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CTRI Number  CTRI/2014/08/004868 [Registered on: 12/08/2014] Trial Registered Prospectively
Last Modified On: 18/07/2016
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A clinical trial intended to compare safety and efficacy of two formulations in patients with metastatic Colorectal Cancer (mCRC). 
Scientific Title of Study   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). 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
BEVZ92-A-01-13, Version 1.0 dated 23 Aug 14  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Charu Gautam 
Designation  Associate VP – Global Clinical Operation 
Affiliation  Cliantha Research Limited 
Address  Sigma-1 Corporate, Off S.G.Highway, Bodakdev, Ahmedabad, Gujarat. Cliantha House, Opp. Pushparaj Tower,Near Judges Bungalow Road, Bodakdev Ahmadabad GUJARAT 380054 India

Ahmadabad
GUJARAT
380054
India 
Phone  07966135655  
Fax  07966135641  
Email  cgautam@clianthatrials.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Charu Gautam 
Designation  Associate VP – Global Clinical Operation 
Affiliation  Cliantha Research Limited 
Address  Sigma-1 Corporate, Off S.G.Highway, Bodakdev, Ahmedabad, Gujarat. Cliantha House, Opp. Pushparaj Tower,Near Judges Bungalow Road, Bodakdev Ahmadabad GUJARAT 380054 India


GUJARAT
380054
India 
Phone  07966135655  
Fax  07966135641  
Email  cgautam@clianthatrials.com  
 
Details of Contact Person
Public Query  
Name  Dr Chirag Shah 
Designation  Head- Clinical Trials 
Affiliation  Cliantha Research Limited 
Address  Sigma-1 Corporate, Off S.G.Highway, Bodakdev, Ahmedabad, Gujarat. Cliantha House, Opp. Pushparaj Tower,Near Judges Bungalow Road, Bodakdev Ahmadabad GUJARAT 380054 India

Ahmadabad
GUJARAT
380054
India 
Phone  07966135631  
Fax  07966135641  
Email  cshah@clianthatrials.com  
 
Source of Monetary or Material Support  
Sponsor: MABXIENCE SA 
 
Primary Sponsor  
Name  MABXIENCE SA 
Address  Yaguarón 1407 Oficina 904 C.P. 11100, Montevideo, Uruguay 
Type of Sponsor  Pharmaceutical industry-Global 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     Argentina
Brazil
India
Peru
Russian Federation
Ukraine  
Sites of Study  
No of Sites = 4  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr C Haritha  Manibhai Shivabhai Cancer Centre, Karamsad  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, India
Ahmadabad
GUJARAT 		 02692222415
02692222400
chiragp@charutarhealth.org 
Dr Sajid Abdul Rehman  Regional Cancer Center, Trivendrum  Department of Medical Oncology, 1st Floor, Regional Cancer Center, Radiation Oncology, Medical College Campus, Trivendrum- 695 011, Kerala, India
Thiruvananthapuram
KERALA 		 04712522497
04712552065
drsajeed.rcc@gmail.com 
Dr Anita Ramesh  Sri RamaChandra Medical Centre, Chennai  Department of Medical Oncology, Sri RamaChandra Medical Centre, No 1, Ramachandra Nagar, Porur, Chennai-600 016, Tamilnadu, India
Chennai
TAMIL NADU 		 04445928828
04445928678
anitachandra100@yahoo.co.in 
Dr Vikas Ostwal  Tata Hospital, Mumbai  Room No. 1222, 12th floor, HBB block, Tata Memorial Hospital, Dr. Ernest Borge Road, Parel, Mumbai-400012, Maharashtra, India
Mumbai
MAHARASHTRA 		 02224177000
02224168604
dr.vikas.ostwal@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 4  
Name of Committee  Approval Status 
Human Ethics Committee, H M Patel Centre for Medical Care and Education, Gokal Nagar, Karamsad  Submittted/Under Review 
Human Ethics Committee, Regional Cancer Center, Medical College Campus, Trivendrum  Submittted/Under Review 
Institutional Ethics Committee, Mumbai  Submittted/Under Review 
Institutional Ethics Committee, Sri RamaChandra Medical Centre  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  patients with metastatic ColoRectal Cancer (mCRC),  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  AVASTIN (Roche/Genentech  Avastin® (5 mg/kg) will be administered initially as a 90-minute infusion 
Intervention  Bevacizumab Biosimilar  Bevacizumab (5 mg/kg) will be administered initially as a 90-minute infusion 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  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. 
 
ExclusionCriteria 
Details  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. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Centralized 
Blinding/Masking   Open Label 
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 
Comparation the safety profile of Bevacizumab and Avastin®, both
administered in combination with FOLFOX (any) or FOLFIRI. 		 At the End of study. i.e. After 12 months. 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="40" 
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   25/08/2014 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  01/09/2014 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Completed 
Recruitment Status of Trial (India)  Completed 
Publication Details   None Yet 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary   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 India (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. 
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