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1 Clinical Trial Details (PDF Generation Date :- Tue, 16 Apr :14:23 GMT) CTRI Number CTRI/2010/091/ [Registered on: 24/01/2011] - Last Modified On 07/03/2019 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 A clinical trial to study the effects of two drugs, ozarelix and goserelin in men with prostate cancer An International, Multi-Center, Open Label, Randomized Study Assessing the Safety and Efficacy of a Monthly Dosing Regimen of Ozarelix versus Goserelin Depot (Zoladex) in Men with Prostate Cancer 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) NCT SPI Designation Affiliation ClinicalTrials.gov Protocol Number Details of Principal Investigator Dr Sunita Rajadhyaksha Phone Fax Designation Affiliation OncoRx Pharma Pvt Ltd, 85 Mittal Chambers, Opp Inox Theater, Nariman Point, sunita.rajadhyaksha@oncorxindia.com Details Contact Person (Scientific Query) Dr Sunita Rajadhyaksha Medical Director Phone Fax Designation Affiliation OncoRx Pharma Pvt Ltd, 85 Mittal Chambers, Opp Inox Theater, Nariman Point, sunita.rajadhyaksha@oncorxindia.com Details Contact Person (Public Query) Dr Sunita Rajadhyaksha OncoRx Pharma Pvt Ltd, 85 Mittal Chambers, Opp Inox Theater, Nariman Point, page 1 / 6

2 Source of Monetary or Material Support Primary Sponsor Details of Secondary Sponsor Countries of Recruitment Sites of Study Phone Fax > NIL Type of Sponsor OncoRx Pharma Pvt Ltd List of Countries United States of America of Principal Investigator Source of Monetary or Material Support Primary Sponsor Details Spectrum PharmaceuticalsInc 157 Technology Drive, Irvine CA 92618Phone: (949) Facsimile:(949) Pharmaceutical industry-global Dr Sanjay Garg khushi maternity and surgical centre Dr Shivadeo S Bapat Ratna Memorial Dr Ajit Saxena Dr Apul Goel Dr Chandra Shekhar Thatte Dr Kim Mammen Dr Kapil Pankajbhai Thakkar 85,Mittals Chambers,Nariman Point, of Site Site Phone/Fax/ Ajit Surgical and Maternity Centre Chhatrapati Shahuji Maharaj Medical University Choithram & Research Centre Christian Medical College and Excel, An Advanced Urology and Laparoscopy Centre G3,3/7,Sector II, Rajinder Nagar, Ghaziabad sanjayuro@gmail.com UTTAR PRADESH 968, Senapati Bapat Road, Pune Pune shivadeo@bapats.in X-9, Sector 12, Noida , Uttar Pradesh Ghaziabad ajitsaxena@hotmail.co UTTAR PRADESH m Lucknow Lucknow UTTAR PRADESH Manik Bagh Road, Indore Indore MADHYA PRADESH Ludhiana,Punjab Ludhiana PUNJAB 8-15, 3rd Floor, Sheetal Shopping Square,(Old LB Cinema), Ghod Dod-Bhatar Road Junction, Surat Surat goelapul1@rediffmail.c om csthatte@gmail.com kjmammen@gmail.com kapilthakkar@gmail.co m Dr Anil Mohanlal Excel Urology Centre Opp. Basant page 2 / 6

3 Bradoo Dr Madan Mohan Bansal Dr Raghunath S K Dr Hemang Baxi Dr Suresh H Advani Dr Mahesh Desai Dr Rajendra Kashinath Shimpi Fortis Escorts HCG Bangalore Institute Of Oncology HCG Medi-Surge s Jaslok & Research Centre Muljibhai Patel Urological Noble Cinema,Dr. C. G. Road, Chembur, (Suburban) Jawahar Lal Nehru Marg, Malviya Nagar, Jaipur Jaipur RAJASTHAN No 8, HCG Towers, P. Kalinga Rao Road, Sampangi Rama Nagar, Bangalore Bangalore KARNATAKA 1,Nr. Mithakhali Six Roads, Ellisbridge, Ahmedabad Department of Medical Oncology,15, Dr G. Deshmukh Marg, Dr. Virendra Desai Road, Nadiad , Magarpatta City R oad,hadapsar,pune Pune Dr Shrenik Shah Rushabh Uro 2nd floor, Heritage Plaza, Opp. Gurukul Tower, Drive in Road, Ahmedabad Dr Janak Desai Samved Urology Department, On Stadium Circle to Commerce College Six Roads, Navrangpura, Ahmedabad Dr Hemant Rangnath Pathak TNMC & BYL Nair Department of Urology,Second Floor,College Building, Central (Suburban) bradooa@gmail.com drmmbansal@yahoo.co.in drraghunathsk@yahoo. com bakshihemang@yahoo. co.in shadvani2000@yahoo. com mrdesai@mpuh.org rajendrakshimpi@gmail.com drshreniks@gmail.com drjanak@samvedurolog y.com hemanturologist@gmail.com Dr Divakar Dalela Uro-Health Research Center2/503, Vikas page 3 / 6

4 Details of Ethics Committee Dr N K Mohanty Dr Kalyan Kumar Sarkar Center Nagar, Lucknow Lucknow UTTAR PRADESH Vardhaman Mahavir Medical College And Safdarjung Woodland Medical Centre Limited New Delhi New Delhi DELHI 8/5, Alipore Road, Kolkata Kolkata WEST BENGAL drdalela@sify.com nayankm@yahoo.co.in kksarkar@gmail.com of Committee Approval Status Date of Approval Is Independent Ethics Committee? for Ajit surgical and maternity centre for Excel, An Advanced Laparoscopy and Urology Centre for Excel Urological Centre for Khushi Maternity and surgical hospital for Rushabh Uro Ethical Committee Safdarjung Ethics Committee of B.Y.L. Nair Charitable And T.N. Medical College Ethics Committee Samved HCG - Central Ethics Committee HCG Medi-Surge Ethics Committee Independant Ethics Committee for Uro-Health Research Centre Institution Ethics committe, Fortis Escort committee, Chhatrapati Shahuji Maharaj Medical University committee, Choithram Approved 10/11/2010 Yes Approved 23/05/2011 Yes Approved 23/05/2011 Yes Approved 10/11/2010 Yes Approved 30/08/2011 Yes Approved 18/10/2010 No Approved 28/01/2011 No Approved 09/10/2010 No Approved 15/03/2011 No Approved 15/10/2011 No Approved 19/03/2011 Yes Approved 18/03/2011 No Approved 21/02/2011 No Approved 10/06/2011 No page 4 / 6

5 Regulatory Clearance Status from DCGI Health Condition / Problems Studied Intervention / Comparator Agent Inclusion Criteria Exclusion Criteria Method of Generating Random Sequence Method of Concealment Blinding/Masking and reseacrh centre Institutional ethics committee, CMC and, Ludhiana committee, Muljibhai Patel society for research in Nephro-urology Committee, Noble committee, Woodlands Medical centre Jaslok and research centre Ethics committee Maharashtra Medical Research Society Status Approved 27/01/2011 No Approved 28/06/2011 No Approved 26/10/2010 No Approved 16/02/2011 No Approved 09/08/2011 No Approved 13/04/2011 No Date Approved/Obtained 27/12/2010 Health Type Patients Condition Malignant neoplasm of prostate Type Details Intervention ozarelix Two SC injections of ozarelix 65 mg in the abdomen on Day 1 (LLQ and RLQ), followed by a SC injection of 65 mg of Ozarelix (abdomen LLQ) on day 8 and will receive 2 additional SC injections of Ozarelix on days 28 and 56 (alternating injection sites). Comparator Agent Goserelin One 3.6 mg SC injection in the abdomen (LLQ or RLQ), followed by a 3.6 mg SC injection on Days 28 and 56 (alternating injection sites). Age From Age To Gender Details Details Year(s) Year(s) Male Computer generated randomization Centralized Open Label Inclusion Criteria Patients, aged 18 years or older, with histologically proven prostate cancer of any stages, for whom endocrine treatment is indicated. Exclusion Criteria Any hormone therapy prior to study entrance page 5 / 6

6 Powered by TCPDF ( Primary Outcome Outcome Timepoints Percentage of patients with testosterone less than or equal to 0.5ng/mL in each group Day 28 through Day 84, Secondary Outcome Outcome Timepoints 1)Testosterone surge 2)Percentage of patients with less than or equal to 0.5 ng/ml 3) median time to reach 50% suppression of baseline PSA level 4) Safety 1) during the first two weeks of treatment 2) at Day 3 Target Sample Size Phase of Trial Phase 2 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 Total Sample Size=214 Sample Size from =100 01/01/ /10/2010 Years=1 Months=0 Days=0 Completed Completed Information regarding use or publication of study-related information will be provided to the Investigator in the Clinical Trial Agreement. Study is conducted in USA and. The aim of this study is to assess the safety and efficacy of a monthly regimen of ozarelix administered SC versus Goserelin depot administered SC in men with Prostate Cancer. This is an international, multi-center, randomized, open label 84 days study. Men who are at least 18 years of age or older, with histologically proven prostate cancer of all stages, in whom endocrine treatment is indicated will be eligible for study entry. Prospective study subjects will undergo screening procedures. Approximately 214 eligible patients will enter the study. Patients will be randomized in a 1:1 ratio to one of two treatment arms (Ozarelix or Goserelin). Eligible patients randomized to the ozarelix group will receive two SC injections of ozarelix 65 mg in the abdomen on Day 1 (LLQ and RLQ), followed by a SC injection of 65 mg of Ozarelix (abdomen LLQ) on day 8 and will receive 2 additional SC injections of Ozarelix on days 28 and 56 (alternating injection sites). Eligible patients randomized to Goserelin will receive one 3.6 mg SC injection in the abdomen (LLQ or RLQ), followed by a 3.6 mg SC injection on Days 28 and 56 (alternating injection sites). From we are recruiting 100 patients, and date of enrollment is 25 Jan 2011 ( anticipated date of enrollment) page 6 / 6