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1 Clinical Trial Details (PDF Generation Date :- Sun, 16 Sep :58:45 GMT) CTRI Number Last Modified On 05/01/2012 Post Graduate Thesis Type of Trial Type of Study Study Design Public Title of Study Scientific Title of Study CTRI/2011/07/ [Registered on: 19/07/2011] - Trial Registered Prospectively No Interventional Biological Randomized, Parallel Group, Placebo Controlled Trial A Study in Second Line Metastatic Colorectal Cancer A Randomized, Double-blind, Multicenter Phase 3 Study of Irinotecan, Folinic Acid, and 5-Fluorouracil (FOLFIRI) Plus Ramucirumab or Placebo in Patients With Metastatic Colorectal Carcinoma Progressive During or Following First-Line Combination Therapy With Bevacizumab, Oxaliplatin, and a Fluoropyrimidine 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) I4T-MC-JVBB NCT Designation Affiliation Protocol Number ClinicalTrials.gov Details of Principal Investigator Anurita Majumdar Medical Director Phone Fax Designation Affiliation Plot #92, Sector 32,Institutional Area Gurgaon HARYANA majumdaran@lilly.com Details Contact Person (Scientific Query) Anil Seth Director Phone Fax Designation Affiliation Plot #92, Sector 32,Institutional Area Gurgaon HARYANA sethan@lilly.com Details Contact Person (Public Query) Anil Seth Director Phone Plot #92, Sector 32,Institutional Area Gurgaon HARYANA page 1 / 6

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 Primary Sponsor Details Corporate Center napolis, IN Type of Sponsor NIL List of Countries Argentina Australia Austria Belgium Brazil Czech Republic Democratic People's Republic of Korea Finland France Germany Israel Italy Japan Netherlands Portugal Romania Slovenia Spain Sweden Taiwan United States of America of Principal Investigator Chanchal Goswami Shekar Patil Govind Babu Pharmaceutical industry-global NIL of Site Site Phone/Fax/ B P Poddar Hospital and Medical Research Ltd HealthCare Global Enterprises, Bangalore, Institute of Oncology Kidwai Memorial Institute of Oncology 1/1 Humayun Kabir Sarani New Alipore Block G Kolkata WEST BENGAL No.8, HCG Towers, P. Kalinga Rao Road, Sampangiram Nagar Bangalore KARNATAKA Hosur Road Bangalore KARNATAKA chanchalg@sify.com sp_associates6@rediff mail.com kgbtrials@yahoo.co.in Vadavattah Lakeshore Hospital and Annex 47, Bypass page 2 / 6

3 Details of Ethics Committee Regulatory Clearance Status from DCGI Health Condition / Problems Studied Intervention / Comparator Agent Gangadharan Research Center Marad, Nettor Kolkata WEST BENGAL Sajeed Rahuman Anish Maru Shyam Aggarwal Regional Cancer SEAROC Cancer Sir Ganga Ram Hospital Medical College Campus, P.O. Box 2417 Thiruvananthapuram KERALA S.K. Soni Hospital, Sector - 5 Sikar Road, Vidhyadhar Nagar Jaipur RAJASTHAN Old Rajinder Nagar New Delhi DELHI Shaesta Mehta Tata Memorial Hospital Dr. Ernest Borges Road, Parel Mumbai MAHARASHTRA drvpg2003@gmail.com salini.rccresearch@gm ail.com anishmaru@yahoo.com drshyam_aggarwal@ya hoo.com shaestamehta@yahoo. com of Committee Approval Status Date of Approval Is Independent Ethics Committee? B P Poddar Hospital EC Approved 18/03/2011 No EC, Regional Cancer EC, SEAROC Cancer EC, Sir Ganga Ram Hospital EC, Tata Memorial Hospital HealthCare Global Enterprises Ethics Committee Lakeshore Hospital and Research Center Status Approved 19/08/2011 No Approved 01/06/2011 No Approved 18/10/2011 No Approved 11/11/2011 No Approved 22/12/2011 No Approved 15/03/2011 No Date Approved/Obtained 26/05/2011 Health Type Patients Condition Colorectal Cancer Type Details Intervention ramucirumab 8mg/kg administered intravenously every 2 weeks until disease progression, unacceptable toxicity, noncompliance or withdrawal of consent by the patient or investigator decision Intervention irinotecan 180mg/m2 administered intravenously every 2 weeks until disease progression, unacceptable toxicity, noncompliance or withdrawal of consent by the patient or page 3 / 6

4 Inclusion Criteria investigator decision Intervention folinic Acid 400mg/m2 administered intravenously every 2 weeks until disease progression, unacceptable toxicity, noncompliance or withdrawal of consent by the patient or investigator decision Intervention 5-fluorouracil 400mg/m2 bolus immediately followed by 2400mg/m2 continuous infusion every 2 weeks until disease progression, unacceptable toxicity, noncompliance or withdrawal of consent by the patient or investigator decision Comparator Agent placebo Administered intravenously every 2 weeks until disease progression, unacceptable toxicity, noncompliance or withdrawal of consent by the patient or investigator decision Age From Age To Gender Details Year(s) Year(s) Both Inclusion Criteria -Histologically or cytologically confirmed metastatic colorectal cancer (patients are eligible to enroll irrespective of KRAS mutation status) -Confirmed metastatic colorectal cancer -The patient has received first-line combination therapy of bevacizumab, oxaliplatin, and a fluoropyrimidine for metastatic disease and a)experienced radiographic disease progression during first-line therapy, or b)experienced radiographic disease progression within 6 months after the last dose of first-line therapy, or c)discontinued part or all of first-line therapy due to toxicity and experienced radiographic disease progression within 6 months after the last dose of first-line therapy; Note that a patient must have received a minimum of 2 doses of bevacizumab as part of a first-line regimen containing chemotherapy -Receipt of no more than 2 prior systemic chemotherapy regimens in any setting (only 1 prior regimen for metastatic disease is permitted); For patients with rectal cancer, sequential neoadjuvant and adjuvant therapy will count as a single systemic regimen -Measurable or nonmeasurable disease based on the Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v. 1.1) -Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 -Adequate hematologic, renal, hepatic and coagulation function -Consent to provide a historical colorectal cancer tissue sample for assessment of biomarkers -Ability to provide signed informed consent -Maximum age in is 75 years Exclusion Criteria Details Exclusion Criteria -Receipt of bevacizumab within 28 days prior to randomization -Receipt of any investigational therapy within 28 days prior to randomization -Receipt of any previous systemic therapy, other than a combination page 4 / 6

5 of bevacizumab, oxaliplatin, and a fluoropyrimidine, for first-line treatment of metastatic colorectal cancer -Known leptomeningeal disease or brain metastases or uncontrolled spinal cord compression -Experience of any arterial thrombotic or arterial thromboembolic events, including, but not limited to myocardial infarction, transient ischemic attack, or cerebrovascular accident, within 12 months prior to randomization -Pregnant (confirmed by serum beta human chorionic gonadotropin [HCG] test within 7 days prior to randomization) or lactating -History of inflammatory bowel disease or Crohns disease requiring medical intervention (immunomodulatory or immunosuppressive medications or surgery) in the 12 months prior to randomization -Acute or subacute bowel obstruction or history of chronic diarrhea which is considered clinically significant in the opinion of the investigator -Grade 3 or higher bleeding event within 3 months prior to randomization -Experience of any of the following during first-line therapy with a bevacizumab-containing regimen: an arterial thrombotic/thromboembolic event, Grade 4 hypertension, Grade 4 proteinuria, a Grade 3-4 bleeding event, or bowel perforation -Known history or clinical evidence of Gilberts Syndrome, or is known to have certain genotypes -Known allergy to any of the study treatment components, including any components used in the preparation of ramucirumab, or other contraindication to receive the study treatments Method of Generating Random Sequence Method of Concealment Blinding/Masking Participant, Investigator and Outcome Assessor Blinded Primary Outcome Outcome Timepoints Overall Survival Baseline to date of death from any cause Secondary Outcome Outcome Timepoints Target Sample Size Phase of Trial Phase 3 Date of First Enrollment () Date of First Enrollment (Global) Estimated Duration of Progression-free survival time Proportion of patients achieving an objective response (objective response rate) Change in European Organisation for Research and Treatment of Cancer [EORTC] QLQ-C30 Incidence of anti-ramucirumab antibodies Cmax and Cmin of ramucirumab Baseline to measured progressive disease or date of death from any cause Baseline, every 6 weeks through week 36, then every 12 weeks thereafter until disease progression Every 2 cycles through cycle 14, then every 4 cycles Baseline, 30-day follow-up Baseline, pre- and post-infusions at cycles 3 and 5, and at 30-day follow-up Change in EuroQol EQ-5D Every 2 cycles through cycle 14, then every 4 cycles Total Sample Size=1050 Sample Size from =25 25/07/ /12/2010 Years=3 page 5 / 6

6 Powered by TCPDF ( PDF of Trial Trial Recruitment Status of Trial (Global) Recruitment Status of Trial () Publication Details Brief Summary Months=0 Days=0 Open to Recruitment Open to Recruitment The purpose of this study is to compare overall survival in patients with metastatic colorectal cancer treated with either ramucirumab and FOLFIRI or placebo and FOLFIRI. page 6 / 6