PDF of Trial CTRI Website URL -

Transcription

1 Clinical Trial Details (PDF Generation Date :- Sat, 29 Dec :46:17 GMT) CTRI Number CTRI/2009/091/ [Registered on: 12/08/2009] - Last Modified On 19/08/2014 Post Graduate Thesis Type of Trial Type of Study Study Design Public Title of Study Scientific Title of Study No Interventional Drug Other A Study of Galiximab and Rituximab Versus Rituximab and Placebo in patients with Follicular Non-Hodgkins Lymphoma (NHL). 114NH301: A Phase III, Randomized, Double-Blind Study of Galiximab in Combination With Rituximab Compared With Rituximab in Combination With Placebo for the Treatment of Subjects With Relapsed or Refractory, Follicular Non-Hodgkins Lymphoma. Acronym: TARGET 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) 114NH301_14 Dec 2006 NCT Protocol Number ClinicalTrials.gov Details of Principal Investigator Mamta Madaan Clinical Trial Lead Phone Fax Biogen Idec Biotech Pvt. Ltd. Biogen Idec Biotech Pvt. Ltd. Vatika Towers, B Block, 14th Floor mamta.madaan@biogenidec.com Details Contact Person (Scientific Query) Dr Anjali Nagpal Phone Fax Medical Affairs Country Head Biogen Idec Biotech Pvt. Ltd. Biogen Idec Biotech Pvt. Ltd. Vatika Towers, B Block, 14th Floor anjali.nagpal@biogenidec.com Details Contact Person (Public Query) Dr Ritika Bajaj Clinical Reseach Country Head Biogen Idec Biotech Pvt. Ltd. Biogen Idec Biotech Pvt Ltd Sector 54, page 1 / 5

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 > Biogen Idec Research Limited, Innovation House 70 Norden Road Maidenhead, Berkshire SL6 4AY United Kingdom Type of Sponsor Biogen Idec Biotech Pvt Ltd Max Neeman International List of Countries of Principal Investigator Dr Naresh Somani Mr Ranamale VidyadharM Primary Sponsor Details Biogen Idec Ltd UK Biogen Idec Hemophilia Innovation House, 70 Norden Road, Maidenhead, Berkshire, SL6 4AY, UK Other [Biotech Company] 14th Floor, Vatika Towers, Golf Course Road, Sector -54 Haryana Max Neeman International Max House, GF 1, Dr. Jha Marg, Okhla New Delhi of Site Site Phone/Fax/ Bhagwan Mahaveer Jain Cancer Hospital & Research Centre Deenanath Mangeshkar Hospital Oncology,Jawahar lal Nehru Marg Jaipur RAJASTHAN Oncology,Erandawane Pune MAHARASHTRA Dr Rajeev Bedi Fortis Hospital Oncology,Sector 62 Phase Mohali Chandigarh CHANDIGARH Dr Atul Sharma Institute Rotary Cancer Hospital All Institute of Medical Sciences,Dept of Medical Oncology, Ansari Nagar New Delhi DELHI DrRevannath A Narode Kashyap Nursing Home Oncology,Khodadad Circle, Dadar T.T Mumbai MAHARASHTRA DrShanthi Narasimiah DrBetty George K Kidwai Memorial Institute of Oncology Lakeshore Hospital and Research Centre Oncology,Hosur Road Bangalore KARNATAKA Oncology,NH-47 Bypass, Maradu Ernakulam drsomani@somexresea rch.com vid.ranamale101@gmai l.com rajeev.bedi@fortishealt hcare.com atul1@hotmail.com revan_yog@yahoo.com shanthikmio@rediffmail. com bettygeorge_anil@hotm ail.com page 2 / 5

3 Details of Ethics Committee Regulatory Clearance Status from DCGI Health Condition / Problems Studied Intervention / Comparator Agent DrVeenugopal Muraleedharan Dr Anchal Kumar Yadav Regional Cancer Centre KERALA Oncology,Medical College Campus Thiruvananthapuram KERALA Searoc Cancer Hospital Oncology,Sector-5 Sikar Road Jaipur RAJASTHAN drvenurcc@gmail.com anishmaru@yahoo.com of Committee Approval Status Date of Approval Is Independent Ethics Committee? Bhagwan Mahaveer Cancer Hospital and Research Centre, Ethics Committee Ethics Committee, Fortis Hospital Human Ethics Committee, Tata Memorial Hospital Approved 05/05/2009 No Approved 25/05/2009 No Approved 22/05/2009 No ICON Ethics Committee Approved 27/03/2009 Yes Institute Ethics Committee, All Institute of Medical Sciences Institutional Ethics Committee, Deenanath Mangeshkar Hospital Institutional Ethics Committee, Nizams Institute of Medical Sciences Lakeshore Ethics Committee Medical Ethics Committee, Kidwai Memorial Institute of Oncology SEAROC ETHICS COMMITTEE Status Approved 08/04/2009 No Approved 20/04/2009 No Approved 21/05/2009 No Approved 28/04/2009 No Approved 12/06/2009 No Approved 24/03/2009 No Date Approved/Obtained 31/07/2007 Health Type Patients Condition Follicular Non-Hodgkins Lymphoma Type Details Intervention Galiximab 500mg/m2 IV, once weekly for 4 Intervention Rituximab 375mg/m2 IV, once weekly for 4 Comparator Agent Rituximab 375mg/m2 IV, once weekly for 4 Comparator Agent Placebo IV once weekly for 4 page 3 / 5

4 Inclusion Criteria Exclusion Criteria Method of Generating Random Sequence Method of Concealment Blinding/Masking Age From Age To Gender Details Details Computer generated randomization Centralized Inclusion Criteria Key Inclusion Criteria - Aged >= 18 years old at the time of informed consent. - Histologically confirmed follicular Grade 1-3a NHL. - Relapsed or progressive disease after at least 1 prior chemotherapy requiring treatment. - Bidimensionally measurable disease with at least 1 lesion >= 2.0 cm in a single dimension. - Acceptable hematologic, hepatic, and renal function parameters. - Recovered fully from any significant toxicity associated with prior surgery, radiation treatments, chemotherapy, biological therapy, autologous bone marrow or stem cell transplant, or investigational drugs. Exclusion Criteria Key Exclusion Criteria - Follicular lymphoma Grade 3b. - Rituximab refractory or refractory to anti-cd2o radioimmunotherapy (no response to prior rituximab or prior rituximab-containing regimen, or a response with a TTP of less than 6 months). - Cancer radiotherapy, biological therapy, or chemotherapy within 3 prior to Study Day 1 (6 if nitrosourea or mitomycin C). - Prior lymphoma vaccine therapy within 12 months prior to Study Day 1. - Prior antibody therapy for lymphoma (including radioimmunotherapy) within 6 months prior to Study Day 1. - Autologous bone marrow or stem cell transplant within 6 months prior to Study Day 1. - Prior allogeneic transplant. - Transfusion-dependent subjects. - Another primary malignancy requiring active treatment (except hormonal therapy). - Serious nonmalignant disease (e.g., congestive heart failure, hydronephrosis); active uncontrolled bacterial, viral, or fungal infections; or other conditions, which would compromise protocol objectives in the opinion of the Investigator andlor the Sponsor. - New York Heart Association Class 111 or IV cardiac disease or myocardial infarction within 6 months prior to Study Day 1. Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded Primary Outcome Outcome Timepoints Progression free survival (PFS) Approximately 4 years Secondary Outcome Outcome Timepoints Target Sample Size Phase of Trial Phase 3 Secondary efficacy measures include: event-free survival, time to progression, duration of response, complete response rate, and overall survival. Safety measures include: adverse event rates, clinical laboratory results, development of anti-galiximab and human anti-chimeric antibodies. Pharmacokinetics Quality of Life using both the Functional Assessment of Cancer Therapy - (FACT-G) and the EQ-5D (EuroQoL) instruments. Total Sample Size=742 Sample Size from =60 page 4 / 5

5 Powered by TCPDF ( PDF of Trial 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 13/05/ /11/2006 Years=4 Months=0 Days=0 Other (Terminated) Other (Terminated) None This is a Phase 111, multicenter, global, clinical study of an investigational drug called galiximab in combination with an approved drug called rituximab in subjects with follicular NHL. The purpose of the study is to compare the clinical benefit of galiximab when given in combination with rituximab as compared with rituximab alone (given with placebo) in subjects with follicular NHL. Safety and pharmacokinetics (PK) of galiximab and rituximab will also be evaluated. Approximately 60 patients will be enrolled in. The trial opened for screening in on 25th March 2009 and the first patient was enrolled on 13th May Reason of termination of the study: Due to the increasing difficulty in enrolling patients in the trial at global level, Biogen Idec (the Sponsor of this study) believes the current study design will no longer allow completion of the study within an acceptable time frame and has therefore made the decision to prematurely end the study. Standards of care and the number of available treatment options for the study indication have changed considerably since the study opened in 2006 and as a consequence global enrolment to this protocol has been more difficult than originally foreseen. Now, with the recently announced positive efficacy results from the Primary Rituximab and Maintenance (PRIMA) study expected to further reduce the available patient population. This decision is not the result of any safety or efficacy related concerns with Galiximab. The study Independent Data Monitoring Committee (IDMC) met on September 19, 2009 to review the safety and efficacy data for the TARGET study and concluded that there are no safety concerns for current or future patients in the study. T he above information has been communicated to health authorities - FDA on the 23rd Oct 09. page 5 / 5