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1 Clinical Trial Details (PDF Generation Date :- Fri, 08 Mar :26:40 GMT) CTRI Number Last Modified On 14/02/2013 Post Graduate Thesis Type of Trial Type of Study Study Design Public Title of Study Scientific Title of Study CTRI/2011/04/ [Registered on: 13/04/2011] - Trial Registered Prospectively No Interventional Drug Single Arm Trial To study how efficacious and safe Bicalutamide is in prostate cancer patients A Phase IV, Single Arm, Multi-Centric, Non-Comparative, Study to Evaluate Efficacy, Safety And Tolerability Of Bicalutamide In Advanced and/or Metastatic 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) CP/18/10 Protocol Number Details of Principal Investigator Phone Fax Ketaki Nursing Home and Urology Center, Beside Suretech Hospital, Dhantoli, NIL sadashivbhole@gmail.com Details Contact Person (Scientific Query) Dr Nitin Joshi Phone Fax Associate Director Medical Affairs & Safety Associate Director Medical Affairs & Safety Karmic Lifesciences, 802, Building No. 3, Raheja Mind Space(SEZ), Plot No. 3, TTC Industrial Area, Airoli, Navi Mumbai NIL Thane nitin.joshi@karmiclifesciences.com Details Contact Person (Public Query) Phone Ketaki Nursing Home and Urology Center, Beside Suretech Hospital, Dhantoli, NIL page 1 / 5

2 Source of Monetary or Material Support Primary Sponsor Details of Secondary Sponsor Countries of Recruitment Sites of Study Fax Source of Monetary or Material Support > Cipla Ltd, Bellasis Road, Mumbai Central, Mumbai, Phone Fax Cipla Ltd Primary Sponsor Details Bellasis Road, Mumbai Central, Mumbai, Phone: (022) Fax: (022) Type of Sponsor NIL List of Countries of Principal Investigator Dr Dillip Kumar Aggarwalla Dr Tanveer Maksud Pharmaceutical industry-n NIL of Site Site Phone/Fax/ Acharya Harihar Regional Cancer Centre Bharat Cancer Hospital and Research Institute Acharya Harihar Regional Cancer Centre, Mangalbag Road, Cuttack , Orissa, Cuttack ORISSA Bharat Cancer Hospital and Research Institute, Opp. HP Petrol Pump, Surat Bardoli Road, Saroli, Surat , Gujarat, Surat GUJARAT Dr G N Patel Jeevandip Hospital Surgical Oncologist, Jeevandip Hospital, AYUSH Doctor House, 302, 3rd Floor, Near Param Doctor House, Near Resham Bhuvan, Surat , Gujarat, Surat GUJARAT Dr Ghanashyam Biswas Ketaki Nursing Home and Urology Center Sparsh Hospitals and Critical Care, Ketaki Nursing Home and Urology Center Beside Suretech Hospital, Dhantoli, Sparsh Hospitals and Critical Care, A/ 407, Sahid Nagar, Bhubaneshwar dillip_ag@yahoo.com tanveermaksud@yahoo.com gnonco@gmail.com sadashivbhole@gmail.c om drgbiswas@yahoo.com page 2 / 5

3 Details of Ethics Committee Regulatory Clearance Status from DCGI Health Condition / Problems Studied Intervention / Comparator Agent Inclusion Criteria 007, Orissa, Khordha ORISSA of Committee Approval Status Date of Approval Is Independent Ethics Committee? Committee for Acharya Harihar Regional Cancer Centre Committee for Bharat Cancer Hospital and Research Institute Committee for Jeevandip Hospital Committee for Sparsh Hospitals and Critical Care Global Health Concern Ethics Committee for Ketaki Nursing Home and Urology Center Status Health Type Patients Approved 02/08/2011 Yes Date No Date Specified Condition Advanced and/or Metastatic Prostate Cancer Type Details Intervention Bicalutamide Tablet Bicalutamide 50 mg Tablet once daily for duration of 180 days. Comparator Agent NIL NIL Age From Age To Gender Details Year(s) Year(s) Male Inclusion Criteria 1.A potential subject willing to give written informed consent on his own or LAR/Impartial witness in case of an illiterate subject 2.Subjects entering the study should be greater than or equal to 18 Years and less than 80 Years of age. 3.Subjects entering the study should be clinically and histopathologically confirmed as diagnosed with advanced / metastatic prostate cancer. 4.Subjects participating in the study should agree to use effective contraception, in order to avoid female partner pregnancy. 5.Subjects participating in the study should have a baseline Serum PSA titre of greater than or equal to 10 ng/ml. 6.Subjects who have undergone prior radiotherapy and/or surgery can be included in the study provided, the radiotherapy and/or surgery has occurred at least 4 weeks prior to the initiation of treatment with the study drug. page 3 / 5

4 7.Subjects participating in the study should have adequately controlled diabetes or cardiovascular disease, if suffering from any. 8.Subjects entering the study should have Hematology Profile specifications as follows: Hemoglobin (Hb) greater than 9.0 gm / dl, Platelete greater than or equal to 1, 00,000/ cumm. 9.Subjects entering the study should have clinical chemistry specifications as follows: Hepatic Profile (Bilirubin, Total Bilirubin less than or equal to 1.5 (times ULN), Alanine Transaminase (ALT) less than or equal to 2.5 times ULN, Aspartate Transaminase (AST) less than or equal to 2.5 times ULN, and Renal Functions (Serum Creatinine less than or equal to 1.5 times (ULN). 10.ECOG Performance Status of less than or equal to Subjects participating in the study should have a life expectancy of at least 6 months as per the investigators discretion. 12.Subjects who are surgically castrated will be included in the study. 13.Potential subjects should be willing to comply with the study procedures. Exclusion Criteria Details Exclusion Criteria 1.Subjects with any clinically significant lab test and co-morbidity including any concurrent disease that could affect the patients safety, as per the Investigators discretion. 2.Subjects with known Central Nervous System (CNS) metastasis, having a clinically stable disease of at less than 8 weeks prior to the administration of the study drug (A patient with known CNS metastasis and having a clinically stable disease of 8 weeks or more can be included in the study.) 3.Subjects under concurrent therapy with any other non-protocol anti-cancer therapy, including hormonal therapy or any other systemic anti-cancer therapy. 4.Subjects under treatment for ANY Acute Urinary Tract Infection (UTI) or any other active clinically significant systemic infections. 5.Subjects who are known to be hypersensitive to the study drug or to any of the excipients. 6.Subjects who have been on the investigational drug within 30 days, prior to screening. Method of Generating Random Sequence Method of Concealment Blinding/Masking Open Label Primary Outcome Outcome Timepoints Percentage reduction in circulating PSA levels as compared to baseline in patients of Prostate Cancer undergoing treatment with Bicalutamide. Secondary Outcome Outcome Timepoints 1.Percentage of subjects, who achieve complete or partial response as compared to baseline, assessed for overall response as per RECIST Version 1.1 using imaging studies (CT/MRI) at Visit 4(Day90) and Visit 7 (Day180). 2.Percentage of subjects who achieve Time to progression (TTP) defined as the time from the start of treatment to the date of documented progression, assessed for overall response as per RECIST Version 1.1 using imaging studies page 4 / 5

5 Powered by TCPDF ( Target Sample Size Phase of Trial Phase 4 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 (CT/MRI) at Visit 4(Day90) and Visit 7 (Day180). 3. To evaluate Progression Free Survival (PFS) defined as; the time from the start of treatment to the end of the treatment with no worsening of the disease condition. 4.Percentage reduction in Bone Marker Levels (Bone Fraction Serum Alkaline Phosphatase and Serum Calcium) at visit 4(day 90) and Visit 7(day 180) compared to baseline values 1.Quality of Life using VAS for Pain. At Visit 3 (Day 60), visit 5 (Day120), visit 7 (Day180) and visit 8 (Day195) 1.Safety of the study drug will be estimated from type, number, frequency and percentage of subjects with AE(s) 7.Treatment Emergent Adverse Events (TEAE defined as an AE which is definitely or probably related to study medication) as per Common Terminology Criteria for Adverse Events (CTCAE), Version Total Sample Size=36 Sample Size from =36 26/05/2011 No Date Specified Years=1 Months=3 Days=0 Completed Not published in any journal. During entire study period. During entire study period. This study is a Phase IV, Single Arm, Multi-Centric, Non-Comparative, Study to Evaluate Efficacy, Safety And Tolerability Of Bicalutamide In Advanced and/or Metastatic Prostate Cancer. The primary objective of the trial is to assess the reduction in circulating Prostate Specific Antigen (PSA) levels in patients of Prostate Cancer undergoing treatment with Bicalutamide. The duration of study is 42 weeks including 16 weeks of enrolment period, 24 weeks treatment period and 2 weeks of post treatment follow-up. Total 36 patients across 5 participating centers in will complete the study. The study will be conducted in 3 phases: Screening Phase (Screening Visit), Enrollment Phase and Treatment Phase (Visit 1-Visit 7) and Follow-up Phase (Visit 8). page 5 / 5