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1 Clinical Trial Details (PDF Generation Date :- Mon, 31 Dec :20:34 GMT) CTRI Number CTRI/2010/091/ [Registered on: 03/08/2010] - Last Modified On 07/04/2011 Post Graduate Thesis Type of Trial Type of Study Study Design Public Title of Study Scientific Title of Study Other A post marketing surveillance trial to study the safety and efficacy of two drugs, Neupeg and Neulastim in female patients with advanced breast cancer "A Prospective, Comparative, Randomized, Multicenteric, Open label Post Marketing Surveillance study to compare the Safety and efficacy of once-per-cycle Peg Filgrastim (6 mg/0.6 ml) of Intas Biopharmaceuticals Ltd. to NEULASTIM of ROCHE in support of AT chemotherapy in females patients with Advanced (Stage III and IV) breast 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) IBPL_PF_01 NIL Details of Principal Investigator Oncology Services Ltd S G Highway Details Contact Person (Scientific Query) Oncology Services Ltd S G Highway Details Contact Person (Public Query) Oncology Services Ltd S G Highway page 1 / 5

2 Source of Monetary or Material Support Primary Sponsor Details of Secondary Sponsor Countries of Recruitment Sites of Study > Intas Biopharmaceuticals Limited Type of Sponsor NIL List of Countries of Principal Investigator Dr. Tanveer M Maksud Source of Monetary or Material Support Primary Sponsor Details Intas Biopharmaceuticals Limited of Site Site Phone/Fax/ Bharat Cancer Hospital & Research Institute Surat-bardoli Road,Saroli Surat Dr. Smita Gupte Cancer Clinic 208,Shreevardhan Com plex,,ramdaspeth,war dha Road, Nagpur MAHARASHTRA Dr. Ajay Mehta Dr. C. Haritha Central Cancer Research Institute M.S.Patel Cancer Centre tanveermaksud@yahoo.com smita_gupte@rediffmail.com 11,Shankar Nagar,,West High Court Road, ajayonco@hotmail.com Nagpur MAHARASHTRA Shree Krishna Hospital, Gokalnagar Not Applicable N/A Dr. Rajesh Makadia Mangalam Hospital Opp. Prasang Hall,,Near KKV Hall, 150 ft ring road Rajkot Dr. Ashish Kaushal Medisurge Hospital Mithakhali Six Roads,,Ellis Bridge Dr. Babita Hapani Private Clinic 4th 404,405, Hem Arcade, Vivekanand chawk,, Dr. Yagnik Road, Opp. Swami Vivekanand Statue Not Applicable N/A chiramanah@charutarh ealth.org makadiamonali@yahoo.co.in drashish4@yahoo.co.in babitahapani@hotmail. com Dr.Preety Jain Private Clinic 16/2,K.E.H. Compound,,Opp. jainpreety2005@yahoo. Agrawal Dharmshala,M. com Y.H.Road,- page 2 / 5

3 Details of Ethics Committee Regulatory Clearance Status from DCGI Health Condition / Problems Studied Intervention / Comparator Agent Inclusion Criteria Indore MADHYA PRADESH Dr. Pradeep Shah Shreyas Medical Clinic 2,Premal Appartment,N r.gpo,raopura, Vadodara pradeeprshah@msn.co m of Committee Approval Status Date of Approval Is Independent Ethics Committee? HCG Medisurge Ethics Committee Human Research Ethics Committee-Dr. C Haritha Approved 17/08/2010 Yes Approved 02/08/2010 Yes Dr. Ajay Mehta Dr. Babita Hapani Dr. Pradeep Shah Dr. Preety Jain Dr. Rajesh Makadia Dr. Smita Gupte Independent Ethics Committee-ADITYA for Dr. Tanveer Maksud Status Approved/Obtained Health Type Approved No Date Specified Not Available Date No Date Specified Condition Advanced(Stage III & IV) Breast Cancer Type Details Intervention Peg Filgrastim 6mg/0.6ml Comparator Agent Neulastim 6mg/0.6ml Age From Age To Gender Details Inclusion Criteria 1.Female Patients aged 18 years and above suffering from advanced (Stage III and IV) Breast Cancer eligible for receiving AT (Docetaxel- 75 mg/m2, Doxorubicin- 50 mg/m2) chemotherapy. 2.GCSF and Peg- GCSF naive patients 3.ANC > 1,500/uL 4.Hemoglobin > 9 g/dl 5.Platelets > 100,000/ul 6.Patients with serum creatinine 1.5 mg/dl 7.AST/ALT < 1.5 x ULN, alkaline phosphatase 2.5 x ULN, Bilirubin 2 x ULN page 3 / 5

4 Exclusion Criteria Method of Generating Random Sequence Method of Concealment Blinding/Masking Details Permuted block randomization, fixed Centralized Open Label 8.Patients able to understand and voluntarily provide written informed consent before screening, following an explanation of the nature and purpose of this study 9.Patients able to adhere to the study visit schedule and other protocol requirements 10.Completion of previous chemotherapy more than 4 weeks before randomization Exclusion Criteria 1.History of prior malignancy with myeloid characteristics (e.g., myelodysplastic syndromes, acute or chronic myelogenous leukemia?s) or Any premalignant myeloid condition other than breast cancer with the exception of curatively treated basal cell or squamous cell carcinoma of the skin, in situ cervical carcinoma, or other surgically cured malignancy? 2.Documented active infection at the time of enrolment requiring use of systemic anti- infective or use of any anti infective 72 hours before the study drug administration. 3.Documented positive test for human immunodeficiency virus (HIV) infection? known hypersensitivity to E coli derived products [e.g., Filgrastim pegfilgrastim HUMULIN Insulin, L-1Asparaginase, HUMATROPE Growth Hormone, INTRON A ] 4.Subject is currently enrolled in or 4 weeks have not passed since completing other device or drug trial(s) or is receiving other investigational agent(s) other than placebo (confirmation of prior treatment must be documented) 5.Pregnant or breast-feeding (for subjects of child bearing potential) patients or patients not using adequate contraception (for subjects of child bearing potential) 6.Previous participation in this study - Inability or unwillingness to comply with the protocol procedures 7.Had undergone prior radiation therapy within 4 weeks of randomization into this study (with the exception of spot radiation for bone metastases), 8.Prior bone marrow or stem-cell transplantation, or Prior total cumulative lifetime exposure to doxorubicin more than 240 mg/m2 or epirubicin more than 600 mg/m2. 9.Clinically symptomatic brain metastasis Primary Outcome Outcome Timepoints The primary efficacy endpoint will be Duration of severe Neutropenia (defined as ANC < /L) Secondary Outcome Outcome Timepoints Target Sample Size Phase of Trial Phase 4 Date of First Enrollment () Date of First Enrollment (Global) Secondary efficacy endpoints Total Sample Size=100 Sample Size from = No Date Specified 26/07/2010?Depth of ANC count(nadir) in each cycles as compared to baseline?incidence of Febrile Neutropenia? (Defined as a rise in axillary temperature to >38.5 C for a duration of more than 1 hour while having an absolute neutrophil count < /l)?incidence of severe Neutropenia(defined as ANC < /L)?Time to ANC recovery?use of Antibiotics for the treatment of Febrile Neutropenia page 4 / 5

5 Powered by TCPDF ( PDF of Trial Estimated Duration of Trial Recruitment Status of Trial (Global) Recruitment Status of Trial () Publication Details Brief Summary Years=1 Months=3 Days=0 Not Yet Recruiting?A Prospective, Comparative, Randomized, Multicenteric, Open label Post Marketing Surveillance study to compare the Safety and efficacy of once-per-cycle Peg Filgrastim (6 mg/0.6 ml) of Intas Biopharmaceuticals Ltd. to NEULASTIM of ROCHE in support of AT chemotherapy in females patients with Advanced (Stage III and IV) breast cancer? page 5 / 5