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CTRI Number  CTRI/2015/03/005607 [Registered on: 04/03/2015] Trial Registered Retrospectively
Last Modified On: 21/06/2017
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug
Biological
Other (Specify) [Recombinant]  
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A clinical trial to study the effects of two drugs, R-TPR-029/ Neulasta® (Neulastim®) in Patients with suffering from Chemotherapy induced Neutropenia. 
Scientific Title of Study   Prospective, multi-centric, open label, two arm, parallel group, active control, randomized, comparative clinical study to evaluate efficacy and safety of R-TPR-029/ Neulasta® (Neulastim®) when given subcutaneously in patients with Chemotherapy Induced Neutropenia. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
RLS/TP/2011/01, Version 5, dated 24th Mar 2014  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Sanjeev Hegde 
Designation  Head- Clinical Development 
Affiliation  Reliance Life Sciences Pvt. Ltd 
Address  Dhirubhai Ambani Life Sciences Centre R-282 TTC Area of MIDC Rabale Mumbai Maharashtra, India.

Thane
MAHARASHTRA
400701
India 
Phone  02267678208  
Fax  02267678299  
Email  sanjeev.hegde@relbio.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Pravin Ghadge  
Designation  Medical Monitor 
Affiliation  Reliance Life Sciences Pvt. Ltd 
Address  Dhirubhai Ambani Life Sciences Centre R-282 TTC Area of MIDC Rabale Mumbai Maharashtra 400701, India.

Thane
MAHARASHTRA
400701
India 
Phone  02267678431  
Fax  02240678299  
Email  pravin.ghadge@relbio.com  
 
Details of Contact Person
Public Query
 
Name  Dr Sanjeev Hegde 
Designation  Head- Clinical Development 
Affiliation  Reliance Life Sciences Pvt. Ltd 
Address  Dhirubhai Ambani Life Sciences Centre R-282 TTC Area of MIDC Rabale Mumbai Maharashtra, India.

Thane
MAHARASHTRA
400701
India 
Phone  02267678208  
Fax    
Email  sanjeev.hegde@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, 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, Rabale, Navi Mumbai 400 701.  
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 16  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Ajay Sharma  Acharya Tulsi Regional Cancer Centre, Bikaner  Research cell, room No.113/114, First floor, Acharya Tulsi Regional Cancer Institute & Research Centre S P Medical College & A G of Hospitals Bikaner-334003 Rajasthan India
Bikaner
RAJASTHAN 
0151-2522297

ajaysharmaspmcbkn@gmail.com 
Dr Suresh Attilli  BIBI Genral Hospital, Hyderabad  Department of Oncology, 3rd floor, Clinical research division, Bibi General Hospital and Cancer Centre, 16-3-991/1/C Govt. Printing Press Road, Malakpet, Hyderabad - 24
Hyderabad
ANDHRA PRADESH 
040-24410792

sureshattili@yahoo.com 
Dr Vijay Palwe  Curie Manavta - HCG, Nashik  Department of Radiation Oncology, Basement Main Building, Curie Manavata Cancer Institute Opp Mahamarg Bus stand, Mumbai-Naka,Nashik-422004
Nashik
MAHARASHTRA 
9969390250

drvijaypalwe@yahoo.co.in 
Dr Ashok Diwan  Government Medical College, Nagpur  Department of Radiation Oncology,Ground floor, Government Medical College and Hospital, Medical College Square, Nagpur -440003
Nagpur
MAHARASHTRA 
07122701612

tinuad_07@hotmail.com 
Dr Shirish Alurkar  HCG Cancer Centre, Ahmedabad  Department of Medical Oncology, Grounf floor, OPD area, Sola Science City Road Near Sola Bridge S.G Highway Ahmadabad-380060 Gujarat India
Ahmadabad
GUJARAT 
9824048666

ssalurkar@gmail.con 
Dr Chandrashekhar Mahakalkar  Jawaharlal Nehru Medical College, Wardha  Department of Surgery 2nd floor, Datta Meghe Institute of Medical Sciences (Deemed University), Jawaharlal Nehru medical College, Acharya Vinoba Bhave Rural Hospital, Swangi (Meghe), Wardha 442004, Maharashtra
Wardha
MAHARASHTRA 
9822369277

cmahakalkar@rediffmail.com 
Dr Smita Kayal  JIPMER, Puduchery  Deaprtment of Medical Oncology, Jawaharlal Institute of Post-Graduate Medical and Educational Research, Dhanvantri Nagar, Puducherry -605006
Pondicherry
PONDICHERRY 
914132272380

kayalsmita@rediffmail.com 
Dr V Srinivasan  Kamakshi Memorial Hospital, Chennai  Oncology Department, Dr. Kamakshi Memorial Hospital Pvt. Ltd No. 1 radial Road, Pallikaranai, Chennai
Chennai
TAMIL NADU 
9841022366

vsrinivasan09@gmail.com 
Dr Yatheesh Kumar H M  Karnataka Cancer Hospital, Bangalore  Karnataka cancer Hospital & Research Centre, #99 Jharakabande, Krsihananda Nagar, nadini Layout Post, Bangalore- 560096
Bangalore
KARNATAKA 
080-23574160

dryathish@hotmail.com 
Dr Suraj Pawar  Kolhapur Cancer Centre  Kolhapur Cancer Centre, R-S 238, Opposite Mayur Petrol Pump, Gokul Shirgaon, Karveer, Kolhapur
Kolhapur
MAHARASHTRA 
9822014908

kolhapurcancercentre@gmail.com 
Dr Rushi Panchal  Manibhai Shivabhai Patel Cancer centre, Gujarat  Ground Floor,Manibhai Shivabhai Patel Cancer centre, Shree Krishna Hospital & Medical Research Centre, Gokal Nagar, Karamsad
Anand
GUJARAT 
9727757165

rusp2582@yahoo.co.in 
Dr Rakesh Neve  Noble Hospital, Pune  Clinical Research Department, 1st floor, Noble Hospital Pvt. Ltd, 153, Magarpatta City Road, Pune 411013
Pune
MAHARASHTRA 
9881143410

rakesh.neve@gmail.com 
Dr K K Singh  Pravara Rural Hospita, Loni  Clinical Research Department, Basement Main Building, Pravara Rural Hospital & Medical College of Pravara Institute of Medical Sciences (Deemed University), A/P Loni; Tal: Rahata; Ahmednagar - 413736
Ahmadnagar
MAHARASHTRA 
02422271302

drkksingh61@gmail.com 
Dr Makadia  Shree Giriraj Multispeciality Hospital, Rajkot  Clinical Research Department, Shree Giriraj Multispeciality Hospital, 15 Feet Ring Road, 27 - Navjyot Park Main Road, Amin Marg Cross Road, Rajkot - 360005
Rajkot
GUJARAT 
02812587087

makadiamonali@yahoo.co.in 
Dr Vimal Batra  SSG Hospital, Vadodara  Department of radiotherapy, SSG Hospital, Medical college Baroda, Near Jail Road, Vadodara
Vadodara
GUJARAT 
9825350509

vimalbatra@rediffmail.com 
Dr Rajendersingh Arora  Sujan Surgical Cancer Hospital & Amravati Cancer Foundation  Sujan Surgical Cancer Hospital & Amravati Cancer Foundation, 52/B Shankar Nagar Main Road, Amravati-444606
Amravati
MAHARASHTRA 
9823097573

dr_rsarora@rediffmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 12  
Name of Committee  Approval Status 
Amravati Ethics Committee  Approved 
BIBI Institutional Ethics Committee  Approved 
Ethics Committee S. P. Medical College and A. G. of Hospitals, Bikaner  Approved 
HCG Multispeciality Ethics Committee   Approved 
Human Reasearch Ethics Committee  Approved 
Institutional Ethics Committee, Government Medical College, Nagpur  Approved 
Institutional Ethics Committee, Mahatma Gandhi Cancer Hospital & Research Institute, Visakhapatnam  Approved 
Institutional Ethics Committee, Pravara Institute of Medical Sciences-Deemed University, Ahmednagar  Approved 
Institutional Ethics Committee,Karanataka Cancer Hospital, Bangalore  Approved 
Kolhapur Cancer Centre Institutional Ethics Committee  Approved 
Manavata Clinical Research Institutional Ethics Committee,  Approved 
Shree Giriraj Hospital Research Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Patients suffering from chemotherapy induced Neutropenia,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Neulasta® (Neulastim®)  Dose 6 mg, Frequency Every 21 days, Route of administration subcutaneous, Duration 4 cycles (of 21 days each) 
Intervention  R-TPR-029  Dose:6 mg, Frequency Every 21 days, Route of administration is subcutaneous, Duration 4 cycles (of 21 days each) 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1. Adult patients of either sex in the age group of 18 to 65 years
2. Patients scheduled to receive myelosuppressive chemotherapy regimens.
3. Any previous chemotherapy exposure should have been completed >3 weeks before randomization and no more than 1 cycle of chemotherapy for the existing disease is allowed before randomization into the present study.
4. Patients with high risk or intermediate risk of developing chemotherapy-induced febrile neutropenia as per NCCN guidelines.
5. Patients planned and eligible to undergo at least 4 cycles of chemotherapy after randomization.
6. Eastern Cooperative Oncology Group (ECOG) performance status ≤2.
7. Adequate hematologic function
8. Estimated life expectancy >6 months
9. Females of childbearing potential should be willing to use an approved method of contraception.
10. 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. Known active acute or chronic infection
2. Pregnant or breastfeeding women, and women not practicing effective contraception.
3. Known hypersensitivity to the active ingredient or other product constituents.
4. Patients with history of radiation within 4 weeks before the first cycle of chemotherapy in the study
5. Patient is on bleomycin- or carbazitaxel-containing chemotherapy regimen
6. Patient with body weight 45 kg
7. Previous bone marrow or stem-cell transplantation
8. Diagnosis of concurrent second malignancy
9. Serious inter-current chronic or acute illness
10. Systemic autoimmune disorder and/or chronic use of immunosuppressive agents during the 6 weeks prior to the first cycle of chemotherapy in the study
11. History of chemotherapy causing delayed myelosuppression
12. Concurrent use of other granulocyte colony stimulating growth factors
13. Received prophylactic antibiotics within the preceding 6 weeks.
14. Patients with neuropathy of grade 2 or higher.
15. Impaired renal or hepatic function.
16. Any other medical condition, which in opinion of the investigator, may affect patient’s participation in the study
17. Patient’s participation in another clinical trial 90 days prior to administration of IP.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Duration of Grade 4 neutropenia will be measured in days in patients receiving R-TPR-029 / Neulasta® (Neulastim®)   Duration of Grade 4 neutropenia will be measured in days in patients receiving R-TPR-029 / Neulasta® (Neulastim®)  
 
Secondary Outcome  
Outcome  TimePoints 
• Incidence of Grade 4 neutropenia .
• The incidence of febrile neutropenia.
• The duration of febrile neutropenia in Cycles 1 to 4.
• Time to ANC recovery in days after the ANC nadir.
• Depth of ANC nadir
• Evaluation of safety upto 6 months after the first dose of PEG-GCSF in the study
• Immunogenicity assessment
 
2nd, 3rd & 4th cycle of chemotherapy 
 
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)   10/10/2014 
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="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  

Neutropenia is the most serious hematologic toxicity of cancer chemotherapy, often limiting the doses of chemotherapy that can be tolerated. Chemotherapy predisposes patients with cancer to infections both by suppressing the production of neutrophils and by cytotoxic effects on the cells that line the alimentary tract. Neutrophils are the first line of defense against infection as the first cellular component of the inflammatory response and a key component of innate immunity. Neutropenic complications associated with myelosuppressive chemotherapy are a significant cause of morbidity and mortality, possibly compromised treatment outcomes, and excessive healthcare costs.

G-CSF is a glycoprotein which stimulates the survival, proliferation, differentiation and function of neutrophil granulocyte progenitor cells and mature neutrophils. The two forms of recombinant human G-CSF in clinical use (filgrastim and pegfilgrastim) are potent stimulants of neutrophil granulopoiesis and are indicated in reduction of duration and incidence of FN in patients treated with cytotoxic chemotherapy for malignancy. Pegfilgrastim is a sustained duration form of filgrastim, due to decreased renal clearance.

 

R-TPR-029 has been developed by RLS as a similar biological medicinal product (PEG-GCSF) to Neulasta® (Neulastim®) and is intended to be used in patients with chemotherapy-induced neutropenia. The proposed study will be conducted in compliance with the protocol, Good Clinical Practice (GCP) and applicable regulatory requirements

 
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