FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2014/09/005007 [Registered on: 11/09/2014] Trial Registered Prospectively
Last Modified On: 17/07/2018
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study
Modification(s)  		 Comparing the Safety and Efficacy of USV Pegfilgrastim and Neulasta® in Breast Cancer Patients 
Scientific Title of Study
Modification(s)  		 A Phase III, Randomized, Multicentric, Open-label, Equivalence Design Study to Compare the Safety and Efficacy of USV Pegfilgrastim and Neulasta ® in Patients Receiving Doxorubicin and Docetaxel as a Combination Chemotherapy for Breast Cancer 
Trial Acronym   
Secondary IDs if Any
Modification(s)  
Secondary ID  Identifier 
PEGF/USV/P3/001 (Version 3.1; Dated: 16 Mar 2016  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)  
Name  Dr Vasant V Joshi  
Designation  General Manager; USV Private Limited 
Affiliation  USV PrivateLimited 
Address  USV Private Limited, Arvind Vithal Gandhi Chowk, B.S.D. Marg, Govandi Mumbai

Mumbai
MAHARASHTRA
400088
India 
Phone  912225564048  
Fax    
Email  vasant.joshi@usv.in  
 
Details of Contact Person
Scientific Query
Modification(s)  
Name  Dr Vasant V Joshi  
Designation  General Manager; USV Private Limited 
Affiliation  USV Private Limited 
Address  USV Private Limited, Arvind Vithal Gandhi Chowk, B.S.D. Marg, Govandi Mumbai

Mumbai
MAHARASHTRA
400088
India 
Phone  912225564048  
Fax    
Email  vasant.joshi@usv.in  
 
Details of Contact Person
Public Query
Modification(s)  
Name  Dr Vasant V Joshi  
Designation  General Manager; USV Private Limited 
Affiliation  USV Private Limited 
Address  USV Private Limited, Arvind Vithal Gandhi Chowk, B.S.D. Marg, Govandi Mumbai

Mumbai
MAHARASHTRA
400088
India 
Phone  912225564048  
Fax    
Email  vasant.joshi@usv.in  
 
Source of Monetary or Material Support
Modification(s)  
USV Private Limited; Arvind Vithal Gandhi Chowk, B.S.D. Marg, Govandi, Mumbai-400088. Maharashtra. India. 
 
Primary Sponsor
Modification(s)  
Name  USV Private Limited 
Address  USV Private Limited Arvind Vithal Gandhi Chowk B.S.D. Marg Govandi Mumbai 400088. Maharashtra. India 
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor
Modification(s)  
Name  Address 
Ecron Acunova Limited Formerly known as Manipal Acunova Limited  Ecron Acunova Limited (Formerly known as Manipal Acunova Limited), Mobius Towers, SJR-i Park, EPIP, Whirefield, Bangalore - 560066, India 
 
Countries of Recruitment     India  
Sites of Study
Modification(s)  
No of Sites = 8  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Jadhav Kiran Kumar   B. J. Govt. Medical College and Sassoon General Hospital  1st Floor, surgery Department, Block # 10, Pune Station, Pune – 411001
Pune
MAHARASHTRA 		 8983107050

drkpjadhav@gmail.com 
Dr Ajay Mehta  Central India Cancer Research Institute   Ground Floor, 11, Shankar Nagar, West High Court Road, Nagpur-440010
Nagpur
MAHARASHTRA 		 91-9823190192

ajayonco@hotmail.com 
Dr V Siva Nageswara Rao  City Cancer Centre   33-25-22, 14, Venkata Krishnagar street, Suryaraopet, Vijayawada – 520002, A.P, India.
Krishna
ANDHRA PRADESH 		 919849121050

vsnrao@yahoo.co.uk 
Dr Sirshendu Ray  Curie Manavata Cancer Centre  Ground Floor OPD, Opposite Mahamarg Bus Stand, Mumbai Naka, Nashik - 422004
Nashik
MAHARASHTRA 		 91-9831122093

sirshendu_roy_ms@yahoo.com 
Dr Brajesh B Gupta  Govt. Medical College and Hospital, Nagpur  Dept. of General Surgery, Ward No 10, Govt. Medical College and Hospital, Nagpur-440003
Nagpur
MAHARASHTRA 		 9422147098

brajeshbgupta@gmail.com 
Jyothi Narayana  Karnataka Cancer Hospital & Research Centre  Karnataka Cancer Hospital & Research Centre, No. 99, Jharakabande Kaval, Nandini Layout Post, Krishnananda Nagar, Bangalore - 560022
Bangalore
KARNATAKA 		 91-09448051964

jyothichinnali@yahoo.com 
Dr Ananda Selvakumar Pandy  Meenakshi Mission Hospital and Research Centre  Lake Area, Melur Road, Madurai 625107,
Madurai
TAMIL NADU 		 9894333759

drask81@yahoo.co.in 
Dr Manickavasagam M  Shri Ramchandra Medical Centre  Main building, 1 floor, E1 oncology Department, No. 1, Ramachandra Nagar, Porur, Chennai - 600116
Chennai
TAMIL NADU 		 9842331012

manicks18@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 8  
Name of Committee  Approval Status 
Central India Cancer Research Institute Ethics Committee  Approved 
Institutional Ethics Committee Meenakshi Mission Hospital and Research Centre  Approved 
Institutional Ethics Committee City Cancer Centre  Approved 
Institutional Ethics Committee Curie Manavata Cancer Centre  Approved 
Institutional Ethics Committee Government Medical College Nagpur  Approved 
Institutional Ethics Committee Karnataka Cancer Hospital  Approved 
Institutional Ethics Committee of B. J. Govt. Medical College and Sassoon General Hospital  Approved 
Institutional Ethics Committee, Shri Ramchandra University  Approved 
 
Regulatory Clearance Status from DCGI
Modification(s)  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Chemotherapy-induced neutropenia in breast cancer,  
 
Intervention / Comparator Agent
Modification(s)  
Type  Name  Details 
Comparator Agent  Neulasta  Neulasta for 4 cycles of chemotherapy 3 weeks apart. 
Intervention  USV PEG-Filgrastim  USV PEG-Filgrastim for 4 cycles of chemotherapy 3 weeks apart. 
 
Inclusion Criteria
Modification(s)  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Female 
Details  1. Female ≥18 and ≤65 years of age;
2. Patient who has provided written informed consent;
3. Chemotherapy naive patient with documented high risk stage II, or stage III or stage IV breast cancer (classification according to American Joint Committee on Cancer-AJCC;
4. Patient scheduled to receive chemotherapy comprising of docetaxel (75 mg/m2) and doxorubicin (60mg/m2) for their breast cancer disease;
5. Estimated life expectancy more than 6 months;
6. ECOG Performance [Appendix 5] Status ≤ 2 as determined within 7 days prior to Day 1 of Cycle 1 of chemotherapy;
7. Adequate bone marrow function, as determined within 7 days prior to administration of chemotherapy on Day 1 of Cycle 1 and as indicated by:
• Hb ≥9 g/dL (transfusion permitted during study);
• ANC ≥1.5 x 109/L (≥1500/mm³);
• Platelet count ≥100,000/μL (≥100 x 109/L).
8. Adequate renal and hepatic function, as determined within 7 days prior to administration of chemotherapy on Day 1 of Cycle 1 and as indicated by:
• Creatinine <1.5 x Upper Limit of Normal (ULN);
• Total bilirubin within normal reference range (unless elevation is known to be due to Gilbert’s disease);

Patients must also meet one of the following criteria:
• Alkaline phosphatise (ALP) within normal reference range and both aspartate aminotransferase (AST) and alanine aminotransferase (ALT) <1.5 x ULN or
• Alkaline phosphatase <2.5 x ULN and both AST and ALT<1.5 x ULN or
• Alkaline phosphatase <5 x ULN and both AST and ALT within normal reference range.
 
 
ExclusionCriteria 
Details  1. Previous therapy with any Granulocyte-Colony Stimulating Factor (G-CSF) and Pegfilgrastim preparation;
2. Patients with history of severe chronic neutropenia (congenital, cyclic or
idiopathic);
3. Patients with history of chronic myeloid leukaemia or myelodysplastic syndrome;
4. Previous or concurrent malignancy except non-invasive non-melanomatous skin cancer, in-situ carcinoma of cervix, or other solid tumour treated curatively and without evidence of recurrence for at least 2 years prior to study entry;
5. Patient who require concurrent radiotherapy or have radiotherapy within the 4 weeks prior to the first dose of chemotherapy, except for localized spot radiotherapy for bone metastases (Day 1 of Cycle 1)
6. Patient who is having concurrent anti-cancer therapy, including endocrine therapy (with the exception of corticosteroids at doses ≤20 mg/day prednisolone or equivalent), immunotherapy, monoclonal antibody therapy and/or biological therapy;
7. Patient with chronic use of oral corticosteroids;
8. Concurrent treatment with bisphosphonates (unless the patient has been on a stable dose for four weeks prior to the first dose of chemotherapy [Day 1 of Cycle 1]);
9. Underlying neuropathy of grade 2 or higher;
10. Concurrent treatment with lithium;
11. Patients with prior bone marrow or stem cell transplantation;
12. Patients with leukocyte count more than 50 x 109/L;
13. Patients with cough, fever, dyspnoea in association with radiologic signs of pulmonary infiltrates at study entry;
14. Patient with clinically significant cardiac dysfunction at the time of screening, clinically significant findings on echocardiogram ( Ejection Fraction [EF] less than 50%) or a history of myocardial infarction or heart failure within 6 months preceding the first treatment cycle;
15. Brain metastases that are clinically symptomatic or being treated with steroids;
16. Patient with known hypersensitivity to E. Coli proteins or any of the excipients used in the test products;
17. Patients with rare hereditary problems of fructose intolerance, sickle cell disorders
18. Patients with positive serology for HIV1/2, Hepatitis B virus and/or Hepatitis C virus;
19. Pregnant or breast feeding women. Women of childbearing potential must have a negative urine pregnancy test within 7 days prior to Screening
20. Patient of childbearing potential unwilling to use a barrier method of contraception. It is required that a barrier method of contraception be used (i.e. condom with spermicide or diaphragm with spermicide) by patients (or their partners) of childbearing potential regardless of whether a hormonal agent also is used as a method of contraception
21. Patient with known active drug addiction, including alcoholism;
22. Patient with systemic disease that may interfere with safety, compliance, response to the product under investigation or its evaluation;
23. Patient with co-existing active infection or have received systemic anti-infectives for the treatment of infection within 72 hours prior to the first dose of chemotherapy (Day 1 of Cycle 1);
24. Patient with symptomatic anaemia
 
 
Method of Generating Random Sequence   Permuted block randomization, fixed 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Duration of severe neutropenia (DSN) during first chemotherapy cycle, defined as the number of days with grade 4 neutropenia with an ANC 0.5x109/L (500/mm3).  2 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
Duration of DSN in each of chemotherapy cycles 2-4. ANC nadir during each chemotherapy cycle. Incidence of febrile neutropenia by clycle and acroos all cycles. Time to recovery of ANC from the second and subsequent chemotherapy cycles. Incidence of IV antibiotic administration and hospitalization due to febrile neutropenia. All cause mortality after start of study drug therapy. Incidence of documented infections and length of stay in ICU. Number of blood transfusion required.  25 weeks 
 
Target Sample Size   Total Sample Size="120"
Sample Size from India="120" 
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)  		 16/11/2016 
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="2"
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)  

Phase III, randomized, multicentric, open-label, equivalence study, adult females diagnosed with breast cancer scheduled to undergo chemotherapy with doxorubicin and docetaxel will be enrolled. A total of 120 consenting patients who fulfil the eligibility criteria will be included into the study from 9 centres across India. Subjects will be randomized in 1:1 ratio to one of the two study treatment groups, stated below on Day 1 of the first chemotherapy cycle.

 

 

• Group I: USV PEG-Filgrastim (Test product) - 6 mg subcutaneous (SC) injection

• Group II: Neulasta® (Reference product) - 6 mg subcutaneous (SC) injection

Study drug will be administered by subcutaneous injection on Day 2 at least 24 hours after administration of chemotherapy.

 

All subjects will be provided information about the study and informed consent will be obtained before any screening procedure and enrolment into the study. There will be audio-video recording of consent process. Subjects will be enrolled in this study if they fulfil the eligibility criteria.

Chemotherapy will be repeated every 3-4 weeks and study evaluations for efficacy in this study will be for up to four cycles only. Subjects will be asked to visit the site 28 days after study drug administration for the 4th chemotherapy cycle or last chemotherapy cycle. In addition, there will be follow-up visits at the end of 3 months and 6 months (90 +/- 7 and 180 +/- 7 days, respectively, from the first dose of study drug) for the collection of blood sample for ANC only on 180 day visit and immunogenicity assessment on both of these visits.

 

Subjects completing the first cycle of chemotherapy will be evaluated for primary endpoint. Secondary endpoints will be evaluated as per the number of subjects completing each cycle

 

 
Close