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1 Clinical Trial Details (PDF Generation Date :- Fri, 14 Dec :53:50 GMT) CTRI Number Last Modified On 15/02/2013 Post Graduate Thesis Type of Trial Type of Study Study Design Public Title of Study Scientific Title of Study CTRI/2011/12/ [Registered on: 07/12/2011] - Trial Registered Prospectively Interventional Biological Randomized, Parallel Group, Active Controlled Trial Randomized comparative study of GSK versus Neupogen for the Prophylaxis of Severe Neutropenia in Subjects With Lung Cancer - Advanced Stage III or IV or Recurrent n Small Cell. A Randomized, Double Blind, Multicenter, Phase 3 Study Comparing the Safety and Immunogenicity of GSK With Neupogen for the Prophylaxis of Severe Neutropenia After Myelosuppressive Chemotherapy in Subjects With Advanced Stage III, IV or Recurrent n Small Cell Lung Cancer. Secondary IDs if Any Secondary ID Identifier Details of Principal Investigator or overall Trial Coordinator (multi-center study) GCF Amendment 1 dated 28 March 2011 Protocol Number Designation Affiliation Details of Principal Investigator Details Contact Person (Scientific Query) Details Contact Person (Public Query) Phone Fax Designation Affiliation Details Contact Person (Scientific Query) Dr Neera Gupta MD Phone Fax Designation Affiliation General Manager-Medical Services, Classic Brands CoE-Oncology & Biosimilars GlaxoSmithKline Asia Private Ltd. 252, Dr. Annie Besant Road Worli, Mumbai Mumbai India neera.r.gupta@gsk.com Details Contact Person (Public Query) Arun Sundriyal Associate Director - Clinical Management PPD Pharmaceutical Development India Pvt Ltd. 4th Statesman House, Barakhamba Road, Cannought Place, New Delhi New Delhi DELHI India page 1 / 8

2 Source of Monetary or Material Support Primary Sponsor Details of Secondary Sponsor Countries of Recruitment Sites of Study Phone Fax Source of Monetary or Material Support > GlaxoSmithKline Research and Development Limited, 980 Great West Road Brentford, Middlesex, TW8 9GS United Kingdom Type of Sponsor Primary Sponsor Details GlaxoSmithKline Research and Development Limited 980 Great West Road Brentford, Middlesex, TW8 9GS United Kingdom Pharmaceutical industry-global PPD Pharmaceutical Development India Pvt Ltd List of Countries India Thailand of Principal Investigator Dr Chirag Shah Dr Ajay Mehta Dr Rajnish Nagarkar Dr Chetan Deshmukh Dr Venkatesan Srinivasan 01-Dynasty B-Wing (Kanakia Spaces),Andheri-Kurla Rd, Andheri East Mumbai , India of Site Site Phone/Fax/ Apollo Hospitals International Limited Central India Cancer Research Institute Curie Manavata Cancer Centre Deenanath Mangeshkar Hospital and Research Centre Dr. Kamakshi Memorial Hospital Dr Sanjiv Kumar Verma Himalayan Institute Hospital Oncology and Haematology, Plot.1 A, BHAT GIDC Estate, Gandhinagar, Gandhinagar GUJARAT Oncology, 11, Shankar Nagar, Nagpur, Nagpur Opposite Mahamarg Bus Stand, Mumbai Naka, Nasik, Nashik Medical Oncology, Eradwane, Pune, Pune Oncology,.1, Radial Road, Pallikkaranai, Chennai, Chennai TAMIL NADU drchiragashah@gmail.c om ajayonco@hotmail.com drraj@manavatacancer centre.com drchetandeshmukh@g mail.com vsrinivasan09@gmail.c om Surgery, Sushila Tiwari Memorial Cancer Research skverma177@gmail.co Institute, Swami Ram m Nagar, Dehradun, page 2 / 8

3 Details of Ethics Committee Dr Rakesh Chopra Dr Sachin Hingmire Dr K C Lakshmaiah Dr Anjna Surath Dr Asish Mukhopadhyay Dr Shailesh Bondarde Indraprastha Apollo Hospitals Jehangir, Clinical Development Centre Pvt. Ltd. Kidwai Memorial Institute of Oncology Krishna Institute of Medical Sciences Netaji Subhash Chandra Bose Cancer Hospital Research Institute Dehradun UTTARANCHAL Oncology, Sarita Vihar, Delhi-Mathura Road, New Delhi New Delhi DELHI 32 Sassoon Road, Pune, Pune Medical Oncology, Dr M.H. Marigowda Road,Hosur, Bangalore Bangalore KARNATAKA Minister Road, Secunderabad, Hyderabad ANDHRA PRADESH N.C.R.I. (R & D Division) 16 A Park Lane, Park Street, Kolkata, Kolkata WEST BENGAL Shatabdi Superspeciality Hospital Oncology, Suyojit City Centre, Opp. Mahamarg Bus Stand, Nasik, Nashik Dr Anish Maru SK Soni Hospital Medical Oncology, Sector 5, Sikar Road, Vidhyadhar Nagar, Jaipur, Jaipur RAJASTHAN Dr Vanita ronha TATA Memorial Hospital Medical Oncology, Dr. E, Borges road, Parel, Mumbai Mumbai rakeshchopramd@hotm ail.com sshingmire@yahoo.co m kcluck@gmail.com anjnasurath@hotmail.c om ncri.clinicaltrials@gmail. com shaileshbondarde@yah oo.com anishmaru@yahoo.com vanita.noronha@gmail. com of Committee Approval Status Date of Approval Is Independent Ethics Committee? Central India Cancer Research Institute Ethics Committee (PI - Dr Ajay Mehta) Ethics Committee on Clinical Trials, Indraprastha Apollo Hospital (PI - Dr. Approved 02/06/2011 Approved 10/09/2011 page 3 / 8

4 Rakesh Chopra) Ethics Committee, Apollo Hospitals International Ltd. (PI - Dr Chirag Shah) Human Ethics Committee, Tata Memorial Hospital (PI - Dr Vanita ronha) Committee - Himalayan Institute Hospital Trust University (PI - Dr. Sanjiv Kumar Verma) Committee, Deenanath Mangeshkar Hospital & Research Centre (PI - Dr Chetan Deshmukh) Committee, Hirabai Cowasji Medical Research Institute & Jehangir Clinical Development Centre (PI - Dr Sachin Hingmire) Committee, Kidwai Memorial Institute of Oncology (PI - Dr K C Lakshmaiah) Committee, Krishna Institute of Medical Sciences (PI - Anjna Surath) Manavata Clinical Research Institute, Professional Ethics Committee (PI - Dr Rajanish Nagarkar) Medical Ethics Committee, Dr. Kamakshi Memorial Hospital Pvt. Ltd. (PI - Dr Venkatesan Srinivasan) SEAROC Ethics Committee (PI - Dr Anish Maru) The Ethics Committee, Netaji Subhash Chandra Bose Cancer Research Institute (PI - Dr Asish Mukhopadhyay) Approved 10/08/2011 Date Specified Date Specified Date Specified Approved 03/06/2011 Date Specified Approved 10/08/2011 Approved 10/09/2011 Approved 16/06/2011 Date Specified Approved 06/06/2011 The Approved 16/07/2011 page 4 / 8

5 Regulatory Clearance Status from DCGI Health Condition / Problems Studied Intervention / Comparator Agent Inclusion Criteria Committee, Shatabdi Superspecialty Hospital (PI - Dr Shailesh Bondarde) Status Date Approved/Obtained 05/12/2011 Health Type Patients Condition Advanced Stage III/IV or Recurrent n Small Cell Lung Cancer Type Details Intervention GSK mcg/kg/day administered via SC injection or IV infusion (based on standard of care at each study center). Begin on the third day after the administration of cytotoxic chemotherapy in each cycle. (6 cycles) Comparator Agent Neupogen 5 mcg/kg/day administered via SC injection or IV infusion (based on standard of care at each study center). Begin on the third day after the administration of cytotoxic chemotherapy in each cycle. (6 cycles) Age From Age To Gender Details Year(s) Year(s) Both Inclusion Criteria 1. Subject provides written informed consent. 2. Subject is male or female at least 18 years of age (unless local regulations require an older age). 3. Subject has histologically-confirmed (cytological specimens obtained by bronchial washing, bronchial brushing, or fine-needle aspiration are acceptable), unresectable, stage IIIB NSCLC, with pericardial or pleural effusion; stage IV NSCLC; or recurrent NSCLC. Evaluation of effusions (ie, with cytology) is not required if a diagnosis of NSCLC has been otherwise histologically confirmed. Subjects with cytologically-confirmed disease may be allowed after consultation with the medical monitor. 4. Subject is chemotherapy naive or has not received more than 1 prior regimen of chemotherapy. 5. Subject requires treatment with paclitaxel plus carboplatin every 3 weeks for 6 cycles. 6. Subject has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or Subject has a life expectancy of more than 5 months. 8. Female subjects of childbearing potential must have a negative page 5 / 8

6 Exclusion Criteria Details serum pregnancy test at Screening. 9. Female subjects of childbearing potential (ie, not surgically sterile and/or not postmenopausal for at least 12 months) must be practicing adequate contraception throughout their participation in the study, including the screening and follow up periods. Methods of adequate contraception include abstinence, nonsystemic hormonal barrier, and double-barrier method (eg, condom or occlusive cap plus nonosynol-9). 10. Subjects must have adequate organ function, as defined by the following baseline values: a. Hematological function i. ANC greater or equal to 1.5 x 109/L ii. Platelets greater or equal to 75 x 109/L iii. Hemoglobin greater or equal to 9 g/dl b. Renal function i. Creatinine clearance greater or equal to 40 ml/min (calculated by modified Cockcroft-Gault formula [Rostoker et al 2007]) ii. Serum creatinine less than or equal 1.5 x upper limit of normal (ULN) c. Hepatic function i. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) less than or equal 2.5 x ULN (or less than or equal to 5 x ULN if liver metastases are present) ii. Alkaline phosphatase less than or equal to 2.0 x ULN (or less than or equal to 5.0 x ULN if liver or bone metastases are present) iii. Serum bilirubin less than or equal 1.5 x ULN 11. Subjects with a history of brain metastases are eligible if definitive surgery and/or radiation therapy has been administered, no further treatment is planned, and the subject is clinically stable for at least 2 weeks before randomization Exclusion Criteria 1. Subject received chemotherapy, lithium, or any other medication known to significantly affect ANC within 4 weeks before randomization. 2. Subject has peripheral neuropathy of grade 2 or greater. 3. In the opinion of the investigator, subject has clinically significant third-space fluid collection (eg, ascites or pleural effusions) that cannot be controlled by drainage or other procedures before study enrollment. 4. Subject has evidence of a significant medical condition or laboratory finding that, in the opinion of the investigator, would make it undesirable for the subject to participate in the study. Examples include, but are not limited to, the following: a. Congestive heart failure, as assessed by the investigator based on the practice standards at each study center b. Myocardial infarction within 6 months before randomization c. Significant neurological or psychiatric page 6 / 8

7 Method of Generating Random Sequence Method of Concealment Blinding/Masking Computer generated randomization Centralized Participant and Investigator Blinded disorder that would impact study participation, including but not limited to seizures from brain metastases, clinically significant peripheral vascular disease, abdominal fistula, gastrointestinal perforation, intraabdominal abscess, and coagulopathy d. Superior vena cava syndrome, unless controlled with radiotherapy e. Uncontrolled type 1 or type 2 diabetes mellitus f. Sickle cell disease g. Any contraindication to high dose corticosteroid therapy, such as herpes simplex, herpes zoster, hepatitis, or other disease h. Subjects requiring immunosuppressive agents 5. Subject has a known hypersensitivity to paclitaxel, carboplatin, GCSF, or any of their excipients, including fructose. 6. Subject has a known hypersensitivity to E. coli derived proteins. 7. Subject has an active infection that requires systemic treatment or any uncontrolled infection less than or equal to 14 days before randomization. 8. Subject has had a bone marrow transplant. 9. Subject has received prior treatment with an investigational or marketed rhgcsf (eg, PEG-GCSF) within 4 weeks before randomization. 10. Subject has had major surgery requiring general anesthesia and a significant incision (eg, larger than what is required for central venous catheter placement, percutaneous feeding tube, or biopsy) 28 days before randomization or minor surgery (excluding central venous catheter placement, percutaneous feeding tube, or biopsy) 14 days before randomization. Subjects must have recovered from any surgery-related toxicity. 11. Subject is a female who is pregnant or lactating. 12. Subject has a psychological, familial, sociological, or geographical condition that does not permit compliance with the protocol. 13. Subject is unwilling or unable to follow the procedures required by the protocol. Primary Outcome Outcome Timepoints 1. medullary bone pain 2. laboratory abnormalities of alkaline phosphatase, uric acid, and lactate dehydrogenase 3. severe neutropenia Cycle 1 and Cycle 2 page 7 / 8

8 Powered by TCPDF ( PDF of Trial 4. febrile neutropenia 5. infection 6. immunogenicity Secondary Outcome Outcome Timepoints 1. Absolute neutrophil count 2. medullary bone pain 3. laboratory abnormalities of alkaline phosphatase, uric acid, and lactate dehydrogenase 4. severe neutropenia 5. febrile neutropenia 6. infection Cycle 1 to cycle 6 Target Sample Size Phase of Trial Phase 3 Date of First Enrollment (India) Date of First Enrollment (Global) Estimated Duration of Trial Recruitment Status of Trial (Global) Recruitment Status of Trial (India) Publication Details Brief Summary Total Sample Size=200 Sample Size from India=150 02/01/ /01/2012 Years=2 Months=4 Days=0 Other (Terminated) Other (Terminated) t Applicable. The purpose of this study is to demonstrate that GSK is similar to Neupogen for the prophylaxis of severe neutropenia after myelosuppressive chemotherapy in subjects with advanced stage III/IV or recurrent NSCLC. Additionally, safety and immunogenicity of both products will be assessed and analyzed. page 8 / 8