| 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 |
|
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Secondary IDs if Any
|
| Secondary ID |
Identifier |
| RLS/TP/2011/01, Version 5, dated 24th Mar 2014 |
Protocol Number |
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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 |
|
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Details of Secondary Sponsor
|
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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 |
|
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Regulatory Clearance Status from DCGI
|
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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.
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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 |
|
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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 |
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Publication Details
|
|
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
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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 |