CTRI/2024/04/066032 [Registered on: 19/04/2024] Trial Registered Prospectively
Last Modified On:
27/10/2025
Post Graduate Thesis
No
Type of Trial
Interventional
Type of Study
Drug Biological
Study Design
Randomized, Parallel Group Trial
Public Title of Study
A study to evaluate the efficacy, safety and immunogenicity of Bevacizumab in metastatic colorectal cancer patients.
Scientific Title of Study
A Prospective, Randomized, Double Blind, Multicentric, Parallel Group Phase-III Clinical Study to Evaluate the Efficacy, Safety, and Immunogenicity of BP01 (Bevacizumab) Versus EU approved Avastin® along with chemotherapy XELOX in metastatic colorectal cancer patients.
Trial Acronym
NIL
Secondary IDs if Any
Secondary ID
Identifier
ICS/CUR/2023-006 Version 1.0 19 OCT 2023
Protocol Number
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
Kartik Sahni
Designation
Director
Affiliation
Insignia Clinical Services Pvt. Ltd.
Address
Insignia Clinical Services Pvt. Ltd. Room # 512, Clinical Trial Division, Clinical
Operations Department, Best Sky Tower, Netaji Subhash Place, Pitampura North
West Delhi, India
North West DELHI 110034 India
Phone
9868679414
Fax
Email
kartik.sahni@insigniacs.com
Details of Contact Person Scientific Query
Name
Dr Arpitkumar Prajapati
Designation
General Manager
Affiliation
CuraTeQ Biologics Private Ltd.
Address
CuraTeQ Biologics Private Ltd. Galaxy, Floors 22-24, Survey No. 83/1, Hyderabad
Knowledge City, Hyderabad, Telangana, India
Hyderabad TELANGANA 500081 India
Phone
8455255222
Fax
Email
arpitkumar.Prajapati@curateqbio.com
Details of Contact Person Public Query
Name
Kartik Sahni
Designation
Director
Affiliation
Insignia Clinical Services Pvt. Ltd.
Address
Insignia Clinical Services Pvt. Ltd. Room # 512, Clinical Trial Division, Clinical
Operations Department, Best Sky Tower, Netaji Subhash Place, Pitampura North
West Delhi, India
North West DELHI 110034 India
Phone
9868679414
Fax
Email
kartik.sahni@insigniacs.com
Source of Monetary or Material Support
CuraTeQ Biologics Private Ltd. Galaxy, Floors 22-24, Survey No. 83/1, Hyderabad Knowledge City,
Hyderabad, Telangana, India, 500081
Department of Oncology Mahavir Status Beside KP Heights Nr Manmohan crossroad, New Nikol 382053 Ahmadabad GUJARAT
9909914228
drkkp23@gmail.com
Dr Sulabhchandra Bhamare
Maxcure Hospital
Department of Oncology, Narayan Sonawane Marg Old D Souza Colony Jehan Circle Behind Suzuki Showroom Gangapur Road- 422005 Nashik MAHARASHTRA
9373244670
drsulabhchandra@gmail.com
DrKanu Priya Bhatia
Mohandai Oswal Cancer Treatment and Research Foundation Mohandai Oswal Hospital
Grand Trunk Road, Bypass Sherpur, Ludhiana, Punjab 141009 Ludhiana PUNJAB
9711886530
bhatiakanu13@gmail.com
Dr Bellala Ravi Shankar
Omega Hospital
Clinical Research Department, First Floor
Chinnagadhili, Health City,
Arilova, Hanumanthuwaka
530040 Visakhapatnam ANDHRA PRADESH
9849123256
drbravisankar@gmail.com
Dr Lokesh K N
Radhakrishna Multispeciality Hospital and IVF Centre
3/4 Sunrise Tower J P Road Girinagar 560085 Bangalore KARNATAKA
8971609070
Drlokeshkn.rmh@gmail.com
Dr Lokanath Dasappa
RL Jallapa Hospital and Research Centre
Attached to Sri Devaraj URS Medical College Tamaka Kolar 563101 Kolar KARNATAKA
9845695589
drlok61@gmail.com
Dr Seema Devi
State Cancer Institute, Indira Gandhi Institute of Medical Sciences
Department of Oncology Sheikhpura Patna 800014 Patna BIHAR
7250925205
doctorseema71@gmail.com
DrMukesh Kumar
State Cancer Institute, SMS Medical College & Attached Hospital
Department of Medical Oncology, State Cancer Institute, SMS Medical College & Attached Hospital, JLN Marg, Jaipur 302004, Rajasthan, India
Jaipur RAJASTHAN
9413464059
mukeshrulania008@gmail.com
DrRajender Singh Arora
Sujan Surgical Cancer Hospital & Amravati Cancer Foundation,Amravati
Amravati Ethics Committee Sujan Surgical Cancer Hospital and Research
Approved
Apex Wellness Ethics Committee - AWEC
Approved
Central Ethics Committee SDUAHER
Approved
ETHICS COMMITTEE OF BMCRI
Approved
Ethics Committee S.M.S. Medical College and Attached Hospitals
Approved
Ethique De La Nature Association
Approved
IEC BGS Global Institute of Medical Sciences
Approved
IEC King George Hospital
Approved
IEC Mohandai Oswal Cancer Treatment Research Foundation
Approved
IEC VENKATESHWAR HOSPITAL UNIT OF ASHA
Approved
Institute Ethics Committee All India Institute of Medical Sciences
Approved
Institutional Ethics Committee VMMC & SJH Vardhman Mahavir Medical College & Safdarjung Hospital
Approved
Institutional Ethics Committee Erode Cancer Center
Approved
Institutional Ethics Committee HCG Curie City Cancer Center
Approved
Institutional Ethics Committee, IGIMS
Approved
INSTITUTIONAL REVIEW BOARD MAHATMA GANDHI CANCER HOSPITAL RESEARCH INSTITUTE
Approved
INSTITUTIONNAL HUMAN ETHICS COMMITTEE -DEEPA HOSPITA
Approved
Kashyap Memorial Eye Hospital Ethics Committee
Approved
KCC Institutional Ethics Committee
Approved
KEM Hospital Research Centre Ethics Committee
Approved
MAHAVIR HOSPITAL ETHICS COMMITTEE
Approved
Manavata Clinical Research Institute Ethics Committee
Approved
Shree Siddhivinayak Hospital Ethics Committee
Approved
Thangam Hospital - Institutional Ethics Committee
Approved
The Chairman Institutional Ethics Committee HCG Cancer Centre
Approved
TMH Institutional Ethics Committee-I
Approved
Regulatory Clearance Status from DCGI
Status
Approved/Obtained
Health Condition / Problems Studied
Health Type
Condition
Patients
(1) ICD-10 Condition: C189||Malignant neoplasm of colon, unspecified, (2) ICD-10 Condition: C20||Malignant neoplasm of rectum,
Intervention / Comparator Agent
Type
Name
Details
Intervention
BP01 (Bevacizumab 400mg)
Dose of 7.5 mg/kg body weight to be administered intravenously every 21 days for 06 cycles
Comparator Agent
EU approved Avastin® (Bevacizumab 400mg)
Dose of 7.5 mg/kg body weight to be administered intravenously every 21 days for 06 cycles
Inclusion Criteria
Age From
18.00 Year(s)
Age To
99.00 Year(s)
Gender
Both
Details
1. Male and female patients 18 years and above.
2. Histopathologically confirmed colorectal cancer.
3. Diagnosis of metastatic colorectal cancer which is not amenable to curative surgery and or radiation.
4. Patients who have not received any treatment for metastatic colorectal cancer [i.e. only 1st line mCRC patients].
5. Measurable disease on radiological assessment according to RECIST 1.1 criteria.
6. Subjects with Eastern Cooperative Oncology Group (ECOG) PS 0 or 1 at the time of screening and before the first infusion.
7. Have a life expectancy of at least 4 months as per the investigator.
8. The Patient is able to understand and is willing to give informed consent and is able to comply with the requirements of the study protocol.
9. A woman of childbearing potential must have a negative highly sensitive serum (beta human chorionic gonadotropin [beta-hCG]) at screening and urine beta-hCG test at randomization.
10. Women of childbearing potential and men must be using two acceptable methods of contraception, (e.g., intra-uterine device plus condom, spermicidal gel plus condom, diaphragm plus condom, etc.) for the entire duration of the study from the time of screening and 4 months following the completion of therapy.
ExclusionCriteria
Details
1. Received prior chemotherapy for metastatic disease [chemotherapy for primary disease is acceptable].
2. Prior treatment with bevacizumab.
3. History of haemoptysis, thrombotic or haemorrhagic event in the past 6 months.
4. Therapeutic anticoagulation; regular use of aspirin (325 mg per day), NSAIDs, or agents known to inhibit platelet function.
5. Radiation therapy for metastatic disease or surgery within 1 month of randomization.
6. Serious non-healing wound or bone fracture.
7. Known hypersensitivity to bevacizumab, capecitabine, or oxaliplatin.
8. Urine protein on dipstick analysis ≥ 2+ [If urine protein is more than 2+, further assessments should show urine protein: creatinine ratio 0.5 grams protein per gram creatinine by urinalysis OR total urinary protein 1,000 mg by 24-hour urine collection for inclusion.
9. Patients with known dihydropyrimidine dehydrogenase (DPD) deficiency.
10. High levels of SGOT 3 x ULN and 5 x ULN in patients with liver metastasis. Serum bilirubin 1.5 X ULN.
11. Patients with known or suspected brain metastases. Patients with a history of CNS metastases are eligible if they have been successfully treated and are off steroids for at least 4 weeks before randomization.
12. Patients with a history of prior malignancy other than colorectal cancer.
13. Other invasive malignancies within the past 5 years except for nonmelanoma skin cancer and successfully treated cervical carcinoma in situ.
14. Patients with severe renal impairment (estimated creatinine clearance below 30 mL per min) study.
15. Patients with a current history of drug and alcohol abuse.
16. Patient in the opinion of the investigator is not capable of complying with the study.
17. The patient is unable or unwilling to give written informed consent.
18. The patient has participated in an investigational drug study within the last one month.
19. Receipt of IV antibiotics for infection within 14 days of randomization.
20. Any condition for which, in the opinion of the investigator, participation would not be in the best interest of the participant (e.g., compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments.
21. History of hepatitis B surface antigen (HBsAg) or hepatitis C antibody (anti-HCV) positive, or other clinically active liver disease, or tests positive for HBsAg or anti-HCV at Screening.
22. History of human immunodeficiency virus (HIV) antibody positive, or tests positive for HIV.
23. Received an investigational intervention (including investigational live vaccines) or used an invasive investigational medical device within 30 days or 5 half-lives before the Baseline, whichever is longer, before signing the consent.
Method of Generating Random Sequence
Computer generated randomization
Method of Concealment
Centralized
Blinding/Masking
Participant, Investigator and Outcome Assessor Blinded
Primary Outcome
Outcome
TimePoints
Objective response rate (ORR) as per RECIST Version 1.1
Day 127
Secondary Outcome
Outcome
TimePoints
Objective response rate (ORR)
Day 64
Overall survival
Day 127
Progression Free Survival
Day 127
Disease Control Rate
Day 127
Incidence and Titres of Anti-Bevacizumab Antibodies between both groups.
Baseline, Day 43 and Day 127
Treatment Emergent Adverse Events (TEAEs)
Day 127
Target Sample Size
Total Sample Size="168" Sample Size from India="168" Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials" Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials"
Individual Participant Data (IPD) Sharing Statement
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
Brief Summary
Colorectal cancer (CRC) commonly known as colon
cancer, or rectal cancer is characterized by the uncontrolled proliferation of
cells in the colon or rectum. It is the third most common cancer and the fourth
most common cause of cancer-related death. Most cases of CRC are detected in
Western countries, with its incidence increasing year by year. An aging
population, unfavorable diet, smoking, sedentary lifestyle, chronic disease,
low physical activity, and obesity are a few factors that contribute to the
risk of colorectal cancer in developed countries.
Thisis a Prospective Phase III, Multicentric,
Comparative, Randomized, Double-blind, Active Controlled, Parallel group
clinical study to evaluate and compare the efficacy, immunogenicity and safety
of BP01(Bevacizumab) mfg. by CuraTeQ Biologics Private Limited with reference
medicinal product EU approved Avastin® (Bevacizumab of Roche) along with
chemotherapy XELOX in metastatic colorectal cancer patients.