - http://ctri.nic.in Hospital, Dr. Ghanashyam Biswas Institutional Ethics Approved 06/02/2014 No Committee, Prince Aly Khan Hospital, Dr. Adwaita Gore Institutional Ethics Approved 11/10/2014 No Committee,City Cancer Centre, Dr. M. Gopichand Institutional Ethics Submittted/Under No Date Specified No Committee,Dr. Arun Review Philip Institutional Ethics Approved 15/09/2015 No Committee,Dr. G. Raja Institutional
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