Clinical Trial Details (PDF Generation Date :- Wed, 02 May 2018 19:39:07 GMT) CTRI Number Last Modified On 30/01/2017 Post Graduate Thesis Type of Trial Type of Study Study Design Public Title of Study Scientific Title of Study CTRI/2015/05/005811 [Registered on: 26/05/2015] - Trial Registered Prospectively No Interventional Drug Biological Randomized, Parallel Group Trial A study comparing PF-05280586 to MabThera (rituximab) in patients with follicular lymphoma who have not received previous treatment. A phase 3, randomized, double-blind study of PF-05280586 versus Rituximab for the first-line treatment of patients with CD20-positive, low tumor burden, follicular lymphoma Secondary IDs if Any Secondary ID Identifier Details of Principal Investigator or overall Trial Coordinator (multi-center study) 2014-000132-41 EudraCT B3281006 Protocol Amendment 1 dated 08 May 2014 NCT02213263 USIND- 110,426 Designation Affiliation Protocol Number ClinicalTrials.gov Other Details of Principal Investigator Details Contact Person (Scientific Query) Details Contact Person (Public Query) Phone Fax Email Designation Affiliation Details Contact Person (Scientific Query) Swapnali Raut Director Compliance Oversight Pfizer Limited Phone 09821415224 Fax 022-26788292 Email Designation Affiliation Pfizer Centre, Patel Estate, SV Road, Jogeshwari West Mumbai 400102 India Swapnali.Raut@Pfizer.com Details Contact Person (Public Query) Swapnali Raut Director Compliance Oversight Pfizer Limited Pfizer Centre, Patel Estate, SV Road, Jogeshwari West Mumbai 400102 page 1 / 7
Source of Monetary or Material Support Primary Sponsor Details of Secondary Sponsor Countries of Recruitment Sites of Study India Phone 09821415224 Fax 022-26788292 Email Swapnali.Raut@Pfizer.com Source of Monetary or Material Support > Pfizer Inc, 235 East 42nd Street, New York, NY 10017, United States of America Type of Sponsor NIL List of Countries Austria Belarus Belgium Brazil Canada Croatia Egypt France Germany Greece India Italy Japan Lebanon Mexico Other Peru Philippines Poland Portugal Republic of Korea Romania Russian Federation South Africa Spain Switzerland Thailand Turkey Ukraine United Kingdom United States of America of Principal Investigator Primary Sponsor Details Pfizer Limited The Capital, 1802/1901, Plot No. C-70, G Block, Bandra Kurla Complex, Bandra (East), Mumbai 400051, Maharashtra, India Pharmaceutical industry-indian NIL of Site Site Phone/Fax/Email page 2 / 7
Dr Srinivas Chakravarthy Gummaraju Dr Raja Madras Ananthanarayanan Dr Manikandan Dhanushkodi Dr Biju George Dr Abhishek Satyawan Jadhav Apollo Hospitals (Apollo Cancer Institute) Apollo Speciality Hospital Cancer Institute (W.I.A) Regional Cancer Center Christian Medical College Curie Manavata Cancer Centre Room No: 04, Ground floor, Department of oncology Jubilee Hills, Hyderabad-500096, Telangana Hyderabad ANDHRA PRADESH Room Number 17 & 18, Department of Oncology, Padma Complex, 320, Anna Salai, Chennai 600035 Chennai TAMIL NADU 09989299091 040-23543270 Halarusri@yahoo.com 044-24362424 044-24362424 drmaraja@gmail.com Medical Oncology 09965506957 Clinical Research Unit, 044-22354508 3rd Floor, Bhagwan dmani1982@gmail.com Mahaveer Vishranthi Graha building, Dr. S. Krishnamurthy Campus, N0-38, Sardar Patel Road, Adyar, Chennai-600036 Chennai TAMIL NADU Room # 3, Department of Haematology, IDA Scudder Road Vellore-632004 Vellore TAMIL NADU Curie Manavata Cancer Centre, Department-surgical oncology Ground floor, OPD No-2, Opp. Mahamarg Bus Stand, Mumbai Naka, Nashik- 422004, Nashik Dr Ravikumar Saxena Global Hospital Department of Oncology, Room # 11, Fifth Floor, 6-1-1070/1 to 4, Lakdi-ka-pul, Hyderabad - 500 004 Hyderabad ANDHRA PRADESH Dr Vijay Kumar Mahobia Dr Satheesh C T Government Medical College & Hospital HealthCare Global Enterprises Limited 85, Dept. of Radiation Therapy & Oncology Medical College Road, Near Hanuman Nagar, Nagpur 440003 Nagpur HCG Towers, #8, P.Kalinga Rao Road Sampangi Ram Nagar 0416-2282352 0416-2226449 biju@cmcvellore.ac.in 09075525235 025-32594866 drabhishek@mcrinasik. com 09949385000 040-23244455 ravikumar1960@hotmai l.com 09881287465 0712-2745209 drvijay_mahobia@yaho o.com 09242698750 080-33466059 drsateeshct@gmail.co page 3 / 7
Dr Sameer Ramesh Melinkeri Dr Karthik S Udupa Jehangir Clinical Development Centre Pvt. Ltd. Kasturba Hospital and Medical College Bangalore 560 027 Bangalore KARNATAKA Clinical Research Department, Jehangir Hospital Premises, 32, Sassoon Road, Pune- 411001 Pune Shirdi Saibaba Cancer Hospital & Research Center, Post Box No. 7, Manipal University Manipal-576104 Udupi KARNATAKA Dr Ashish Dixit Manipal Hospital Clinical Research Department, 3rd floor, # 98, HAL Airport Road, Bangalore-560017 Bangalore KARNATAKA Dr Prantar Chakrabarti Dr Sandeep Kumar Jasuja Dr Narendra Agrawal Dr Tanveer Mohibbhai Maksud Dr Shravan Narsingrao Tungenwar N. R. S. Medical College & Hospital, R. K. Birla Cancer Centre, Sawai Man Singh Hospital Rajiv Gandhi Cancer Institute and Research Centre Unique Hospital Multispeciality & Research Institute United CIIGMA Institute of Medical Sciences Pvt. Ltd. Room # 01, Department of Hematology, 138, A.J.C. Bose Road, Kolkata 700014, Kolkata WEST BENGAL Department of Medical Oncology & BMT, Gate No. 06, JLN Marg Jaipur RAJASTHAN m 09371608489 020-26059319 docmelinkeri@yahoo.co m 09845317153 0820-2922928 udupa.k@gmail.com 09845217521 080-25207181 ashish.dixit@manipalho spitals.com 9433018899 033-22266118 prantar@gmail.com 09660121475 sandeepjasuja@gmail.c om Hemato-Oncology Unit, 09868764808 Room No 2261, Second 011-27051670 Floor, New building, narendra_ag1@rediffm Sector-5, Rohini, New ail.com Delhi-110085 New Delhi DELHI Basement, OPD- 02, Clinical Research Department,Opp. Kiran Motor, Nr.Canal, Civil Hospital Char Rasta - Sosyo Circle Lane, Off Ring Road, Surat- 395002 Surat GUJARAT Wing A, Sixth Floor, Research Department, Plot No. 6, 7, Survey No. 10, Shahanoorwadi Darga Road, Aurangabad - 431 005 Aurangabad 09909918887 0261-2636318 tanveermaksud@gmail. com 09763708445 0240-6676690 drshravan.uch@gmail.c om page 4 / 7
Details of Ethics Committee Regulatory Clearance Status from DCGI Health Condition / Problems Studied of Committee Approval Status Date of Approval Is Independent Ethics Committee? Cancer Institute (W.I.A) Committee Apollo Hospitals, Chennai Apollo Hospitals, Hyderabad Jehangir Clinical Development Centre Pvt. Ltd, Pune Kodlikeri Memorial Hospital & CIIGMA Hospital of Manipal Hospitals of SMS Medical College & Attached Hospitals, Unique Hospital Submittted/Under Review No Date Specified No Approved 11/02/2015 No Approved 14/11/2015 No Approved 22/07/2015 No Approved 29/12/2014 No Approved 10/09/2015 No Approved 03/10/2016 No Approved 01/11/2015 No -Silver Approved 02/09/2015 No HCG Central Ethics Committee Committee, Global Hospitals Committee, Government Medical College Committee, N.R.S. Medical College & Hospital, (IECNRSMH) Institutional Review Board, Rajiv Gandhi Cancer Institute And Research Centre Manavata Clinical Research Institute (MCRI EC) Manipal University (MUEC) Status Approved 06/12/2016 No Approved 18/02/2015 No Approved 10/02/2015 No Approved 12/05/2015 No Approved 18/06/2015 No Approved 28/11/2015 No Approved 18/08/2015 No Date Approved/Obtained 16/04/2015 Health Type Patients Condition CD20-positive, low tumor burden, Follicular page 5 / 7
Intervention / Comparator Agent Inclusion Criteria Exclusion Criteria Method of Generating Random Sequence Method of Concealment Blinding/Masking Lymphoma Type Details Intervention Comparator Agent Age From Age To Gender Details Details PF-05280586 (Other : Rituximab-Pfizer) MabThera (Other : Rituximab (EU)) 18.00 Year(s) 99.00 Year(s) Both Computer generated randomization Centralized Inclusion Criteria During the study, patients will receive 4 weekly doses of PF-05280585 or rituximab-eu administered via intravenous infusion using the escalating infusion rate described in the Health Authority approved product labels. Blinded PF-05280586 will be administered at a dose of 375 mg/m2 at Visits 2, 3, 4, and 5 (Days 1, 8, 15, and 22). Blinded investigational product will be administered by IV infusion using the escalating infusion rate described in the Health Authority approved product labels. Blinded rituximab-eu will be administered at a dose of 375 mg/m2 at Visits 2, 3, 4, and 5 (Days 1, 8, 15, and 22). Confirmed diagnosis of low tumor burden, CD20-positive follicular lymphoma (containing no elements of diffuse large B-cell lymphoma) Ann Arbor Stage II, III, or IV Eastern Cooperative Oncology Group (ECOG) status of 0 to 1 At least 1 measureable disease lesion of at least 1.5 cm in longest diameter Exclusion Criteria Not a candidate for treatment with rituximab as a single-agent Evidence of transformation to a high grade or diffuse large B-cell lymphoma Central nervous system or meningeal involvement or cord compression by the lymphoma. T-cell lymphoma. Any prior treatment for lymphoma Any prior treatment with rituximab Active, uncontrolled infection Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded Primary Outcome Outcome Timepoints Objective Response Rate (ORR) according to the revised response criteria for malignant lymphoma (2007) Week 26 Secondary Outcome Outcome Timepoints Time to Treatment Failure (TTF) Week 52 page 6 / 7
Powered by TCPDF (www.tcpdf.org) REF/2015/03/008670 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 Progression-Free Survival(PFS) Week 52 Complete Remission (CR) rate Week 26 Duration of response Week 52 Overall survival Week 52 Maximum observed plasma concentration (Cmax) Week 52 Minimum observed plasma concentration (Cmin) Week 52 CD19-positive B-cell counts Week 52 Incidence of anti-drug antibodies (ADA) and safety associated with immune response Total Sample Size=394 Sample Size from India=35 29/05/2015 25/11/2014 Years=3 Months=1 Days=0 Open to Recruitment Open to Recruitment Week 52 This study will compare the safety and effectiveness of PF-05280586 versus rituximab-eu in patients with CD20-positive, low tumor burden follicular lymphoma. The primary hypothesis to be tested in this study is that the effectiveness of PF-05280586, as measured by the Overall Response Rate, is similar to that of rituximab-eu. page 7 / 7