CTRI/2019/09/021256 [Registered on: 16/09/2019] Trial Registered Prospectively
Last Modified On:
23/09/2022
Post Graduate Thesis
No
Type of Trial
Interventional
Type of Study
Biological
Study Design
Randomized, Parallel Group, Active Controlled Trial
Public Title of Study
A clinical trial to study the safety and efficacy of biosimilar cetuximab in patients with recurrent locoregional or metastatic squamous cell carcinoma of the head and neck.
Scientific Title of Study
A prospective, multicenter, randomized, double blind, parallel group study to compare the efficacy and safety of biosimilar cetuximab versus innovator cetuximab in combination with
platinum-based chemotherapy in patients with recurrent locoregional or metastatic squamous cell carcinoma of the head and neck (SCCHN).
Trial Acronym
Secondary IDs if Any
Secondary ID
Identifier
ALK18/ENZ124-CET1; v_02 Date: 27-Mar-2019
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 Ltd
Address
Alkem Laboratories Ltd. Unit no. 301, 3rd floor, Marathon Innovo, ‘B’ Wing, Opp. Peninsula Corporate Park, Ganpatrao Kadam Marg, Lower Parel (West), Mumbai, MAHARASHTRA-400013, India
Mumbai MAHARASHTRA 400013 India
Phone
022-39829999
Fax
Email
akhilesh.sharma@alkem.com
Details of Contact Person Scientific Query
Name
Dr Akhilesh Sharma
Designation
President & Chief Medical Officer
Affiliation
Alkem Laboratories Ltd
Address
Alkem Laboratories Ltd. Unit no. 301, 3rd floor, Marathon Innovo, ‘B’ Wing, Opp. Peninsula Corporate Park, Ganpatrao Kadam Marg, Lower Parel (West), Mumbai, MAHARASHTRA-400013, India
Mumbai MAHARASHTRA 400013 India
Phone
022-39829999
Fax
Email
akhilesh.sharma@alkem.com
Details of Contact Person Public Query
Name
Dr Vinayaka Shahavi
Designation
Associate General Manager, Clinical Research
Affiliation
Alkem Laboratories Limited
Address
Alkem Laboratories Ltd. Unit no. 301, 3rd floor, Marathon Innovo, ‘B’ Wing, Opp. Peninsula Corporate Park, Ganpatrao Kadam Marg, Lower Parel (West), Mumbai, MAHARASHTRA-400013, India
Kolhapur Cancer center Pvt Ltd, R S 238, opp. Mayur petrol pump, Gokul Shirgaon, Kolhapur 416234 Kolhapur MAHARASHTRA
7738245698
dr.nilesh.gmc@gmail.com
Dr Hemant Malhotra
Mahatma Gandhi Hospital
Department of Medical Oncology
Mahatma Gandhi Medical College Hospital
Mahatma Gandhi University of Medical Sciences and Technology Sitapura Jaipur Jaipur RAJASTHAN
9892062040
drmalhotrahemant@gmail.com
Dr Manu Prasad A
Malabar Cancer Center, Kannur
Department of Clinical Hematology & Medical Oncology, Malabar Cancer Centre, P.O Moozhikara,
Thalassery, Kannur-670103 Kannur KERALA
4902355881
manuprasadmcc@gmail.com
Dr Ananda Selva Kumar Pandy
Meenakshi Mission Hospital and Research Centre,
Lake Area, Melur Road,
Madurai-625107 Madurai TAMIL NADU
9787713004
drask81@yahoo.co.in
Dr PK Chaithanya
MNJ Institute of Oncology and Regional Cancer Centre
MNJ Institute of Oncology and Regional Cancer Centre, Red Hills, Lakidikapul, Near Niloufer Children Hospital, Hyderabad- 500 004, Telangana, India Hyderabad TELANGANA
8897199994
chaitanyakrishna.medonc@gmail.com
Dr Vashista Pankaj Maniar
Mumbai Oncocare Centre
2nd Floor , Majithia Apratments, God’s Gift Premises Co-op . society Ltd, S V Road, Irla, Vile Parle (W), Mumbai -400056 Mumbai MAHARASHTRA
9819834571
vpm@mocindia.co.in
Dr Prakash SS
Mysore Medical college and Research Institute and K.R. Hospital
Mysore Medical college and Research Institute and K.R. Hospital, Irwin Road, Mysore – 570 001, Karnataka, India Mysore KARNATAKA
Department of Radiation Oncology, Regional Cancer Center, Medical College Campus, Post Box No. 2417, Trivandrum, Kerala, India 695011 Thiruvananthapuram KERALA
9447072333
rejnish@yahoo.com
Dr Chandan Krushna Das
Regional Cancer Center, PGIMER, Chandigarh
Department of Radiotherapy & Oncology, Regional
Cancer Centre, PGIMER (Post Graduate Institute of
Medical Education and Research), Chandigarh, Sector
12, Pin Code-160012,INDIA Chandigarh CHANDIGARH
9968846608
ckdasoncology@gmail.com
Dr Kartar Singh
RST Regional Cancer Hospital and Research Center, Nagpur
RST Regional Cancer Hospital and Research Center, Manewada Road, Tukdoji Chowk, Nagpur 440027 Nagpur MAHARASHTRA
7020795655
drkartarsingh1972@gmail.com
Dr Rohitashwa Dana
SMS Medical College and Hospital
Department- Surgery, SMS Medical College & Attached Hospital’s, J.L.N. Marg, Jaipur- 302001, Rajasthan Department of Radio-therapy, SMS Medical College and Attached Hospitals, J.L.N. Marg, Jaipur- 302001 Jaipur RAJASTHAN
9414129654
rdana2000@yahoo.co.in
Dr Ambalathandi Ravi Chandran
Sri Ramachandra Medical College and Research Institute
Sri Ramachandra Medical College and Research Institute, No. 01, Ramachandra Nagar, Porur, Chennai– 600 116, Tamil Nadu, India Chennai TAMIL NADU
9703436255
raviambalathandi@gmail.com
Dr Sanjoy Chatterjee
Tata Medical Center, Kolkata
TATA Medical Center, 14 Major Arterial Road (EW), Newtown, Rajarhat, Kolkata- 700160 Kolkata WEST BENGAL
03366057403
sanjoy.chatterjee@tmckolkata.com
Dr Kumar Prabhash
TATA Memorial Hospital
TATA Memorial Hospital, Dr. Ernest Borges Road, Parel Mumbai – 400 012, Maharashtras, India Mumbai MAHARASHTRA
Institutional Ethics Committee, RST Regional Cancer Center, Nagpur
Approved
Institutional Ethics Committee, TATA Medical Center, Kolkata
Approved
Institutional Ethics Committee, TATA Memorial Hospital
Approved
KEM Hospital Research Centre Ethics Committee
Approved
KLES Dr. Prabhakar Kore Hospital & M.R.C., IEC
Approved
Kolhapur Cancer Centre Institutional Ethics Committee
Approved
Meenakshi Mession Hospital, IEC
Approved
MNJ Institute of Oncology & Regional Cancer Centre Ethics Committee
Approved
Mumbai Oncocare Centre Institutional Ethics Committee
Approved
Mysore Medical college and Research Institute and K.R. Hospital
Approved
Nirmal Hospital Ethics Committee
Approved
SMS medical college, IEC
Approved
Sri Narsimha Saraswati Medical Foundation Ethics Committee
Approved
Sudhbhawana Hospital, IEC
Approved
Regulatory Clearance Status from DCGI
Status
Approved/Obtained
Health Condition / Problems Studied
Health Type
Condition
Patients
(1) ICD-10 Condition: C148||Malignant neoplasm of overlappingsites of lip, oral cavity and pharynx,
Intervention / Comparator Agent
Type
Name
Details
Intervention
Biosimilar Cetuximab
Dosage Form: It will be supplied in concentration of 5 mg/mL as a 100 mg/20 ml single-use vial, as a sterile, injectable liquid containing no preservatives.
Dosage: The initial dose is 400 mg per m2 to be administered as an IV infusion over a period
of 120 mins, subsequently Cetuximab shall be administered at a dose of 250 mg per m2 per week(visit 2 to visit18) as an IV infusion over a period of 60 minute
Comparator Agent
Innovator Cetuximab
Dosage Form: It will be supplied in concentration of 5 mg/mL as a 100 mg/20 ml single-use
vial, as a sterile, injectable liquid containing no preservatives.
Dosage: The initial dose is 400 mg per m2
to be administered as an IV infusion over a period
of 120 mins, subsequently Cetuximab shall be administered at a dose of 250 mg per m2
per
week(Cycle 2 to Cycle 18) as an IV infusion over a period of 60 minutes.
Inclusion Criteria
Age From
18.00 Year(s)
Age To
65.00 Year(s)
Gender
Both
Details
1.Patients of 18-65 years of age at the time of signing the ICF
2.Has life expectancy of at least 6 months from screening
3. Histologically confirmed diagnosis of SCCHN
4. Presence of recurrent locoregional (not suitable for local therapy) or metastatic disease as per Tumor Node Metastasis staging at screening
5. In case of recurrent locoregional carcinoma, patients must have documented progression of platinum-based chemotherapy for recurrent disease
6. Has at least 1 measurable target lesion (tumor/lymph node) as per RECIST version 1.1 at screening
7. Eastern cooperative oncology group (ECOG) status 0 to 2 at screening
8. Willing and able to comply with the protocol
9. Willing to provide written informed consent
ExclusionCriteria
Details
1.Patients with Nasopharyngeal cancer
2.Prior systemic chemotherapy (except if given as part of a multimodal treatment for locally advanced disease which was completed more than 6 months prior to screening)
3.Patient who has received cetuximab or other EGFR targeting agent treatment (except if given as part of a multimodal treatment for locally advanced disease which was completed more than 6 months prior to screening)
4.Surgery (other than minor interventions like diagnostic biopsy or intravenous port implantation) or irradiation within 30 days before randomization
5.Concomitant anti-tumor therapy or concomitant immunotherapy
6.Known sensitivity to any component of the investigational product (IP) and medication used in this study
7.Clinical evidence of brain metastasis or leptomeningeal involvement
8.History of Interstitial Lung Disease
9.History of severe (Grade 3 or 4) allergic or hypersensitivity reaction to therapeutic antibodies
10.Patient’s having the following laboratory results at screening
a.Absolute neutrophil count (ANC) < 1,500/mm3
b.Hemoglobin (Hb) < 9 g/dL
c.Total Leucocyte count < 3000/mm3
d.Platelet count < 100,000/mm3
e.Total bilirubin level > 1.5 times the upper limit of the normal laboratory range (ULN)
f. Alanine aminotransferase (ALT)/aspartate aminotransferase (AST) levels ≥ 5 times ULN
g.Serum Creatinine level > 1.5 times ULN
h.Abnormal serum electrolytes (within normal limit)
i. INR and aPTT (within normal limit)
11.Patients suffering from acute or chronic infection(s)
12.Myocardial infarction within 6 months prior to screening
13.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
14. Pre-existing grade 2 or greater motor or sensory neuropathy
15. Active hemoptysis (defined as bright red blood of ½ teaspoon or more in saliva) within 30 days prior to randomisation.
16.History of clinically significant gastrointestinal bleeding (bleeding requiring procedural intervention (e.g., variceal banding, transjugular intrahepatic portosystemic shunt procedure, arterial embolization, topical coagulation therapy) within 6 months prior to randomisation.
17.Patients with history of keratitis
18.Positive serology for human immunodeficiency virus (HIV), hepatitis B virus (HBV) and hepatitis C virus (HCV) at screening
19.Female patients of childbearing potential not willing to implement adequate non-hormonal contraceptive measures during the study period
20.Patients who are pregnant or nursing
21.Has any concurrent disease or condition, which in the opinion of the investigator does not allow participation of the patient in this study
22.Has participated in any other clinical trial and received experimental medications within 4 weeks prior to screening.
Method of Generating Random Sequence
Computer generated randomization
Method of Concealment
Centralized
Blinding/Masking
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
Primary Outcome
Outcome
TimePoints
1. To compare the efficacy of biosimilar cetuximab versus innovator cetuximab in patients with recurrent locoregional or metastatic SCCHN by assessment of Disease Control
Rate (DCR)
2.To compare the efficacy of biosimilar cetuximab versus innovator cetuximab in patients with recurrent locoregional or metastatic SCCHN by assessment of overall response
rate (ORR)
1. All patients completed 12 week of treatment
2. All patients completed 18 weeks of treatment
Secondary Outcome
Outcome
TimePoints
1. Pharmacokinetics (PK) of biosimilar versus innovator cetuximab
2.Immunogenicity of biosimilar cetuximab and innovator cetuximab by assessment of
anti-cetuximab antibody (ADA)
Anti-cetuximab antibody (ADA): baseline and Week 18 visit
PK Assessment:Baseline, Week2,3 and 4
Target Sample Size
Total Sample Size="180" Sample Size from India="180" 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)?
Brief Summary
The primary and secondary purpose behind conducting this trial are: 1. To compare the efficacy of biosimilar cetuximab versus innovator
cetuximab in patients with recurrent locoregional or metastatic SCCHN by
assessment of Disease Control Rate (DCR) and Overall Control Rate (ORR)
2. To compare Pharmacokinetics (PK) of biosimilar versus innovator
cetuximab, immunogenicity of biosimilar cetuximab and innovator cetuximab by
assessment of anti-cetuximab antibody, safety and tolerability of the
investigational product.