Clinical Trial Details (PDF Generation Date :- Tue, 11 Dec 2018 13:01:44 GMT) CTRI Number Last Modified On 09/05/2018 Post Graduate Thesis Type of Trial Type of Study Study Design Public Title of Study Scientific Title of Study CTRI/2012/03/002529 [Registered on: 28/03/2012] - Trial Registered Prospectively No Interventional Biological Randomized, Parallel Group, Active Controlled Trial Comparison of study drug Panitumumab With Supportive Care to Best Supportive Care in Patients With Metastatic Colorectal Cancer A Phase 3, Multicenter, Randomized, Open-label Trial to Evaluate the Survival Benefit of Panitumumab and Best Supportive Care, Compared to Best Supportive Care Alone, in Subjects With Chemorefractory Wild-type KRAS Metastatic Colorectal Cancer Secondary IDs if Any Secondary ID Identifier Details of Principal Investigator or overall Trial Coordinator (multi-center study) 20100007, amendment 2 dated 25 July 2013 Protocol Number NCT01412957 Designation Affiliation ClinicalTrials.gov Details of Principal Investigator Details Contact Person (Scientific Query) Details Contact Person (Public Query) Phone Fax Email Designation Affiliation Details Contact Person (Scientific Query) Ashish Virkar Clinical Operation Manager Amgen Technology Pvt. Ltd Phone 022-67869303 Fax 91-22-67869138 Email Designation Affiliation A Wing, Level 4, Dynasty Business Park, A.K Road, Andheri (East) India PIN : 400 059 400059 India avirkar@amgen.com Details Contact Person (Public Query) Dr Veena Jaguste Dir Development Operations Amgen Technology Pvt. Ltd A Wing, Level 4, Dynasty Business Park, A.K Road, Andheri (East) India PIN : 400 059 400059 India page 1 / 6
Source of Monetary or Material Support Primary Sponsor Details of Secondary Sponsor Countries of Recruitment Sites of Study Phone 91-22-67869353 Fax 91-22-67869138 Email > Amgen Inc Type of Sponsor NIL List of Countries Canada China Croatia Estonia India Latvia Lithuania Malaysia Mexico Peru Philippines Republic of Korea Romania Serbia of Principal Investigator Dr Rajnish Nagarkar Dr Srinivasan Krishnan Dr Sadanand Karandikar Dr V P Ganagadharan vjaguste@amgen.com Source of Monetary or Material Support Primary Sponsor Details Amgen Technology Pvt Ltd A Wing, Level 4, Dynasty Business Park, A.K Road, Andheri (East) India PIN : 400 059 Other [Biotech Company - Global] NIL of Site Site Phone/Fax/Email Curie Manavata Cancer Centre, Nashik Dr. Rai Memorial Medical Centre, Chennai Grant Medical Foundation, Ruby Hall Clinic LakeShore Hospital & Research Centre Ltd, Curie Manavata Cancer Centre, Opp. Mahamarg Bus Stand, Nashik-422004 Maharashtra Nashik 91-9823061929 91-253-2594866 drrajnagarkar@yahoo.c o.in Dr. Rai Memorial 9952933735 Medical Centre No. 44-42132054 562, Century Plaza, Krishnan_dr@yahoo.co Anna Salai, Teynampet, m Chennai- 600 018, Tamil Nadu, India Chennai TAMIL NADU 40, Sassoon Road, Pune, Maharashtra- 411001 Pune LakeShore Hospital & Research Centre Ltd, 020-26123391 020-66455603 skaran44@gmail.com 0484-2701032 0484-2703573 page 2 / 6
Details of Ethics Committee Regulatory Clearance Status from DCGI Dr Nalini Kilara Dr Shailesh Bondarde Dr Prachi Patil Cochin M S Ramaiah Curie centre of Oncology, Bangalore Shatabdi Superspeciality Hospital, Nashik Tata Memorial Hospital,. Department of Medical Oncology, NH-47 By Pass, Maradu Nettore, P.O Cochin-682304 Kollam KERALA M S Ramaiah Curie centre of Oncology, MS Ramaiah Memorial Hospital, New Bel Road, Bangalore- 560 054, Karnataka Bangalore KARNATAKA Shatabdi Superspeciality Hospital, Suyojit City Center, Near Nashik Naka, Nashik-560020 Maharashtra Tata Memorial Hospital Room No. 13, Dr. E. Borges Road, 400012 drvpg2003@gmail.com 91-80-40528403 91-80-4058402 drnalini.msr@gmail.co m 0253-2501888 91-253-2502105 shaileshbondarde@yah oo.com 9821099898 022-24121464 prachipatil@gmail.com of Committee Approval Status Date of Approval Is Independent Ethics Committee? Ethical Review Board,M.S.Ramaiah Medical and Teaching Hospital,Banglore Institutional Ethics Committee,Dr. Rai Memorial Medical Centre,Chennai. Lakeshore Ethics Committee, Lakeshore Hospital & Research Centre Ltd. Kochi Manavata Clinical Research Institute Professional Ethics Committee, Nashik Shatabdi Hospital Ethics Committee, Nashik The TMC Human Ethics Committee, Tata Memorial Hospital, Status Approved 04/08/2011 No Approved 06/07/2011 No Approved 07/07/2011 No Approved 07/11/2011 No Approved 27/07/2011 No Approved 14/10/2013 No Date Approved/Obtained 31/01/2012 Health Condition / Health Type Condition page 3 / 6
Problems Studied Patients Metastatic Colorectal Cancer Intervention / Comparator Agent Inclusion Criteria Type Details Intervention Experimental: Pmab + BSC ( Best Supportive care ) Comparator Agent Age From Age To Gender Details BSC Alone Best Supportive Care 18.00 Year(s) 80.00 Year(s) Both Inclusion Criteria Panitumumab (administered intravenously 6 mg/kg every 14 days) plus BSC ( Best Supportive care )- every 14 days. Best supportive care treatment as determined by the investigator. Inclusion Criteria: Diagnosis of metastatic colorectal cancer Wild type (without mutation in codons 12 and 13) KRAS gene in tumor tissue confirmed by a central laboratory ECOG performance status of 0, 1 or 2 At least 1 measurable or non measurable lesion per RECIST version 1.1 guidelines. Treatment failure (defined as failure due to either disease progression [clinical or radiological] or toxicity [treatment intolerance]) of a prior regimen containing irinotecan for metastatic disease and a prior regimen containing oxaliplatin for metastatic disease. Oxaliplatin and irinotecan may have been administered sequentially or in combination. Disease relapse within 6 months after completing adjuvant chemotherapy (with either an irinotecan or oxaliplatin containing regimen) will also be considered as treatment failure of a prior regimen for metastatic disease Must have previously received a thymidylate synthase inhibitor (eg, fluorouracil, capecitabine, raltitrexed, or fluorouracil uracil) at any point for treatment of CRC Man or woman at least 18 years of age Adequate hematologic, renal, hepatic and metabolic function Negative pregnancy test within 72 hours before randomization (for women of childbearing potential only) Subject or subjects legally acceptable representative has provided informed consent. Other protocol specified criteria may apply Exclusion Criteria Details Exclusion Criteria: Exclusion Criteria Symptomatic brain metastases requiring treatment History of another primary cancer within 5 years of randomization Prior anti-egfr antibody therapy (eg, panitumumab or cetuximab) or treatment with small molecule EGFR inhibitors (eg, gefitinib, erlotinib, lapatinib) Antitumor therapy (eg, chemotherapy, hormonal therapy, immunotherapy, antibody therapy) within 21 days before randomization Radiotherapy within 14 days before randomization. Exclusion Criteria for QTc Evaluation Subpart of the Study: Prolongation of QT/QTc interval 450 milliseconds at screening Other protocol-specified criteria may apply page 4 / 6
Method of Generating Random Sequence Method of Concealment Blinding/Masking Computer generated randomization Centralized Open Label Primary Outcome Outcome Timepoints Overall Survival (OS): To evaluate the effect of panitumumab and best supportive care (BSC) versus BSC alone on overall survival (OS) in subjects with chemorefractory wild-type codons 12 and 13 Kirsten rat sarcoma viral oncogene homolog (KRAS wt) mcrc. [ Time Frame: Baseline to 8 months average ] [ Designated Secondary Outcome Outcome Timepoints Progression Free Survival (PFS): To evaluate the effect of panitumumab and best supportive care (BSC) versus BSC alone in subjects with wild type RAS (without mutation in KRAS codon 12, 13, 61, 117, 146 or NRAS) Objective Response Rate (ORR): The comparative incidence of either complete response (CR) or partial response (PR) per RECIST version 1.1 between panitumumab and best supportive care (BSC) versus BSC alone in KRAS wt patients Progression Free Survival (PFS): To evaluate the effect of panitumumab and best supportive care (BSC) versus BSC alone in subjects with chemorefractory wild-type codons 12 and 13 Kirsten rat sarcoma viral oncogene homolog (KRAS) mcrc. Objective Response Rate (ORR): The comparative incidence of either complete response (CR) or partial response (PR) per RECIST version 1.1 between panitumumab and best supportive care (BSC) versus BSC alone in RAS wt patients without mutation codons 12, 13, 59, 61, 117 and 146. Safety: Incidence of AEs, significant laboratory changes, and immunogenicity as safety issue: Yes ] QTc Interval length amongst subjects treated with panitumumab as an indicator of effect on cardiac repolarisation [ Time Frame: week 7 ] [ Designated as safety issue: Yes ] Target Sample Size Phase of Trial Phase 3 Date of First Enrollment (India) Overall Survival (OS): To evaluate the effect of panitumumab and best supportive care (BSC) versus BSC alone in subjects with wild type RAS (without mutation in KRAS codon 12, 13, 59, 61, 117, and 163 or NRAS) Total Sample Size=350 Sample Size from India=55 11/03/2012 Date of First 08/11/2011 [ Time Frame: 8 months average ] [ Designated page 5 / 6
Powered by TCPDF (www.tcpdf.org) PDF of Trial Enrollment (Global) Estimated Duration of Trial Recruitment Status of Trial (Global) Recruitment Status of Trial (India) Years=4 Months=8 Days=0 Completed Completed Publication Details Kim TW, Elme A, Kusic Z, Park JO, Udrea AA, Kim SY, Ahn JB, Valencia RV, Krishnan S, Bilic A, Manojlovic N, Dong J, Guan X, Lofton-Day C, Jung AS, Vrdoljak E. A phase 3 trial evaluating panitumumab plus best supportive care vs best supportive care in chemorefractory wild-type KRAS or RAS metastatic colorectal cancer. Br J Cancer. 2016 Nov 8;115(10):1206-1214. doi: 10.1038/bjc.2016.309. Epub 2016 Oct 13. Brief Summary The purpose of this study is to evaluate the benefit of panitumumab in addition to best supportive care compared to best supportive care alone in subjects with chemorefractory wild-type KRAS metastatic colorectal cancer. At the end of study only 23 enrolled in India. Summary of results: A total of 377 participants were randomized at 66 centers in Europe, Asia, North and South America from 8 November 2011 until 30 July 2013. Results are reported as of the primary analysis data cut-off date of 10 June 2014. Reporting Groups: 1. Panitumumab + BSC: Participants received panitumumab administered intravenously 6 mg/kg every 14 days plus best supportive care (BSC) until disease progression, withdrawal of consent, death, or intolerance of study drug. 2. BSC Alone: Participants received best supportive care until disease progression, withdrawal of consent, or death. Results were statistically significant, favoring the panitumumab plus BSC arm compared to the BSC alone arm page 6 / 6