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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03511378
Recruitment Status : Completed
First Posted : April 27, 2018
Last Update Posted : October 8, 2019
Sponsor:
Information provided by (Responsible Party):
Lupin Ltd.

Study Description
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Brief 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

Condition or disease Intervention/treatment Phase
Breast Cancer Drug: Lupin's Pegfilgrastim Drug: Neulasta® Phase 4

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 138 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : March 6, 2018
Actual Primary Completion Date : January 9, 2019
Actual Study Completion Date : January 9, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arms and Interventions
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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 Name: 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 Name: Reference


Outcome Measures
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Primary Outcome Measures :
  1. Primary Immunogenicity Endpoint: Comparison of cumulative Incidence of anti-pegfilgrastim antibodies (binding & neutralizing) at the end of cycle 4 (Day 84) [ Time Frame: End of cycle 4, Day 84 ]
    The difference in the proportion of patients with cumulative incidence of anti-pegfilgrastim antibodies (binding & neutralizing) to Pegfilgrastim between study groups at the end of cycle 4 (Day 84) will be calculated. Those samples confirmed to be positive for binding antibodies will be analyzed for presence of neutralizing antibodies to Pegfilgrastim.


Secondary Outcome Measures :
  1. Secondary Immunogenicity endpoint: Comparison of cumulative incidence of anti-peg antibodies (binding & neutralizing) between treatment groups at the end of cycle 4 (Day 84) [ Time Frame: Day 84. ]
    Presence of anti-pegfilgrastim antibodies between treatment group at the end of cycle 4 (Day 84)

  2. Secondary Immunogenicity endpoint: 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: Day 10, 21, 42, 63, and Day 84 ]
    comparison of incidence of anti-peg antibodies (binding & neutralizing) to pegfilgrastim between treatment groups on Day 10, Day 21, Day 42, Day 63, Day 84

  3. 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) between treatment groups on Day 10, Day 21, Day 42, Day 63 and Day 84


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03511378


Locations
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Sponsors and Collaborators
Lupin Ltd.
Investigators
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Study Director: Dhananjay Bakhle, MD Lupin Limited
More Information
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Responsible Party: Lupin Ltd.
ClinicalTrials.gov Identifier: NCT03511378    
Other Study ID Numbers: LRP/PegGCSF/2016/004
First Posted: April 27, 2018    Key Record Dates
Last Update Posted: October 8, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Lupin Ltd.:
Breast Carcinoma
Breast neoplasms
Breast Tumors
 Cancer of Breast
Anti-Drug Antibodies (ADA)
Immunogenicity
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases