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CTRI Number  CTRI/2013/05/003699 [Registered on: 29/05/2013] Trial Registered Retrospectively
Last Modified On: 01/06/2016
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-023 and Avastinâ„¢ in patients with Metastatic colorectal cancer 
Scientific Title of Study   Prospective, multi-centre, randomized, open-label, two-arm, parallel group, active-control, comparative clinical study to evaluate efficacy, safety and pharmacokinetics of R-TPR-023 and Avastinâ„¢ when given intravenously in patients with Metastatic colorectal cancer 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
RLS/TP/2012/01; Version 1.0, Dated: 14/02/2012  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Parvez Kosgi 
Designation  Head RLS clinical Trial 
Affiliation  Reliance Life Sciences Pvt. Ltd 
Address  Dhirubhai Ambani Life Sciences Centre R-282 TTC Area of MIDC Rabale Navi Mumbai

Thane
MAHARASHTRA
400701
India 
Phone  02240678000  
Fax  02240678299  
Email  parvez.kosgi@relbio.com  
 
Details of Contact Person
Scientific Query
Modification(s)  
Name  Dr Parvez Kosgi 
Designation  Medical Monitor 
Affiliation  Reliance Life Sciences Pvt. Ltd 
Address  R-282, TTC area of MIDC, Thane-Belapur Road, Rabale, Navi Mumbai

Thane
MAHARASHTRA
400701
India 
Phone  02240678258  
Fax  02240678099  
Email  parvez.kosgi@relbio.com  
 
Details of Contact Person
Public Query  
Name  Dr Parvez Kosgi 
Designation  Head RLS clinical Trial 
Affiliation  Reliance Life Sciences Pvt. Ltd 
Address  Dhirubhai Ambani Life Sciences Centre R-282 TTC Area of MIDC Rabale Navi Mumbai

Thane
MAHARASHTRA
400701
India 
Phone  02240678000  
Fax  02240678299  
Email  parvez.kosgi@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  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
Modification(s)  
No of Sites = 23  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr DiptiRani Samantha Medical Oncologist  Acharya Harihar Regional Cancer Centre  Acharya Harihar Regional Cancer Centre,Medical Road, managalbag, Cuttack-753007
Cuttack
ORISSA 		 09437032728

diptiranisamanta@rediffmail.com 
Dr M R Bardia Director  Acharya Tulsi Regional Cancer Institute & Research Centre  S P Medical College & A G of Hospitals 334003
Bikaner
RAJASTHAN 		 01512226329

directorrrccbkn@gmail.com 
Dr J B sharma Hon Sr Consultant  Action Cancer Hospital  "Action Cancer Hospital, A-4, Paschim Vihar, Room No 806 Clinical Research Dept, New Delhi - 63
New Delhi
DELHI 		 9811167505

Dr_sharmajb@rediffmail.com 
Dr Suresh Attili Medical Oncologist  BIBI Cancer Hospital, & Cancer Centre  BIBI Cancer Hospital, & Cancer Centre, 16-3-991/1/C Govt. printing press road, Malakpet-500024
Hyderabad
ANDHRA PRADESH 		 04024410792

sureshattili@yahoo.com 
Dr Saurabh Prasad Medical Oncology  Central India Cancer Research Institute  Central India Cancer Research Institute 11 Shankar Nagar Wesh High Court Road 400010
Nagpur
MAHARASHTRA 		 7066580511

drsaurabhorasad@yahoo.co.in 
Dr Gopichand Oncosurgeon  City Cancer Centre  City Cancer Centre 35-25-33 Ch Venkata Krishnaiah Street Suryaraopet 520002
Vizianagaram
ANDHRA PRADESH 		 9885256059

mgopichand@yahoo.com 
Dr Rajnish Nagarkar Medical Oncologist  Curie Manavata Cancer Institute  Curie Manavata Cancer Institute Opp Mahamarg Bus stand, Mumbai-Naka,Nashik-422004
Nashik
MAHARASHTRA 		 9823061929

drraj@manavatacancercentre.com 
Dr Rajesh Kumar Grover Director CEO  Delhi State Cancer Institute  "Delhi State Cancer Institute, Dilshad Garden, Delhi-110095"
East
DELHI 		 01122135700

dsci.delhi@yahoo.co.in 
Dr Jaiprakash Baraskar Surgical Oncologist  Dr. Baraskar Hospital and Cancer Care Center  "Dr. Baraskar Hospital and Cancer Care Center Room 05 3rd Floor 278 Central Bazaar Road Ramdaspeth Nagpur 440010
Nagpur
MAHARASHTRA 		 7122420050

jpcancercare2005@yahoo.co.in 
Dr B Sivanesan Medical Oncologist   G. Kuppuswamy Naidu Memorial Hospital  G. Kuppuswamy Naidu Memorial Hospital, Department of Medical Oncology, Pappanaickenpalyam, Coimbatore - 641037
Coimbatore
TAMIL NADU 		 04222245000

bsivanesan@gmail.com 
Dr Ashish Kaushal Medical Oncologist  HCG Cancer Centre  Sola Science City Road Near Sola Bridge S.G. Highway 380060
Ahmadabad
GUJARAT 		 09978297842

drashish4@yahoo.co.in 
Dr Minish Jain Medical Oncologist  K. E. M. Hospital  Day Care Centre 3rd Floor Banoo Modliar Road Rasta Peth 411011
Pune
MAHARASHTRA 		 9823133390

drminishjain@yahoo.co.in 
Dr Niraj Bhatt Medical Oncologist  Kailash Cancer Hospital & Research Centre  Kailash Cancer Hospital & Research Centre,Muni Seva Ashram, Goraj-391760, Vaghodia, Vadodara
Vadodara
GUJARAT 		 02668-268038

munisevaashram@yahoo.co.in 
Dr Yathish Medical Oncologist  Karnataka cancer Hospital & Research Centre  Karnataka cancer Hospital & Research Centre, #99 Jharakabande, Krsihananda Nagar, nadini Layout Post, Bangalore- 560096
Bangalore
KARNATAKA 		 08023574160

dryathish@hotmail.com 
Dr Krishna Prasad Medical Oncologist  Kasturba Medical College Hospital  Department of Medical Oncology, Attavar, Mangalore - 575001
Dakshina Kannada
KARNATAKA 		 0824445858

drkrishnaprasad@hotmail.com 
Dr Unmesh Takalkar Oncosurgeon  Kodlikeri Memorial Hospital  8 Manjeet Nagar Opp. Akashwani Jalna Road, 431005
Aurangabad
MAHARASHTRA 		 09822042425

unmesh_3@sancharnet.in 
Dr Suraj Pawar General Surgery  Kolhapur Cancer Centre  Kolhapur Cancer Centre R-S 238 Opposite Mayur Petrol Pump Gokul Shirgaon Karveer 416234
Kolhapur
MAHARASHTRA 		 9822014908

surajpawar2001@yahoo.co.in 
Dr Murli Krishna Voona Surgical Oncologist  Mahatma Gandhi Cancer Hospital & Research Institute  Mahatma Gandhi Cancer Hospital & Research Institute (A unit of Vizag Hospital & Cancer Centre Pvt Ltd) 1/7 MVP Colony 530017
Visakhapatnam
ANDHRA PRADESH 		 9848191287

murlivoona@yahoo.com 
Dr Kirushna Kumar HeadOncology  Meenakshi Mission Hospital  1st Floor Department Of Medical Oncology Lake Area Melur Road 625107
Madurai
TAMIL NADU 		 09787713004

drkskk@yahoo.com 
Dr Sathya Radiation Oncologist  Mysore Medical College & Research Institute  Mysore Medical College & Research Institute & Associated hossitals Irwin Road 570021
Mysore
KARNATAKA 		 9901040001

sathya_678@hotmail.com 
Dr Tushar Patil Medical Oncologist  Sahyadri Speciality Hospital  30/C Karve Road Erandwane 411004
Pune
MAHARASHTRA 		 09552522556

tussipats@hotmail.com 
Dr R S Arora Oncosurgeon  Sujan Surgical Cancer Hospital & Amravati Cancer Foundation  Sujan Surgical Cancer Hospital & Amravati Cancer Foundation, 52/B Shankar Nagar Main Road, Amravati-444606
Amravati
MAHARASHTRA 		 09823097573

dr_rsaroa2@rediffmail.com 
Dr Tanveer Maksud medical Oncologist  Unique Hospital Multispeciality & Research Institute  Unique Hospital Multispeciality & Research Institute Opp Kiran Motors Canal Road Civil Hospital Char Rasta-Sosyo Circle lane Off Ring Road 395002
Surat
GUJARAT 		 9909918887

tanveermaksud@yahoo.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 23  
Name of Committee  Approval Status 
Acharya Harihar Regional Cancer Centre Institutional Ethics Committee  Approved 
Action Cancer Hospital ethics Committee  Approved 
Amravati Ethics Committee  Approved 
BIBI Institutional Ethics Committee  Approved 
Central India Cancer Research Institute Ethics Committee  Approved 
Delhi State Cancer Institute Institutional Ethics Committee  Approved 
Ethical Review Board, Meenakshi Mission Hospital & Research Center, Madurai  Approved 
Ethics Committee KEM Hospital & Research Centre  Approved 
Ethics Committee Unique Hospital  Approved 
Ethics Committee, Kodlikeri Memorial Hospital & CIIGMA Hospital , Aurangabad  Approved 
HCG Multispeciality Ethics Committee  Approved 
Institutional Ethics Committee City Cancer Centre  Approved 
Institutional Ethics Committee GKNM  Approved 
Institutional Ethics Committee Mysore Medical College  Approved 
Institutional Ethics Committee S P Medical College & A G of Hospitals  Approved 
Institutional Ethics Committee, Baraskar Hospital & Research Centre  Approved 
Institutional Ethics Committee,Karanataka Cancer Hospital, Bangalore  Approved 
Kailash cancer & Medical centre Institutinal Ethics Committee  Approved 
Kolhapur Cancer Centre Institutional Ethics Committee  Approved 
Mahatma Gandhi Cancer Hospital & research institute Institutional Review Board  Approved 
Manavta Clinical Research Institute  Approved 
Manipal Univeristy Ethics Committee  Approved 
Sahyadri Hospital Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Patients with Metastatic colorectal cancer,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Avastinâ„¢  Dose: 5 mg/kg, Frequency: Every 2 weeks, Route of Administration: Intravenously, Duration: 3 years 
Intervention  R-TPR-023  Dose: 5 mg/kg, Frequency: Every 2 weeks, Route of Administration: Intravenously, Duration: 3 years. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1. Patient must have histologically or cytologically confirmed colorectal adenocarcinoma with metastatic disease documented on diagnostic imaging studies.
2. Patient must have measurable lesions as defined by modified Response Evaluation Criteria in Solid Tumors (RECIST) criteria. Patients who agree to undergo the Magnetic Resonance Imaging (MRI) studies must have a metastatic lesion that is >2 cm.
3. Patient must not have previously received chemotherapy for metastatic disease.
4. Patients with estimated life expectancy >6 months
5. Patient may have received adjuvant therapy for primary colorectal cancer provided that at least 6 months have elapsed from the time the adjuvant therapy was concluded and recurrent disease was documented. .
6. Eastern Cooperative Oncology Group (ECOG) performance status 0-2
7. Patients must have adequate organ and marrow function as defined below: ・
• Absolute neutrophil count (ANC) ≥1,500/mm3;
• Platelets ≥100,000/ mm3; hemoglobin ≥9 gm/dL (may be transfused to maintain or exceed this level);
• Total Bilirubin ≤1.5 within institutional upper limit of normal (IULN); AST or SGOT/ALT or SGPT ≤ 2.5 times IULN, or ≤ 5 times IULN if known liver metastases;
• Serum Creatinine ≤1.5 x IULN
8. Patients must have an International Normalized Ratio (INR) less than/equal to 1.5 and a Partial thromboplastin time (PTT) less than/equal to 1.5 IULN.
9. Patients with history of hypertension must be well-controlled (blood pressure less than/equal to 150/100), on a stable regimen of anti-hypertensive therapy.
10. Females of childbearing potential should be willing to use an approved method of double-barrier contraception and have to have a negative pregnancy test.
11. Able to understand the study procedures, the risks involved, willing to provide written Informed Consent, and able to adhere to study schedules and requirements. 
 
ExclusionCriteria 
Details  1. Participation in other clinical trial within 4 weeks of first infusion of this study.
2. Prior full field radiotherapy less than/equal to 4 weeks or limited field radiotherapy less than/equal to 2 weeks prior to treatment.
3. History or presence of central nervous system metastases.
4. Patient with history of prior treatment with bevacizumab or other agents targeting vascular endothelial growth factor (VEGF).
5. Known dihydropyrimidine dehydrogenase deficiency.
6. Patients with a history of allergic reactions attributed to compounds of similar chemical or biologic composition to bevacizumab, irinotecan, 5-FU, or leucovorin.
7. Serious non-healing wound, ulcer, or active bone fracture.
8. Major surgical procedure, open biopsy or significant traumatic injury within 28 days prior to Day 0; anticipation of need for major surgical procedure during the course
of the study.
9. Fine needle aspirations or core biopsies within 7 days prior to Day 0.
10. Current or recent use of full-dose warfarin (except as required to maintain patency of preexisting, permanent indwelling IV catheters) for subjects receiving warfarin, INR should be 1.5). Patients may have prophylactic use of low molecular weight heparin; however therapeutic use of heparin or low molecular weight heparin is not acceptable.
11. Evidence of bleeding diathesis or coagulopathy.
12. Patients with a history of another primary malignancy less than/equal to 5 years, with the exception of non-melanoma skin cancer, and carcinoma in situ of uterine
cervix.
13. History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to Day 0, unless affected area has been removed surgically.
14. Any of the following concurrent severe and/or uncontrolled medical conditions which could compromise participation in the study: Uncontrolled high blood pressure,
history of labile hypertension, or history of poor compliance with an antihypertensive regimen; Unstable angina; New York Heart Association (NYHA) greater than/equal to
grade 2 congestive heart failure
15. Myocardial infarction within 6 months of study enrollment; History of stroke within 6 months of study enrollment; Unstable symptomatic arrhythmia requiring medication (Patients with chronic atrial arrhythmia, i.e., atrial fibrillation or paroxysmal supraventricular tachycardia are eligible); Clinically significant peripheral vasculardisease; Uncontrolled diabetes; Serious active or uncontrolled infection
16. History of other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that might affect the interpretation of the results of the study or render the subject at high risk from treatment complications.
17. Inability to comply with study and/or follow-up procedures.
18. Subjects with HIV, HBsAg, HCV test positive.
19. Any other condition which investigator feels would pose a significant hazard to subject if bevacizumab or chemotherapy 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 Objective Response Rate (Complete Response and Partial Response) by RECIST 1.1 criteria at 25 weeks  25 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
1. To assess the disease progression free survival (PFS) rate And evaluate ORR at 25 weeks and 1 years
2. To determine single dose pharmacokinetics of R-TPR-023 and Avastinâ„¢
3. To evaluate overall survival (OS) rate at 2 years, 3 years and 5 years.
4. Evaluation of safety 		 1. progression free survival (PFS) rate And evaluate ORR at 25 weeks and 1 years
2. overall survival (OS) rate at 2 years, 3 years and 5 years 
 
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)
Modification(s)  		 26/06/2013 
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="3"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Closed to Recruitment of Participants 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary
Modification(s)  

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-023 and Avastinâ„¢ in patients with Metastatic colorectal cancer.

The primary outcome measures will be to assess the efficacy as overall response rate (Complete Response and Partial Response) assessed by RECIST 1.1 criteria at 25 weeks.  
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