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

May 19, 2021 updated by: Lupin Ltd.

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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

Study Type

Interventional

Enrollment (Actual)

138

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
    • Anand
      • Gokal, Anand, India, 388325
        • M S Patel Cancer Centre,
    • Andhra Pradesh
      • Vijayawada, Andhra Pradesh, India, 520002
        • City Cancer Center
    • Gujarat
      • Ahmedabad, Gujarat, India, 380006
        • Research & Development Department, HCG Cancer Center
      • Sūrat, Gujarat, India, 395002
        • Apple Hospital
      • Sūrat, Gujarat, India, 395002
        • Nirmal Hospital
      • Vadodara, Gujarat, India, 390007
        • Shree Himalaya Cancer Hospital & Research Institute,
      • Vadodara, Gujarat, India, 391760
        • Kailash Cancer Hospital & Research Center
    • Haryana
      • Hisar, Haryana, India, 125001
        • Adhar health Institute
    • Karnataka
      • Bengaluru, Karnataka, India, 560068
        • Sri Venketeshwara Hospital, Dept of Medical oncology
    • Maharashtra
      • Mumbai, Maharashtra, India, Nasik- 422004
        • Curie Manavata Cancer Centre
      • Nagpur, Maharashtra, India, 440009
        • Government Medical College & Hospital
      • Nigdi, Maharashtra, India, 411044
        • Sterling Hospital
      • Thāne, Maharashtra, India, 401107
        • Bhaktivedanta Hospital & Research Institute
    • Nagpur
      • Bande, Nagpur, India, 44026
        • Clinical Research Department
    • Rajahstan
      • Bīkaner, Rajahstan, India, 334003
        • Acharya Tulsi Regional Cancer Treatment & Research Institute
    • Telangana
      • Hyderabad, Telangana, India, 500004
        • Global Clinical Research Services Pvt Ltd.
    • West Bengal
      • Kolkata, West Bengal, India, 7000054
        • Apollo Gleneagles Hospitals

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Lupin's Pegfilgrastim
6 mg, subcutaneous injection on day 2/3 of each 21 ± 3 day cycle. Number of cycles: 4.
Drug: Lupin's Pegfilgrastim
Administration of Pegfilgrastim
Other Names:
  • INvestigational product
Experimental: Neulasta®
6 mg, subcutaneous injection on day 2/3 of each 21 ± 3 day cycle. Number of cycles: 4.
Drug: Neulasta®
Administration of Neulasta®
Other Names:
  • Reference

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comparison of Cumulative Incidence of Anti-pegfilgrastim Antibodies (Binding and Neutralizing) to Pegfilgrastim Between Treatment Groups at the End of Cycle 4 (Day 84).
Time Frame: 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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comparison of Cumulative Incidence of Anti-peg Antibodies (Binding and Neutralizing) Between Treatment Groups at the End of Cycle 4 (Day 84).
Time Frame: 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.
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
Time Frame: Assessment at each study visit on Day 10, Day 21, Day 42, Day 63, 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 Immunogenicity Endpoint
Time Frame: Day 10, Day 21, Day 42, Day 63 and Day 84.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lupin Ltd.

Investigators

  • Study Director: Dhananjay Bakhle, MD, Lupin Limited

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 6, 2018

Primary Completion (Actual)

January 9, 2019

Study Completion (Actual)

January 9, 2019

Study Registration Dates

First Submitted

March 20, 2018

First Submitted That Met QC Criteria

April 18, 2018

First Posted (Actual)

April 27, 2018

Study Record Updates

Last Update Posted (Actual)

June 15, 2021

Last Update Submitted That Met QC Criteria

May 19, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LRP/PegGCSF/2016/004

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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