CTRI/2024/06/068269 [Registered on: 03/06/2024] Trial Registered Prospectively
Last Modified On:
20/05/2026
Post Graduate Thesis
No
Type of Trial
Interventional
Type of Study
Biological
Study Design
Randomized, Parallel Group, Active Controlled Trial
Public Title of Study
Comparative biosimilar Denosumab versus Xgeva in patients with bone metastasis from solid tumours
Scientific Title of Study
Comparative pharmacokinetic, pharmacodynamic, safety, efficacy and immunogenicity study of VBDNSM01 (Virchow Denosumab) versus Xgeva (Amgen Denosumab) in patients with bone metastasis from solid tumours
Trial Acronym
Nil
Secondary IDs if Any
Secondary ID
Identifier
VBDNSM01/2023-CT1 Version 3.0 dated 30.10.2023
Protocol Number
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
Dr Hemanth Nandigala
Designation
Medical Officer
Affiliation
Virchow Biotech Private Limited
Address
Virchow Biotech Private Limited,
Plot No 319, 320, 3rd floor East Avenue Swamy Ayappa Society Madhapur,
Hyderabad – 500081
Hyderabad
TELANGANA
500081
India Hyderabad TELANGANA 500081 India
Phone
9866911717
Fax
Email
hemanth@virchowbiotech.com
Details of Contact Person Scientific Query
Name
Dr Hemanth Nandigala
Designation
Medical Officer
Affiliation
Virchow Biotech Private Limited
Address
Virchow Biotech Private Limited,
Plot No 319, 320, 3rd floor East Avenue Swamy Ayappa Society Madhapur,
Hyderabad – 500081
Hyderabad
TELANGANA
500081
India Hyderabad TELANGANA 500081 India
Phone
9866911717
Fax
Email
hemanth@virchowbiotech.com
Details of Contact Person Public Query
Name
Vishaly
Designation
Manager - Medical Affairs and Clinical Operations
Affiliation
Virchow Biotech Private Limited
Address
Virchow Biotech Private Limited,
Plot No 319, 320, 3rd floor East Avenue Swamy Ayappa Society Madhapur,
Hyderabad – 500081
Hyderabad
TELANGANA
500081
India Hyderabad TELANGANA 500081 India
Phone
9866911717
Fax
Email
vishaly@virchowbiotech.com
Source of Monetary or Material Support
Virchow Biotech Private Limited
Primary Sponsor
Name
Virchow Biotech Private Limited
Address
Virchow Biotech Private Limited,
Plot No 319, 320, 3rd floor East Avenue Swamy Ayappa Society Madhapur,
Hyderabad – 500081
Hyderabad
TELANGANA
500081
India
OPD room 2, First floor, Door No- 1-1-83, New Venkojipalem MVP sector 6, NH16, near Hp Petrol Bunk, Visakhapatnam, Andhra Pradesh 530022 Visakhapatnam ANDHRA PRADESH
9873742322
deviims2012@gmail.com
Dr Vijay Pratap Singh
Savera Cancer and Multispeciality Hospital
OPD Room No 1, First floor, Dept of Oncology, Dr. R.N. Singh Road, Lohiya Nagar, Kankarbagh, Near Rajendra Nagar Railway Terminal, Patna Bihar –800020, India Patna BIHAR
9835066460
vijaypsingh_2000@yahoo.com
Dr Lovenish Goyal
Aadhar Health Institute
Room No:101, OPD, Ground floor, Dr. R.N. Singh Road, Lohiya Nagar, Kankarbagh, Near Rajendra Nagar Railway Terminal, Patna Bihar –800020, India Hisar HARYANA
9992853698
aadharresearch@gmail.com
Dr Niraj Bhatt
Aman Hospital and Research Center
Room No:1, Department of Medical Oncology, 15 Shashwat, Gotri
Road, Vadodara, Gujarat -
390021 Vadodara GUJARAT
9727682231
heamatooncologyclinic16@gmail.com
Dr Ravi Sankar
Aster Narayanadri Hospital
Room No.5, ground floor, Dept of Medical Oncology, Renigunta Rd,Tirupati,AP-517506, India Chittoor ANDHRA PRADESH
8919880170
arigela.ravisankar@gmail.com
Dr Ravi Kannan
Cachar cancer hospital and research centre
Room No:2, Department of Surgical Oncology, Opposie
Birbal Bazar, Meherpur,
Silchar,Cachar, Assam788015 Cachar ASSAM
9854040424
Ravi.kannan@cacharcancerhospital.org
Dr Niranjan Hemant Singh
Chandan Cancer Institute Chandan Hospital,
Room No:1, OPD room, Department of Surgical Oncology, Ground floor, Faizabad
Road, Viyant Khand, Gomti
Nagar,Lucknow-UP-226010 Lucknow UTTAR PRADESH
8601670669
dr.hemant2016@gmail.com
Dr Kishore Chandra Korada
Durgabai Deshmukh Hospital & Research Center
OP Room No 1; ground floor, Dept of Oncology, Vidya Nagar ,Hyderabad Hyderabad TELANGANA
9985633083
kishorechandra23@gmail.com
Dr K Velavan
Erode Cancer Centre
Room No1, Ground floor, Dept of Oncology, SH 96, Thindal, Erode, Tamil Nadu 638012 Erode TAMIL NADU
9842334222
kvels@rediffmail.com
Dr Ravindra Nandhana
Government Medical College & Government Geeral Hospital (Old RIMSGGH)
Room No:1 OPD, Department of Oncology, Srikakulam-532001, Andhra Pradesh, India Srikakulam ANDHRA PRADESH
OPD No: 10, First floor, Dept of Oncology, SrikakulamAndhra Pradesh - 532001 India
Srikakulam
ANDHRA PRADESH Srikakulam ANDHRA PRADESH
8942279033
gghsrikakulam@gmail.com
Dr K Lakshmi Priyadarshini
HCG Curie City Cancer Centre
Room No. 2, Ground floor, Dept. of Medical Oncology, 33-25-33, CH Venkata Krishnayya street,Suryarao pet, Vijayawada-520002 Krishna ANDHRA PRADESH
9966030988
priyadarshini006@gmail.com
Dr Raj V Nagarkar
HCG Manavata Cancer Centre
First Floor, OPD Room 3, Dept. of Oncology Opp. Mahamarg Bus Stand, Mumbai Naka, Nashik 422002. Nashik MAHARASHTRA
9823061929
drraj@manavatacancercentre.com
Dr Manish Kumar
Indira Gandhi Institute of Medical Science
Indira Gandhi Institute of Medical Science
Room No: 225, Department of Surgical Oncology, Ward block building, 2nd floor, Block-4
Sheikhpura, Patna-800014 Patna BIHAR
7070810056
ashumishra2287@gmail.com
Dr Kiran A Kittimani
Karnataka Cancer Therapy and Research Institute
Ground floor, OPD, Department of Medical Oncology, Navanagar, Hubli-580025 Dharwad KARNATAKA
8362228217
dr_kittimini@yahoo.com
Kandula Ramu
KIMS Chakra Cancer Center
OP Room No:1. first floor, Dept of Oncology, D.No. 211-3, 222-2A, near Sibar Dental College, Takkellapadu, Peda Kakani Mandal Guntur ANDHRA PRADESH
8125660266
researchmanager@kimschakra.com
Dr Hollis Henry Dsouza
Kkasturi Medicare Private Limited
First Floor, OP room, Department of Medical Oncology, Harshniketan,
Gaoneevi Road, Behind
Navrang Hotel, Bhayandar
West, Dist- Thane, Maharashtra,
401101 Thane MAHARASHTRA
9082805199
drhollisdsouza04@gmail.com
Dr Vikas L
KR Hospital Mysore Medical College and Research Institute
Room No 1, Department of Oncology, Irwin Road, Mysore-570001,Karnataka,India Mysore KARNATAKA
9663099774
vikilaxman@gmail.com
Dr K Pradeep Kumar Reddy
Mahabubnagar cancer Hospital
OPD 2, Dept of Medical Oncology2nd &3rd floor, Arogya complex, opp. Citi endoscan, Rajendra Nagar, Mahbubnagar, Telangana 509001 Mahbubnagar TELANGANA
9902280779
kpkreddy.medonco@gmail.com
Dr Abhishek Kumar Singh
Medanta Hospital
Room No 101, First floor, Dept. of Oncology, Sector - A, Pocket - 1, Amar Shaheed Path, Golf City, Lucknow, Uttar Pradesh 226030 Lucknow UTTAR PRADESH
Institutional Ethics Committee, Government General Hospital
Approved
Institutional Ethics Committee-The Karnataka Cancer Therapy and Research Institute
Approved
Mahabubnagar Cancer Hospital Ethics Committee
Approved
Manavata Clinical Research Institute Ethics Committee
Approved
Om Sai Onco Institutional Ethics Committee
Approved
Savera Cancer and Multispecialty Hospital IEC
Approved
St. Anns Institutional Ethics Committee (SAIEC)
Approved
Regulatory Clearance Status from DCGI
Status
Approved/Obtained
Health Condition / Problems Studied
Health Type
Condition
Patients
(1) ICD-10 Condition: C795||Secondary malignant neoplasm of bone and bone marrow,
Intervention / Comparator Agent
Type
Name
Details
Intervention
VBDNSM01 (Denosumab)
Each single vial contains 120 mg of Denosumab in 1.7 mL of solution (70 mg/mL). Frequency: every 4 weeks; Mode of Administration: Subcutaneous; Duration of treatment: 24 weeks (a total of six doses)
Comparator Agent
Xgeva (Denosumab)
Each single vial contains 120 mg of Denosumab in 1.7 mL of solution (70 mg/mL). Frequency: every 4 weeks; Mode of Administration: Subcutaneous; Duration of treatment: 24 weeks (a total of six doses)
Inclusion Criteria
Age From
18.00 Year(s)
Age To
75.00 Year(s)
Gender
Both
Details
1.Male or female with ≥ 18 to ≤ 75 years.
2.Histological or Cytological confirmation of Breast adenocarcinoma or Prostate cancer or Non-small cell lung cancer.
3.Radiographic evidence of atleast 1 bone metastasis (Confirmed by X-ray, computed tomography, magnetic resonance imaging or bone scan).
4.Eastern Cooperative Oncology Group performance status ≤2.
5.Willing to provide written informed consent and comply with protocol requirements.
6.Able to communicate well with the investigator, to understand and comply with the requirements of the study.
7.Patients of child-bearing potential must agree to use acceptable methods of contraception (as per investigator discretion) during the study. Female patients of child bearing potential must agree to use contraceptive methods for atleast 5 months after the last dose of the drug.
ExclusionCriteria
Details
1.History of hypersensitivity to denosumab or prior use of denosumab.
2.Any of the following oral/dental conditions:
Prior history or current evidence of osteomyelitis or osteonecrosis of the jaw.
Active dental or jaw condition which requires oral surgery.
Planned invasive dental procedure.
Non-healed dental or oral surgery.
3.Administration of intravenous (IV) bisphosphonates, fluoride, or strontium for osteoporosis within the last 1 year or oral bisphosphonates treatment for osteoporosis in last 3 months.
4.Currently enrolled in or has not yet completed at least 30 days (or 5 half-lives, whichever is longer) since ending earlier investigational device or drug trial(s), or patient is receiving another investigational agent(s).
5.Planned bone surgery or radiation to the bone.
6.Life expectancy less than 6 months.
7.Serum calcium levels ≤8 mg/dl.
8.Estimated creatinine clearance ≤30 ml/min.
9.Females with a positive pregnancy test at screening or lactating females.
10.Tested positive for HIV, HCV or HBsAg or known to be tested positive.
11.Un controlled hypertension (Blood pressure ≥ 140 by 90 mm of Hg). Patient on stable antihypertensive medication for more than 3 months with controlled hypertension will be eligible.
12.Any other significant medical condition which in the opinion of the investigator increases the safety risk if patient participate in the trial.
13.Clinically relevant ECG abnormality that affects the successful completion of patient’s treatment in the trial as per investigator.
14.Recent history (within the past 1 year) of myocardial infarction or cerebral stroke or patients with NYHA III or IV heart failure.
15.History of drug or alcohol abuse within the 12 months prior to dosing.
16.Any of the following abnormal investigational values:
a.General: Any laboratory abnormality which, in the opinion of the Investigator, would prevent the patient from safely completing the study or interfere with the interpretation of the study results.
b.Liver transaminases:
i.AST or SGOT ≥2.0 x upper limits of normal ULN;
ii.ALT or SGPT ≥2.0 x ULN;
iii. Alkaline phosphatase and bilirubin ≥1.5 x ULN.
Method of Generating Random Sequence
Computer generated randomization
Method of Concealment
Not Applicable
Blinding/Masking
Not Applicable
Primary Outcome
Outcome
TimePoints
Proportion of patients having skeletal-related events
24 weeks
Secondary Outcome
Outcome
TimePoints
1. Proportion of patients having skeletal-related events at week 12;
week 12
2. Time to first skeletal-related events
0-24 weeks
4. Mean decrease in urinary N-telopeptide adjusted for creatinine (uNTx/Cr) from baseline to week 4, 12, 20 and 24
week 4, 12, 20 and 24
Target Sample Size
Total Sample Size="230" Sample Size from India="230" 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
Randomized, controlled, open-label, multicentre, comparative clinical trial. The primary objective of the study is to evaluate the efficacy of Virchow’s Denosumab (test product) with that of Xgeva (reference product) in patients with bone metastasis from solid tumours. Patients will be randomized in 1:1 ratio to one of the following groups: Group 1: VBDNSM01 (Virchow Biotech - Denosumab) Each single vial contains 120 mg of Denosumab in 1.7 mL of solution (70 mg/mL). Frequency: every 4 weeks; Mode of Administration: Subcutaneous; Duration of treatment: 24 weeks (a total of six doses); Group 2: Xgeva (Amgen - Denosumab) Each single vial contains 120 mg of Denosumab in 1.7 mL of solution (70 mg/mL). Frequency: every 4 weeks; Mode of Administration: Subcutaneous; Duration of treatment: 24 weeks (a total of six doses). Eligible patients will be randomised to receive either Virchow Biotech Denosumab or Xgeva in 1:1 ratio. Patients will receive 120 mg of denosumab every 4 weeks for 24 weeks as a subcutaneous injection in the upper arm, upper thigh, or abdomen as per the randomization.