Clinical Trial Details (PDF Generation Date :- Mon, 03 Sep 2018 18:46:09 GMT) CTRI Number Last Modified On 18/07/2016 Post Graduate Thesis Type of Trial Type of Study Study Design Public Title of Study Scientific Title of Study CTRI/2014/08/004868 [Registered on: 12/08/2014] - Trial Registered Prospectively Interventional Drug Randomized, Parallel Group Trial A clinical trial intended to compare safety and efficacy of two formulations in patients with metastatic Colorectal Cancer (mcrc). Open label randomized bioequivalence study to evaluate the pharmacokinetic (PK) and safety profile of Bevacizumab Biosimilar (BEVZ92) in combination with FOLFOX or FOLFIRI versus Bevacizumab (AVASTIN ) in combination with FOLFOX or FOLFIRI as first-line treatment in patients with metastatic ColoRectal Cancer (mcrc). Secondary IDs if Any Secondary ID Identifier Details of Principal Investigator or overall Trial Coordinator (multi-center study) Details Contact Person (Scientific Query) BEVZ92-A-01-13, Version 1.0 dated 23 Aug 14 Protocol Number Details of Principal Investigator Dr Charu Gautam Associate VP Global Clinical Operation Phone 07966135655 Bungalow Road, Bodakdev cgautam@clianthatrials.com Details Contact Person (Scientific Query) Dr Charu Gautam Associate VP Global Clinical Operation Bungalow Road, Bodakdev Details Contact Person (Public Query) Phone 07966135655 cgautam@clianthatrials.com Details Contact Person (Public Query) Dr Chirag Shah Head- Clinical Trials Bungalow Road, Bodakdev page 1 / 5
Source of Monetary or Material Support Primary Sponsor Details of Secondary Sponsor Countries of Recruitment Sites of Study Phone 07966135631 > Sponsor: MABXIENCE SA Type of Sponsor NIL List of Countries Argentina Brazil Peru Russian Federation Ukraine of Principal Investigator Dr C Haritha cshah@clianthatrials.com Source of Monetary or Material Support Primary Sponsor Details MABXIENCE SA Yaguarón 1407 Oficina 904 C.P. 11100, Montevideo, Uruguay Pharmaceutical industry-global NIL of Site Site Phone/Fax/ Manibhai Shivabhai Cancer Centre, Karamsad Dr Sajid Abdul Rehman Regional Cancer Center, Trivendrum Dr Anita Ramesh Sri RamaChandra Medical Centre, Chennai Clinical Research wing, Ground Floor, Dept. of Medical Oncology, Manibhai Shivabhai Cancer Centre, Shri Krishna Hospital and Medical Centre, Gokal Nagar, Karamsad- 388 325, Gujarat, Department of Medical Oncology, 1st Floor, Regional Cancer Center, Radiation Oncology, Medical College Campus, Trivendrum- 695 011, Kerala, Thiruvananthapuram KERALA Department of Medical Oncology, Sri RamaChandra Medical Centre, 1, Ramachandra Nagar, Porur, Chennai-600 016, Tamilnadu, Chennai TAMIL NADU 02692222415 02692222400 chiragp@charutarhealth.org 04712522497 04712552065 drsajeed.rcc@gmail.co m 04445928828 04445928678 anitachandra100@yaho o.co.in page 2 / 5
Details of Ethics Committee Regulatory Clearance Status from DCGI Health Condition / Problems Studied Intervention / Comparator Agent Inclusion Criteria Dr Vikas Ostwal Tata Hospital, Mumbai Room. 1222, 12th floor, HBB block, Tata Memorial Hospital, Dr. Ernest Borge Road, Parel, Mumbai-400012, Maharashtra, Mumbai MAHARASHTRA 02224177000 02224168604 dr.vikas.ostwal@gmail. com of Committee Approval Status Date of Approval Is Independent Ethics Committee? Human Ethics Submittted/Under Committee, H M Patel Review Centre for Medical Care and Education, Gokal Nagar, Karamsad Human Ethics Committee, Regional Cancer Center, Medical College Campus, Trivendrum Institutional Ethics Committee, Mumbai Institutional Ethics Committee, Sri RamaChandra Medical Centre Status Submittted/Under Review Submittted/Under Review Date Specified Date Specified Date Specified Approved 05/05/2014 Date Approved/Obtained 21/07/2014 Health Type Patients Condition patients with metastatic ColoRectal Cancer (mcrc) Type Details Intervention Bevacizumab Biosimilar Bevacizumab (5 mg/kg) will be administered initially as a 90-minute infusion Comparator Agent AVASTIN (Roche/Genentech Avastin (5 mg/kg) will be administered initially as a 90-minute infusion Age From Age To Gender Details 18.00 Year(s) 65.00 Year(s) Both Inclusion Criteria 1. Patients must have signed an informed consent before any study related procedure or evaluation is performed. 2. Patients must be > 18 years of age. 3. Patient must not have had prior chemotherapy for advanced or metastatic disease. Patients could have received adjuvant chemotherapy or adjuvant chemo-radiotherapy. 4. Patient with mcrc for whom bio-chemotherapy is indicated. 5. Patients must have at least one measurable non-irradiated site of disease according to RECIST criteria. 6. Minimum of 4 weeks since any major surgery, completion of radiation, or completion of all prior systemic anticancer therapy. 7. ECOG performance status? 2. page 3 / 5
Exclusion Criteria Method of Generating Random Sequence Method of Concealment Blinding/Masking Details Computer generated randomization Centralized Open Label Exclusion Criteria 1. Prior treatment for advanced or metastatic colorectal cancer. 2. Prior treatment with an anti-angiogenesis agent, in either the neoadjuvant or adjuvant setting. 3. Concurrent use of investigational anti-neoplastic agents (including up to 4 weeks prior to enrolment). 4. History of any other malignancy unless the malignancy is in complete remission and the patient has been off all therapy for that malignancy for at least 5 years. 5. Chronic treatment with systemic steroids or other immunosuppressive agents; topical or inhaled corticosteroids are allowed. 6. Scheduled immunization with attenuated live vaccines during study period or within 1 week prior to study entry. 7. Uncontrolled brain or lepto-meningeal metastases, including patients who continue to require glucocorticoids for brain or leptomeningeal metastases. 8. Patients with active bleeding or history of bleeding diathesis on oral anti-vitamin K medication (except low dose coumadin) within the past 6 month prior to randomization or coagulopathy. Primary Outcome Outcome Timepoints To compare the PK profile of Bevacizumab and Avastin, both administered in combination with FOLFOX (any) or FOLFIRI. Cycle 1: 0 h(pre-infusion), end of infusion; 1 h, 2 h, 6 h, 24 h (D2), 48h (D3),72h (D4), 120h (D6), 168 h (D8) & 240 h (D11) after end of infusion.cycle 2- Cycle 5: 0 h(pre-infusion), end of infusion on D1 of Cycles 2 and 5 Cycle 7: 0h, end of infusion; 1 h, 2 h, 6 h after end of infusion on D1 and thereafter one sample at 24 h (D2), 48 h (D3), 72 h (D4), 120 h (D6), 168 h (D8), 240 h (D11) after end of infusion (Cycle 7)and 336 h(d15, just before the start of the bevacizumab of Cycle 8 Secondary Outcome Outcome Timepoints Target Sample Size Phase of Trial Phase 3 Date of First Enrollment () Date of First Enrollment (Global) Estimated Duration of Trial Comparation the safety profile of Bevacizumab and Avastin, both administered in combination with FOLFOX (any) or FOLFIRI. Total Sample Size=100 Sample Size from =40 25/08/2014 01/09/2014 Years=1 Months=0 Days=0 At the End of study. i.e. After 12 months. page 4 / 5
Powered by TCPDF (www.tcpdf.org) PDF of Trial Recruitment Status of Trial (Global) Recruitment Status of Trial () Publication Details Brief Summary Completed Completed ne Yet The study is Open label randomized bioequivalence study to evaluate the pharmacokinetic (PK) and safety profile of Bevacizumab. Biosimilar (BEVZ92) in combination with FOLFOX or FOLFIRI versus Bevacizumab (AVASTIN ) in combination with FOLFOX or FOLFIRI as first line treatment in patients with metastatic ColoRectal Cancer (mcrc). This study will be initiated only after obtaining the approvals of Institutional/ Independent Ethics Committee (IEC), clinical trial permission from the Drug Controller General of (DCGI). The subjects qualifying inclusion and exclusion criteria will be invited to participate in this study. The recruitment will happen as per randomization schedule. Randomization list will be generated by computer generated randomization number.the study will be an open label study. All the Response assessment for the enrolled patients will be based on RECIST Criteria Version 1.1. The study will be conducted in 6 patients to determine the infusion toxicities. These patients will be reviewed by the DSMB. If there are no clinically significant or higher incidences of infusion reactions, the participants will continue to receive the therapy and complete the 7 cycles as per the protocol. page 5 / 5