Immunogenicity Assessment of Peg-filgrastim vs. Neulasta® as Adjunct to Chemotherapy in Patients With Breast Cancer

Breast Cancer Clinical Trial

Official title:

An Open-label, Randomized, Comparative, Parallel Group Study to Assess the Immunogenicity of Lupin's Peg-filgrastim Versus Neulasta® as an Adjunct to Chemotherapy in Patients With Breast Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03511378
• Other study ID #: LRP/PegGCSF/2016/004
• Status: Completed
• Phase: Phase 4
• Start date: March 6, 2018
• Est. completion date: January 9, 2019

Study information

• Verified date: May 2021
• Source: Lupin Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to compare the immunogenicity of Peg-filgrastim versus Neulasta® as an adjunct to chemotherapy in patients with breast cancer

Description:

An open-label, randomized, comparative, parallel group study to assess the Immunogenicity of Lupin's Peg-filgrastim versus Neulasta® as an Adjunct to Chemotherapy in Patients with Breast Cancer Primary Objective: To assess the immunogenicity of Lupin's Peg-filgrastim with Neulasta® in patients with breast cancer. Secondary Objectives: To assess the safety of Lupin's Peg-filgrastim with Neulasta® in patients with breast cancer

Recruitment information / eligibility

• Status: Completed
• Enrollment: 138
• Est. completion date: January 9, 2019
• Est. primary completion date: January 9, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Patients must be able and willing to give written informed consent prior to any study related procedures

2. Ambulatory, female patients with an age = 18 years

3. Patients with histologically or cytologically proven diagnosis of breast cancer who are eligible for neoadjuvant or adjuvant chemotherapy.

4. Patients who are planned and eligible to receive/ receiving myelosuppressive chemotherapy regimen that contains at least one chemotherapeutic agent from docetaxel/ paclitaxel / doxorubicin/ cyclophosphamide/ epirubicin

5. Patients who have not received any hematopoietic growth factors (e.g. G-CSF, PegGCSF, erythropoietin) or cytokines (e.g. interleukins, interferons) anytime in the past

6. Patients with baseline WBC = LLN/ 3.5 x 109/L, ANC of = 1.5 x 109/L, platelet count = 100 x 109/L and hemoglobin = 8.5 g/dL

7. Patients with ECOG Performance status of = 2

8. Patient who have estimated life expectancy of more than six months

9. No evidences of hemorrhage Exclusion Criteria: 1 Male patients

2. Hypersensitivity to any of the study drugs or its components like E.coli proteins or similar product

3. Patients weighing <45 Kg

4. Patients with myeloid malignancies and myelodysplasia or evidence of metastatic disease in bone marrow or brain

5. Patients currently receiving radiation therapy or have completed radiation therapy within 4 weeks before study entry or likely to receive radiotherapy during the study

6. Patients with prior bone marrow or stem cell transplantation

7. Patients with chronic use of oral corticosteroids (Except = 20 mg/day dose of prednisolone/ equivalent steroids), immunotherapy, monoclonal antibody therapy and/or biological therapy or use of any other pegylated drug.

8. Patients with history of systemic antibiotic use within 72 hours prior to chemotherapy

9. Patients with any active infection which may require systemic antimicrobial therapy. Patients with inadequate hepatic and renal function [defined as Alkaline Phosphatase > 2.5 X Upper limits of normal (ULN), serum SGOT > 2.5 X ULN, SGPT > 2.5 X ULN, Total bilirubin > 1.5 X ULN and Creatinine > 1.5 X ULN of the reference range at the screening assessment]

10. Patients with seropositivity for HIV or HBV or HCV

11. Known cases of Sickle Cell Anemia

12. Patients with radiographic evidence of active pulmonary infections and/or recent history of pneumonia within 1 month of screening

13. Patients with clinically evident splenomegaly confirmed subsequently by ultrasonography

14. Patients with any other clinically significant disease(s) which, in the opinion of the investigator, could compromise the patient's involvement in the study or overall interpretation of the data. [for e.g. uncontrolled hematologic, renal, hepatic, endocrine, neurologic, psychiatric, metabolic, pulmonary, cardiovascular disease/impaired functioning or history of any autoimmune disease]

15. Patients who have participated in another therapeutic clinical study within the past 30 days prior to screening, or are likely to simultaneously participate in another therapeutic clinical study

16. Patients who are doubtful to comply with study procedures for mental, psychological or social reasons.

17. Women of child-bearing potential who are not willing to follow a reliable & effective contraceptive measure during the course of the study & at least 3 months after the last dose of study drug.

18. Pregnant and Breast feeding women.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• Lupin's Pegfilgrastim
Administration of Pegfilgrastim
• Neulasta®
Administration of Neulasta®

Locations

Country	Name	City	State
India	Research & Development Department, HCG Cancer Center	Ahmedabad	Gujarat
India	Clinical Research Department	Bande	Nagpur
India	Sri Venketeshwara Hospital, Dept of Medical oncology	Bengaluru	Karnataka
India	Acharya Tulsi Regional Cancer Treatment & Research Institute	Bikaner	Rajahstan
India	M S Patel Cancer Centre,	Gokal	Anand
India	Adhar health Institute	Hisar	Haryana
India	Global Clinical Research Services Pvt Ltd.	Hyderabad	Telangana
India	Apollo Gleneagles Hospitals	Kolkata	West Bengal
India	Curie Manavata Cancer Centre	Mumbai	Maharashtra
India	Government Medical College & Hospital	Nagpur	Maharashtra
India	Sterling Hospital	Nigdi	Maharashtra
India	Apple Hospital	Surat	Gujarat
India	Nirmal Hospital	Surat	Gujarat
India	Bhaktivedanta Hospital & Research Institute	Thane	Maharashtra
India	Kailash Cancer Hospital & Research Center	Vadodara	Gujarat
India	Shree Himalaya Cancer Hospital & Research Institute,	Vadodara	Gujarat
India	City Cancer Center	Vijayawada	Andhra Pradesh

Sponsors (1)

Lead Sponsor	Collaborator
Lupin Ltd.

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comparison of Cumulative Incidence of Anti-pegfilgrastim Antibodies (Binding and Neutralizing) to Pegfilgrastim Between Treatment Groups at the End of Cycle 4 (Day 84).	The difference in cumulative incidence of anti-pegfilgrastim antibodies (binding and neutralizing) (measured as difference in proportion of patients with antibodies) to Pegfilgrastim between study groups at the end of cycle 4 will be calculated. Those samples confirmed to be positive for binding antibodies were analyzed for presence of neutralizing antibodies to Pegfilgrastim.	End of cycle 4, Day 84
Secondary	Comparison of Cumulative Incidence of Anti-peg Antibodies (Binding and Neutralizing) Between Treatment Groups at the End of Cycle 4 (Day 84).	The presence of anti-peg antibodies (binding) (measured as difference in proportion of patients with antibodies) between treatment groups at the end of cycle 4 (Day 84) were compared and analysis for the ITT population	Day 84.
Secondary	Comparison of Incidence of Anti-pegfilgrastim Antibodies (Binding & Neutralizing) to Pegfilgrastim Between Treatment Groups on Day 10, Day 21, Day 42, Day 63 and Day 84	Comparison of incidence of anti-pegfilgrastim antibodies (binding & neutralizing) (measured as difference in proportion of patients with antibodies) to pegfilgrastim between treatment groups on Day 10, Day 21, Day 42, Day 63, Day 84. Analysis population : ITT	Assessment at each study visit on Day 10, Day 21, Day 42, Day 63, Day 84
Secondary	Secondary Immunogenicity Endpoint	Comparison of incidence of anti-peg antibodies (binding & neutralizing) (measured as difference in proportion of patients with antibodies) between treatment groups on Day 10, Day 21, Day 42, Day 63 and Day 84. Analysis population: ITT population	Day 10, Day 21, Day 42, Day 63 and Day 84.