Efficacy and Safety Study With MYL-1401H and Neulasta

NCT ID: NCT02467868

Last Updated: 2022-02-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 193 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-03-31
• Study Completion Date: 2016-02-29

Brief Summary

This is a Multicenter, Double-Blind, Randomized, Comparative Efficacy and Safety Study of MYL-1401H and Neulasta (Pegfilgrastim) in Stage II/III Breast Cancer Patients Receiving Neoadjuvant or Adjuvant Chemotherapy.

Detailed Description

After successful screening, eligible patients will be randomly allocated to one of the two study arms, either receiving MYL-1401H or Neulasta.

Randomization is 2:1 to MYL-1401H or Neulasta, respectively.

Subjects will receive first of six cycles of background therapy (Docetaxel, Doxorubicin, Cyclophosphamide [TAC]) on day 1. Treatment with study drug (either MYL-1401H or Neulasta) is scheduled on Day 2 of each cycle, at least 24 hours after chemotherapy administration.

Duration of each cycle is 3 weeks.

Follow-up visit is scheduled 24 weeks after the first administration of study drug.

Conditions

Breast Neoplasms; Chemotherapy-Induced Febrile Neutropenia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

MYL-1401H

MYL-1401H

Group Type: EXPERIMENTAL

MYL-1401H

Intervention Type: BIOLOGICAL

During each chemotherapy cycle MYL-1401H (6 mg) is administered s.c. 24 hours after chemotherapy.

Neulasta

Neulasta

Group Type: ACTIVE_COMPARATOR

Neulasta

Intervention Type: BIOLOGICAL

During each chemotherapy cycle Neulasta (6 mg) is administered s.c. 24 hours after chemotherapy.

Interventions

MYL-1401H

During each chemotherapy cycle MYL-1401H (6 mg) is administered s.c. 24 hours after chemotherapy.

Intervention Type: BIOLOGICAL

Neulasta

During each chemotherapy cycle Neulasta (6 mg) is administered s.c. 24 hours after chemotherapy.

Intervention Type: BIOLOGICAL

Other Intervention Names

Pegfilgrastim; Recombinant human granulocyte colony-stimulating factor (G-CSF); Pegfilgrastim; Recombinant human granulocyte colony-stimulating factor (G-CSF)

Eligibility Criteria

Inclusion Criteria

• Signed and dated written informed consent.
• Patients ≥18 years.
• Women of child-bearing potential must agree to use effective methods of birth control during the treatment period from the first dose of study drug until 6 months following the last dose of study drug.
• Newly diagnosed, pathologically confirmed breast cancer.
• Stage II or III breast cancer with adequate staging workup and adequate surgery if receiving adjuvant therapy.
• Patients planned/eligible to receive neoadjuvant or adjuvant treatment with (Docetaxel, Doxorubicin, Cyclophosphamide [TAC]) for their breast cancer.
• Cancer Chemotherapy and Radiotherapy naïve.
• Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1
• Absolute neutrophil count ≥ 1.5 × 109/L ; Platelet count ≥ 100 × 109/L ;
• Hemoglobin > 10 g/dL without blood transfusions or cytokine support during the two weeks previous to the hemoglobin level.
• Adequate cardiac function (including left ventricular ejection fraction ≥ 50% as assessed by echocardiography) within 4 weeks prior to start of chemotherapy.
• Adequate renal function, i.e., creatinine < 1.5 × upper limit of normal (ULN).

Exclusion Criteria

• Participation in a clinical trial in which they received an investigational drug within 28 days before randomization.
• Previous exposure to filgrastim, pegfilgrastim, lenograstim, lipegfilgrastim, or other filgrastim forms on the market or in clinical development.
• Received blood transfusions or erythroid growth factors within 2 weeks prior to first dose of chemotherapy.
• Known hypersensitivity to any drugs or excipients that patients will be receiving during the study.
• Known hypersensitivity to E. coli-derived products.
• Known fructose intolerance (related with sorbitol excipient).
• Underlying neuropathy of grade 2 or higher.
• Active infectious disease or any other medical condition which might put the patient at significant risk to tolerate 6 courses of TAC chemotherapy (e.g., recent myocardial infarction).
• Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 2.5 × Upper limit of normal (ULN), ALT and/or AST > 1.5 × ULN with alkaline phosphatase (ALP) > 2.5 × ULN; any bilirubin > ULN.
• Treatment with systemically active antibiotics within 5 days before first dose of chemotherapy.
• Patients under treatment with lithium.
• Chronic use of oral corticosteroids.
• Splenomegaly of unknown origin by physical examination and/or computerized tomography scan or ultrasound and any condition which can cause splenomegaly, e.g., thalassemia, glandular fever, hemolytic anemias, and malaria.
• Myeloproliferative or myelodysplastic disorders, sickle cell disorders, and any illness or condition that in the opinion of the investigator may affect the safety of the patient or the evaluation of any study endpoint.
• Increase potential risk of Adult Respiratory Distress Syndrome.
• Pregnant or nursing women.
• Patients known to be seropositive for human immunodeficiency virus (HIV), or who have had an acquired immunodeficiency syndrome (AIDS) defining illness or a known immunodeficiency disorder.
• A known active abuse of drugs or alcohol should preclude patient participation and evaluation in the study.
• Any known psychiatric conditions.
• Any disease or physical condition that may not allow for the adequate performance of study assessments, such as lack of access to patient's domiciliary, and distance of patient's domiciliary from clinic site.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mylan GmbH

INDUSTRY

Sponsor Role: collaborator

Mylan Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Rasmus Rojkjaer, MD

Role: STUDY_CHAIR

Mylan GmbH

Locations

Mylan Investigational Site 3502

Plovdiv, , Bulgaria

Mylan Investigational Site 3506

Plovdiv, , Bulgaria

Mylan Investigational Site 3507

Plovdiv, , Bulgaria

Mylan Investigational Site 3503

Sofia, , Bulgaria

Mylan Investigational Site 3505

Sofia, , Bulgaria

Mylan Investigational Site 3504

Varna, , Bulgaria

Mylan Investigational SIte 3501

Veliko Tarnovo, , Bulgaria

Mylan Investigational Site 9901

Tbilisi, , Georgia

Mylan Investigational Site 9902

Tbilisi, , Georgia

Mylan Investigational Site 9903

Tbilisi, , Georgia

Mylan Investigational Site 9904

Tbilisi, , Georgia

Mylan Investigational Site 9905

Tbilisi, , Georgia

Mylan Investigational Site 9906

Tbilisi, , Georgia

Mylan Investigational Site 9907

Tbilisi, , Georgia

Mylan Investigational site 4905

Bonn, , Germany

Mylan Investigational Site 3604

Budapest, , Hungary

Mylan Investigational SIte 3606

Budapest, , Hungary

Mylan Investigational Site 3607

Budapest, , Hungary

Mylan Investigational Site 3609

Debrecen, , Hungary

Mylan Investigational Site 3601

Gyula, , Hungary

Mylan Investigational SIte 3605

Nyíregyháza, , Hungary

Mylan Investigational Site 3603

Szombathely, , Hungary

Mylan Investigational Site 3602

Zalaegerszeg, , Hungary

Mylan Investigational site 4802

Bydgoszcz, , Poland

Mylan Investigational Site 4805

Kościerzyna, , Poland

Mylan Investigational SIte 4804

Krakow, , Poland

Mylan Investigational SIte 3804

Chernivtsi, , Ukraine

Mylan Investigational site 3801

Dniepropetrovsk, , Ukraine

Mylan Investigational Site 3805

Dniepropetrovsk, , Ukraine

Mylan Investigational Site 3808

Kharkiv, , Ukraine

Mylan Investigational Site 3810

Kyiv, , Ukraine

Mylan Investigatational Site 3802

Lutsk, , Ukraine

Mylan Investigational SIte 3807

Lviv, , Ukraine

Mylan Investigational SIte 3803

Odesa, , Ukraine

Mylan Investigational Site 3809

Sumy, , Ukraine

Mylan Investigational Site 3806

Uzhhorod, , Ukraine

Countries

Bulgaria; Georgia; Germany; Hungary; Poland; Ukraine

References

Waller CF, Ranganna GM, Pennella EJ, Blakeley C, Bronchud MH, Mattano LA Jr, Berzoy O, Voitko N, Shparyk Y, Lytvyn I, Rusyn A, Popov V, Lang I, Beckmann K, Sharma R, Baczkowski M, Kothekar M, Barve A. Randomized phase 3 efficacy and safety trial of proposed pegfilgrastim biosimilar MYL-1401H in the prophylactic treatment of chemotherapy-induced neutropenia. Ann Hematol. 2019 May;98(5):1217-1224. doi: 10.1007/s00277-019-03639-5. Epub 2019 Mar 1.

Reference Type: DERIVED

PMID: 30824956 (View on PubMed)

Other Identifiers

2014-002324-27

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

MYL-1401H-3001

Identifier Type: -

Identifier Source: org_study_id