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CTRI Number  CTRI/2015/06/005909 [Registered on: 15/06/2015] Trial Registered Prospectively
Last Modified On: 10/12/2018
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug
Biological 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A clinical trial to study the effects of two drugs, R-TPR-033 and Erbitux® in patients with head and neck cancer of squamous cell type that has spread to other part of the body 
Scientific Title of Study   Prospective, multi-centric, randomized open-label, two arm, parallel group, active-control, comparative clinical study to evaluate efficacy, safety and pharmacokinetics of R-TPR-033 / Erbitux® in patients with recurrent locoregional or metastatic squamous cell carcinoma of the head and neck 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
RLS/ONC/2013/04 Version 2.0, Dated 24 March 2014  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Prashant Pandya 
Designation  General Manager- Clinical Development 
Affiliation  Reliance Life Sciences Pvt.Ltd 
Address  Reliance Life Sciences Pvt.Ltd Dhirubhai Ambani Life Sciences Centre R-282 TTC Area of MIDC Rabale Mumbai Maharashtra 400701, India.

Thane
MAHARASHTRA
400701
India 
Phone  02240678236  
Fax  02240678299  
Email  prashant.pandya@relbio.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Sanjeev Hegde 
Designation  Reliance Life Sciences Pvt.Ltd 
Affiliation  Reliance Life Sciences Pvt.Ltd 
Address  Reliance Life Sciences Pvt.Ltd Dhirubhai Ambani Life Sciences Centre R-282 TTC Area of MIDC Rabale Mumbai Maharashtra 400701, India.

Thane
MAHARASHTRA
400701
India 
Phone  0224067000  
Fax  02240678299  
Email  sanjeev.hegde@relbio.com  
 
Details of Contact Person
Public Query  
Name  Dr Prashant Pandya 
Designation  General Manager- Clinical Development 
Affiliation  Reliance Life Sciences Pvt.Ltd 
Address  Reliance Life Sciences Pvt. Ltd., Dhirubhai Ambani Life Sciences Centre, R-282 TTC Area of MIDC, Rabale, Navi Mumbai Maharashtra 400701, India.

Mumbai
MAHARASHTRA
400701
India 
Phone  02240678236  
Fax  02240678299  
Email  prashant.pandya@relbio.com  
 
Source of Monetary or Material Support  
Reliance Life Sciences Pvt. Ltd. Dhirubhai Ambani Life Sciences Centre Plot R-282, TTC Area of MIDC Thane Belapur Road, Rabale, Navi Mumbai 400 701. India  
 
Primary Sponsor  
Name  Reliance Life Sciences Pvt Ltd 
Address  Reliance Life Sciences Pvt. Ltd. Dhirubhai Ambani Life Sciences Centre Plot R-282, TTC Area of MIDC, Thane Belapur Road Rabale, Navi Mumbai 400 701. India.  
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 14  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Jadhav Kirankumar  B.J. Govt Medical College  1st Floor, surgery Department, Block # 10, B. J. Govt Medical College & Sasoon General Hospitals, Pune Station, Pune – 411001 MAHARASHTRA.
Pune
MAHARASHTRA 		 9823949126

drkpjadhav@gmail.com 
Dr Shrikant Khare  Curie Manavata Cancer Institute  Department of Radiation Oncology, Basement, Main Building, Curie Manavata Cancer Centre, Opp Mahamarg Bus Stand, Mumbai Naka, Nashik, Maharastra – 422004, India
Nashik
MAHARASHTRA 		 9021545797

drshrikantkhare@gmail.com 
Dr Jaiprakash Baraskar  Dr. Baraskar Hospital and Cancer Care Center   276 Crystal Plaza, Second Floor, Research Department, Baraskar Hospital & Research Care Centre, Ramdas Peth, Nagpur-440010.
Nagpur
MAHARASHTRA 		 7122420050

jpcancercare2005@yahoo.co.in 
Dr A Rajkumar  G Kuppuswamy Naidu Memorial Hospital  Department of Medical Oncology, G. Kuppuswamy Naidu Memorial Hospital,P. O. Box 6327, P.N. Palayam-641037 Coimbatore, TAMIL NADU.
Coimbatore
TAMIL NADU 		 9894563864

draprince@yahoo.com 
Dr Ashok Diwan  Government Medical College & Hospital  Department of Radiation Oncology, Ground Floor, Government Medical College & Hospital, Nagpur-440003
Nagpur
MAHARASHTRA 		 9822816608

tinuad_07@hotmail.com 
Dr Ashish Kaushal  HCG Cancer Centre  Department of Medical Oncology, Ground Floor, OPD area, HCG Cancer Centre, Sola Science City Road, Near Sola Bridge, S. G. Highway, Ahmedabad-380060.
Ahmadabad
GUJARAT 		 9978297842

drashish4@yahoo.co.in 
Dr Jyothi N  Karnataka cancer Hospital & Research Centre  Clinical Research Department, 1st floor, Karnataka Cancer Hospital, #99 J.B. Kaval, Krishnanandanagar, Nandhini Lay Out, Bangalore Pin Code- 560096 Bangalore KARNATAKA
Bangalore
KARNATAKA 		 9448051964

jyothichinnali@yahoo.com 
Dr Sathya M   KR Medical College & Hospital, Mysore Medical College and Research Institute  Department of Radiation, Ground Floor, KR Medical College & Hospital, Mysore Medical College and Research Institute, Irwin Road, Mysore-570001
Mysore
KARNATAKA 		 9901040001

Sathya_678@hotmail.com 
Dr R Vijayabhaskar  Meenakshi Mission Hospital & Research Centre  Department of Radiation Oncology, Meenakshi Mission Hospital & Research Centre, Lake Area, Melure Road, Madurai - 625107, Tamilnadu.
Madurai
TAMIL NADU 		 9443647481

drvijayabhaskar@gmail.com 
Dr Bala Sankar  MNJ Institute of Oncology & Regional Cancer Centre  Department of RadioTherapy, MNJ Institute of Oncology & Regional Cancer Centre,Red Hills, Lakdi Ka Pool, Hyderabad, Telangana - 500004
Hyderabad
ANDHRA PRADESH 		 9963696117

sankarrmc2004@yahoo.co.in 
Dr Shanmuga Kumar  Rajiv Gandhi Government General Hospital  Room No 116, Clinical Research Room, Department of Radiation Oncology, Rajiv Gandhi Government General Hospital, Park Town, Opp. Central Railway station, Chennai 600003 TAMIL NADU
Chennai
TAMIL NADU 		 9441442322

drssk57@yahoo.co.in 
Dr Suresh Sudailaiandi  Sri Ramachandra University  Department of Medical Oncology, Sri Ramachandra University, No.1 Ramachandra Nagar, Porur, Chennai - 600 116 Tamil Nadu, India.
Chennai
TAMIL NADU 		 9841217766

drsureshonco@gmail.com 
Dr Nikunj Vithlani  Unique Hospital Multispeciality & Research Centre  Clinical Research Department, Basement, Unique Hospital- Multispecialty & Research Institute, Opp. Kiran Motor, Canal Road, Civil Hospital, Char Rasta- Sosyo Circle Lane, Off Ring Road Dist. Surat– 395002, Gujarat, India
Surat
GUJARAT 		 9879204250

drnikunjvithalani@gmail.com 
Dr Amrut Kadam  Victoria Hospital, Bangalore Medical College & Research Institute  Department of Radiotherapy, Victoria Hospital, City Market, Bangalore Medical College & Research Institute, Bangalore-560 002
Bangalore
KARNATAKA 		 9986545999

raysoflife@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 15  
Name of Committee  Approval Status 
Ethics Committee, Bangalore Medical College & Research Institute  Submittted/Under Review 
Institutional Ethics Committee of BJ Govt. Medical College and Sassoon Government Hospital  Submittted/Under Review 
Institutional Ethics Committee, G. Kuppuswamy Naidu Memorial Hospital  Approved 
Institutional Ethics Committee, Government Medical College & Hospital  Submittted/Under Review 
Institutional Ethics Committee, HDG Multi Speciality Hospital & HCG Cancer Centre  Submittted/Under Review 
Institutional Ethics Committee, Madras medical college & Rajiv Gandhi Government General Hospital  Submittted/Under Review 
Institutional Ethics Committee, Meenakshi Mission Hospital and Research Centre  Approved 
Institutional Ethics Committee, Mysore Medical College and Research Institute and associated Hospitals  Submittted/Under Review 
Institutional Ethics Committee, Sri Ramachandra University  Approved 
Institutional Ethics Committee, Unique Hospital Multispeciality & Research Centre  Approved 
Institutional Ethics Committee,Karanataka Cancer Hospital, Bangalore  Submittted/Under Review 
Jasleen Hospital Ethics Committee, Nagpur  Submittted/Under Review 
Kolhapur Cancer Centre Ethics Committee  Submittted/Under Review 
Manavta Clinical Research Institute Ethics Committee  Approved 
MNJ Institute of Oncology and Regional Cancer Centre Ethics Committee  Submittted/Under Review 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Patients with recurrent loco regional or metastatic squamous cell carcinoma of the head and neck.,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Erbitux  Manufactured by Eli Lilly & Co.; Dose and Frequency: Subjects will receive initial dose of 400 mg/m2 (over 2 hours) followed by weekly doses of 250 mg/ m2 (over 1 hour); Route: IV; Duration: 24 weeks 
Intervention  R-TPR-033   Manufactured by Reliance Life Sciences Pvt. Ltd.; Dose and Frequency: Subjects will receive initial dose of 400 mg/m2 R-TPR-033(over 2 hours) followed by weekly doses of 250 mg/ m2 (over 1 hour); Route: IV; Duration: 24 weeks 
 
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.
2.Histologically or cytologically confirmed recurrent locoregional or metastatic squamous-cell carcinoma of the head and neck that is not suitable for
local therapy
3.Patients must have documented progression of platinum-based chemotherapy for R/M disease
4.At least one lesion that is measurable by computed tomography (CT) or magnetic resonance imaging (MRI) as defined by Response Evaluation Criteria in Solid Tumors (RECIST) criteria version 1.1
5.Eastern Cooperative Oncology Group (ECOG) performance status ≤2.
6.Estimated life expectancy >4 months
7.ANC ≥1.5x109/L, Platelets ≥100x109/L, Hemoglobin >9.0 g/dL, Serum Creatinine ≤ 1.5 ULN and Total bilirubin ≤ 1.5 mg/dL.
8.INR and aPTT ≤1.5× ULN.
9.Serum creatinine ≤1.5× ULN, or creatinine clearance ≥50 mL/min
10.Patient or Legally Acceptable Representative able to comprehend and give written informed consent for the study and willing to come for follow-up visits as per protocol requirements
 
 
ExclusionCriteria 
Details  1. Nasopharyngeal cancer
2. Prior treatment with an investigational or approved agent for the purpose of inhibiting HER family members
3. Last anti-tumor therapy within 4 weeks before Cycle 1, Day 1.
4. Diagnosis of concurrent second malignancy or leukemia
5. Active autoimmune disease that is not controlled by non-steroidal anti-inflammatory drugs
6. Symptomatic hypercalcemia.
7. History of bleeding diathesis or coagulopathy other than that due to anticoagulation therapy
8. Active hemoptysis
9. Clinically significant gastrointestinal bleeding within 6 months prior to Cycle 1
10. History of Interstitial Lung Disease
11. History of severe (Grade 3 or 4) allergic or hypersensitivity reaction to therapeutic antibodies.
12. Clinical or Radiological evidence of Primary central nervous system malignancy or
13. Major surgical procedure or significant traumatic injury within approximately 28 days prior to randomization
14. Severe dyspnoea
15. Pre-existing grade 2 or greater motor or sensory neuropathy
16. Women who are pregnant, lactating, or women of childbearing potential who are not using effective contraception.
17. Serious underlying medical condition.
18. Subject participation in another clinical trial within 90 days prior to administration of IP.
19. Previous use of non-human monoclonal antibody therapy
20. Current severe, uncontrolled acute or chronic systemic disease
Any other condition which investigator feels would pose a significant hazard to subject, if IP is administered.  
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Centralized 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Outcome Name: Efficacy will be assessed as BOR (Best Overall Response) by RECIST 1.1 criteria   week 18  
 
Secondary Outcome  
Outcome  TimePoints 
• To assess efficacy as Disease Control Rate
• To determine disease progression free survival (PFS) rate
• Objective Response Rate
• To determine duration of objective response To determine time to progression
• To evaluate Overall Survival (OS)
• Pharmacokinetics of R-TPR-033 and ErbituxR
• Evaluation of safety
• Pharmacodynamic studies of anti-EGFR activity
• To study immunogenicity
 		 week 24 
 
Target Sample Size   Total Sample Size="105"
Sample Size from India="105" 
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 3 
Date of First Enrollment (India)   25/06/2015 
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="5"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Other (Terminated) 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

This is a prospective, multi-centre, open-label, two-arm, parallel group, active-control, randomized comparative clinical study. The present study will evaluate the efficacy

safety and pharmacokinetics of R-TPR-033 and Erbitux in patients with recurrent loco regional or metastatic squamous cell carcinoma of the head and neck.

The primary outcome measures will be to assess the efficacy as Best overall response rate assessed by RECIST 1.1 criteria

 
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