| CTRI Number |
CTRI/2025/01/079222 [Registered on: 22/01/2025] Trial Registered Prospectively |
| Last Modified On: |
29/05/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Biological |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A clinical trial to study safety and efficacy of Bevacizumab in the Treatment of Metastatic Colorectal Cancer in 200 patients |
|
Scientific Title of Study
|
A prospective multicenter Open labelled Phase IV study to Establish the Safety &
efficacy of Biosimilar Bevacizumab of Enzene Biosciences Ltd in Combination with Chemotherapy in Patients with Metastatic Colorectal Cancer |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| ALK33/ENZ137-BEV2 Version 1 Dated 28 Aug 2023 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Akhilesh Sharma |
| Designation |
President & Chief Medical Officer |
| Affiliation |
Alkem Laboratories Limited |
| Address |
Alkem Laboratories Limited, Alkem House, Devashish, Adjacent to
Matulya centre, Senapati Bapat Marg, Lower Parel, Mumbai,
MAHARASHTRA 400013, India
Mumbai (Suburban)
MAHARASHTRA
400013
India |
| Phone |
02239829999 |
| Fax |
|
| Email |
akhilesh.sharma@alkem.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vinayaka Shahav |
| Designation |
General Manager- Clinical Research |
| Affiliation |
Alkem Laboratories Limited |
| Address |
Alkem Laboratories Limited, Alkem House, Devashish, Adjacent to
Matulya centre, Senapati Bapat Marg, Lower Parel, Mumbai,
MAHARASHTRA 400013, India
Mumbai (Suburban)
MAHARASHTRA
400013
India |
| Phone |
02239829999 |
| Fax |
|
| Email |
vinayaka.shahavi@alkem.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vinayaka Shahav |
| Designation |
General Manager- Clinical Research |
| Affiliation |
Alkem Laboratories Limited |
| Address |
Alkem Laboratories Limited, Alkem House, Devashish, Adjacent to
Matulya centre, Senapati Bapat Marg, Lower Parel, Mumbai,
MAHARASHTRA 400013, India
Mumbai (Suburban)
MAHARASHTRA
400013
India |
| Phone |
02239829999 |
| Fax |
|
| Email |
vinayaka.shahavi@alkem.com |
|
|
Source of Monetary or Material Support
|
| Alkem Laboratories Limited Alkem House Senapati Bapat Marg Lower Parel Mumbai 400013 Maharashtra |
| Enzene Biosciences Ltd, Plot No A 22 A/ 1 2 Chakan Industrial Area Phase 2 Khalumbre
Chakan Pune 410501 Maharashtra India |
|
|
Primary Sponsor
|
| Name |
Enzene Biosciences Limited |
| Address |
Enzene Biosciences Ltd, Plot No A 22, A/ 1/ 2 Chakan Industrial
Area, Phase 2, Khalumbre, Chakan, Pune 410501, Maharashtra,
India. |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Alkem Laboratories Limited |
ALKEM HOUSE DEVASHISH Adjacent to
Matulya centre Senapati Bapat Marg Lower
Parel west Mumbai 400013 |
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 7 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Deepak Sundriyal |
All India Institute of Medical Sciences |
Virbhadra Marg, Pashulok Rishikesh, Dehradun, uttarakhand-249203, India
Dehradun
UTTARANCHAL |
9968175838
drdeepaksundriyal@gmail.com |
| Dr R Suresh Kumar |
Deepa Hospital (Indian Cancer Centre) |
486,2nd stanes St, Odakkadu, KNP Puram, Tiruppur-641602, Tamil Nadu
Coimbatore
TAMIL NADU |
9487018787
drrsk21@gmail.com |
| Dr Velavan Kandappan |
Erode Cancer Centre |
1/393, Velavan Nagar, Perundurai Road, Thindal, Erode-638012, Tamil Nadu, India
Erode
TAMIL NADU |
9842334222
kvels@rediffmail.com |
| Dr Raj Nagarkar |
HCG Manvata Cancer Centre |
Clinical Research Department, 1st floor, Behind Shivang Auto, Mumbai Naka, Maharashtra 422002
Nashik
MAHARASHTRA |
9823061929
drraj@manavatacancercentre.com |
| Dr Nilesh Dhamne |
Kolhapur Cancer Centre |
R.S. 238, Opp. Mayur Petrol Pump, Gokul Shirgaon, Kolhapur 416234
Kolhapur
MAHARASHTRA |
7738245698
dr.nilesh.gmc@gmail.com |
| Dr Vikas Ostwal |
Tata Memorial Hospital |
Dr. E. Borges Road, Parel, Mumbai 400012
Mumbai
MAHARASHTRA |
9702288801
dr.vikas.ostwal@gmail.com 9702288801 |
| Dr Vijay Patil |
Tieten Medicity Hospital |
4th floor Sunact cancer institute Pvt. Ltd., Kasarvadavli, ghodbandar road, Thane, 400615
Thane
MAHARASHTRA |
9136129135
vijaypgi@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 13 |
| Name of Committee |
Approval Status |
| BGS-Global Institute of Medical Sciences, Institutional ethics Committee |
Submittted/Under Review |
| Ethics Committee relating to Clinical trial, All India Institute of Medical Sciences, Rishikesh |
Approved |
| Ethics Committee S.M.S. Medical College and Attached Hospitals |
Submittted/Under Review |
| Instituional Ethics committee-I, Tata Memorial Hospital |
Approved |
| Institutional Ethics Committee III, TMC ACTREC Tata Memorial Centre ACTREC Sector 22, Near Owe camp Kharghar Navi Mumbai Raigad Maharashtra - 410210 India |
Submittted/Under Review |
| Institutional ethics Committee, All India Institute of Medical Sciences, Bhubaneswar |
Submittted/Under Review |
| Institutional Ethics Committee, Erode Cancer Centre |
Approved |
| Institutional Human Ethics Committee, Deepa Hospital |
Approved |
| KCC Institutional Ethics Committee |
Approved |
| Manavata Clinical Research Institute Ethics Committee |
Approved |
| MNJIO & RCC Ethics Committee |
Submittted/Under Review |
| Nirmal Hospital Ethics Committee |
Submittted/Under Review |
| Vedant Hospital Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C189||Malignant neoplasm of colon, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Biosimilar Bevacizumab |
Dose per cycle can be decided as per investigator discretion that is
5 mg/kg every 2 weeks with bolus-IFL
10 mg/kg every 2 weeks with FOLFOX4
5 mg/ kg every 2 weeks or 7.5 mg/kg every 3 weeks with fluoropyrimidine irinotecan or fluoropyrimidine-oxaliplatin-based chemotherapy after progression
on a first-line bevacizumab product containing regimen
The initial dose (Cycle 1) should be delivered over 90 minutes as an intravenous infusion.
If the first infusion (Cycle 1) is well tolerated, the second infusion (Cycle 2) may be administered over 60 minutes. If the 60-minute infusion is well tolerated, all subsequent infusions may be administered over 30 minutes. |
| Comparator Agent |
NA |
NA |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
The subjects will be included in the study based on the following criteria
Willing to provide voluntary written informed consent
Male or Female subjects between 18 to 80 years of age (both inclusive)
Has life expectancy of at least 6 months at the time of screening
Histologically or cytologically confirmed metastatic colorectal cancer (Stage IV i.e. Metastatic disease, at least M1 as per AJCC TNM classification)
Measurable disease (RECIST criteria version 1.1), based on radiographic studies
performed prior to enrollment
Eastern cooperative oncology group (ECOG) status 0 to 2 at the time of screening
Willing and able to comply with the protocol. |
|
| ExclusionCriteria |
| Details |
Patient with potentially resectable metastatic disease as per investigator clinical judgment.
History of hemoptysis, thrombotic or hemorrhagic event in past 6 months
History of wound healing complications.
Therapeutic anticoagulation, regular use of aspirin, NSAIDs or agents known to inhibit platelet function
Surgery (other than minor interventions like diagnostic biopsy or intravenous port implantation) or irradiation within 28 days before enrollment
Patients with major trauma within the 28 days before enrollment or non-fully healed wound or any other clinically relevant wound or ulcer at the time of dosing or anticipated need for elective surgery during the study duration
History of abdominal fistula, tracheoesophageal fistula, gastrointestinal perforation, diverticulitis or intra-abdominal abscess within the 6 months before screening or any chronic gastrointestinal disease causing diarrhea of a severity above CTCAE grade 1.
History of active gastro duodenal ulcer within 4 weeks prior to screening
Known hypersensitivity to any component of the investigational product and other medications used in this study
Patients with a non-healed fracture
History of hypersensitivity to Chinese Hamster Ovary (CHO) cell products or other recombinant human or humanised antibodies.
Clinical evidence of brain metastasis or leptomeningeal involvement
History of Interstitial Lung Disease or pulmonary fibrosis
Patients with history of peripheral sensory neuropathy
Patients with history of Rhabdomyolysis
Patients with coagulopathy
Myocardial infarction within 6 months prior to screening
Symptomatic congestive heart failure (New York Heart Association [NYHA] Grade 3 or 4), unstable angina pectoris within 6 months prior to screening, significant cardiac arrhythmia, history of stroke or transient ischemic attack within 1 year prior to screening
Uncontrolled hypertension defined as systolic blood pressure more than 150 mm Hg and/or diastolic blood pressure more than 90 mm Hg despite medication and/or prior history of hypertensive emergencies
Patients having the following laboratory results at screening
Absolute neutrophil count (ANC) less than 1,500/mm3
Hemoglobin (Hb) less than 9 g/dL
Total Leucocyte count less than 3000/mm3
Platelet count less than 100,000/mm3
Total bilirubin level more than 1.5 times the upper limit of the normal laboratory range (ULN)
AST and ALT more than 1.5 x ULN (more than 5.0 x ULN if liver metastases are present)
Alkaline phosphatase more than 2.5 x ULN (more than 5.0 x ULN if liver or bone metastases are present)
Serum Creatinine level more than 1.25 x ULN
INR and aPTT more than 1.5 x ULN
Proteinuria: 3+
Patients suffering from acute or chronic infection(s)
Positive serology for human immunodeficiency virus (HIV), hepatitis B virus (HBV) and hepatitis C virus (HCV) at screening
Patients who are not willing to use adequate contraception during the study period
Female patients who are pregnant or nursing
Has any concurrent disease or condition, which in the opinion of the investigator does not allow participation of the patient in this study
Has participated in any other clinical trial and received experimental medications within 4 weeks prior to screening |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Treatment emergent serious and non-serious adverse events (AEs)
Alteration in clinical laboratory parameter |
Treatment emergent serious and non-serious adverse events (AEs) from Visit 1 to Visit 6
Alteration in clinical laboratory parameter during the study period |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To evaluate the best overall response rate defined as proportion of patients achieving complete response [CR] or partial response [PR] as per response evaluation criteria in solid tumors (RECIST) version 1.1 at the EOS
To evaluate the Disease control rate defined as proportion of patients achieving complete response [CR] or partial response [PR] or stable disease [SD] as per response evaluation criteria in solid tumors (RECIST) version 1.1 at the EOS Change in ECOG at EOS |
From Baseline to Week 8/12 |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
07/02/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
A prospective, multicenter, Open labelled, Phase IV study to Establish the Safety & efficacy of Biosimilar Bevacizumab of Enzene Biosciences Ltd. in Combination with Chemotherapy in Patients with Metastatic Colorectal CancerTwo Hundred (200) patients will be enrolled in the study.
The study shall consist of following periods.
Screening Period: It will last up to 21 days during which the patient will be assessed for eligibility in the study; Treatment Period: It will either be 6 weeks with a 2-week therapy duration or 9 weeks with a 3-week therapy duration. Therapy will consist of 4 cycles of Biosimilar Bevacizumab with Chemotherapy regimen of Physicians choice; Follow-up Period: 2 - 3 weeks after completion of Treatment Period depending on the chemotherapy regimen decided by the physician.
Primary Endpoint: Treatment emergent serious and non-serious adverse events (AEs) Alteration in clinical laboratory parameters
Secondary Endpoint To evaluate the best overall response rate defined as proportion of patients achieving complete response [CR] or partial response [PR] as per response evaluation criteria in solid tumors (RECIST) version 1.1 at the EOS To evaluate the Disease control rate defined as proportion of patients achieving complete response [CR] or partial response [PR] or stable disease [SD] as per response evaluation criteria in solid tumors (RECIST) version 1.1 at the EOS Change in ECOG at EOS
|