Comparing the Safety and Efficacy of USV Pegfilgrastim and Neulasta® in Breast Cancer Patients

• Register: CTRI
• Last refreshed on: 24 November 2021
• Main ID: CTRI/2014/09/005007
• Date of registration: 11-09-2014
• Prospective Registration: Yes
• Primary sponsor: USV Private Limited
• Public title: Comparing the Safety and Efficacy of USV Pegfilgrastim and Neulasta® in Breast Cancer Patients
• Scientific title: 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
• Date of first enrolment: 16-11-2016
• Target sample size: 120
• Recruitment status: Closed to Recruitment of Participants
• URL: http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=9303
• Study type: Interventional
• Study design: Randomized, Parallel Group, Active Controlled Trial; Method of generating randomization sequence:Permuted block randomization, fixed Method of allocation concealment:Sequentially numbered, sealed, opaque envelopes Blinding and masking:Open Label
• Phase: Phase 3

Countries of recruitment

India

Contacts

• Name: Dr Vasant V Joshi
• Affiliation: USV Private Limited

• Name: Dr Vasant V Joshi
• Affiliation: USV Private Limited

Key inclusion & exclusion criteria

Inclusion criteria: 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 Gilbertâ??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.


Exclusion criteria: 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



Age minimum:
Age maximum:
Gender:

Health Condition(s) or Problem(s) studied

Health Condition 1: null- Chemotherapy-induced neutropenia in breast cancer

Intervention(s)

Intervention1: USV PEG-Filgrastim: USV PEG-Filgrastim for 4 cycles of chemotherapy 3 weeks apart.
Control Intervention1: Neulasta: Neulasta for 4 cycles of chemotherapy 3 weeks apart.

Primary Outcome(s)

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).Timepoint: 2 weeks

Secondary Outcome(s)

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.Timepoint: 25 weeks

Secondary ID(s)

PEGF/USV/P3/001 (Version 3.1; Dated: 16 Mar 2016

Source(s) of Monetary Support

USV Private Limited; Arvind Vithal Gandhi Chowk, B.S.D. Marg, Govandi, Mumbai-400088. Maharashtra. India.

Secondary Sponsor(s)

Ecron Acunova Limited Formerly known as Manipal Acunova Limited

Ethics review

Status: Approved
Approval date: 16/05/2016
Contact:

Institutional Ethics Committee Karnataka Cancer Hospital

Status: Approved
Approval date: 17/05/2016
Contact:

Institutional Ethics Committee Curie Manavata Cancer Centre

Status: Approved
Approval date: 06/07/2016
Contact:

Central India Cancer Research Institute Ethics Committee

Status: Approved
Approval date: 13/08/2016
Contact:

Institutional Ethics Committee City Cancer Centre

Status: Approved
Approval date: 30/01/2017
Contact:

Institutional Ethics Committee of B. J. Govt. Medical College and Sassoon General Hospital

Status: Approved
Approval date: 28/02/2017
Contact:

Institutional Ethics Committee Government Medical College Nagpur

Status: Approved
Approval date: 25/03/2017
Contact:

Institutional Ethics Committee Meenakshi Mission Hospital and Research Centre

Status: Approved
Approval date: 12/04/2017
Contact:

Institutional Ethics Committee, Shri Ramchandra University