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Trial record 3 of 197 for:    1401

Efficacy and Safety Study With MYL-1401H and Neulasta

This study has been completed.
Sponsor:
Collaborator:
Mylan GmbH
Information provided by (Responsible Party):
Mylan Inc.
ClinicalTrials.gov Identifier:
NCT02467868
First received: June 8, 2015
Last updated: March 15, 2016
Last verified: March 2016
  Purpose
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.

Condition Intervention Phase
Breast Neoplasms
Chemotherapy-Induced Febrile Neutropenia
Biological: MYL-1401H
Biological: Neulasta
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Multicenter, Double-Blind, Randomized, Comparative Efficacy and Safety Study of MYL-1401H and European Sourced Neulasta® in Stage II/III Breast Cancer Patients Receiving Neoadjuvant or Adjuvant Chemotherapy

Resource links provided by NLM:


Further study details as provided by Mylan Inc.:

Primary Outcome Measures:
  • Mean Duration of Severe Neutropenia (DSN), defined as consecutive days with absolute neutrophil count (ANC) < 0.5 × 109/L [ Time Frame: Cycle 1 of chemotherapy (approx 21 days) ]

Secondary Outcome Measures:
  • The rate of febrile neutropenia (FN) [ Time Frame: Week 24 (End of the study) ]

Other Outcome Measures:
  • Incidence, nature, and severity of adverse events (AEs) [ Time Frame: Week 24 ]
    Rate of FN listed by cycles and across cycles

  • Presence of antibodies against MYL-1401H and Pegfilgrastim [ Time Frame: Week 24 ]

Enrollment: 193
Study Start Date: March 2015
Study Completion Date: February 2016
Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: MYL-1401H
MYL-1401H
Biological: MYL-1401H
During each chemotherapy cycle MYL-1401H (6 mg) is administered s.c. 24 hours after chemotherapy.
Other Names:
  • Pegfilgrastim
  • Recombinant human granulocyte colony-stimulating factor (G-CSF)
Active Comparator: Neulasta
Neulasta
Biological: Neulasta
During each chemotherapy cycle Neulasta (6 mg) is administered s.c. 24 hours after chemotherapy.
Other Names:
  • Pegfilgrastim
  • Recombinant human granulocyte colony-stimulating factor (G-CSF)

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.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).

Other protocol specific inclusion/exclusion criteria may apply

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02467868

Locations
Bulgaria
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 3501
Tarnovo, Bulgaria
Mylan Investigational Site 3504
Varna, Bulgaria
Georgia
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
Germany
Mylan Investigational site 4905
Bonn, Germany
Hungary
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
Nyiregyhaza, Hungary
Mylan Investigational Site 3603
Szombathely, Hungary
Mylan Investigational Site 3602
Zalaegerszeg, Hungary
Poland
Mylan Investigational site 4802
Bydgoszcz, Poland
Mylan Investigational Site 4805
Koscierzyna, Poland
Mylan Investigational SIte 4804
Krakow, Poland
Ukraine
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
Uzhgorod, Ukraine
Sponsors and Collaborators
Mylan Inc.
Mylan GmbH
Investigators
Study Chair: Rasmus Rojkjaer, MD Mylan GmbH
  More Information

Responsible Party: Mylan Inc.
ClinicalTrials.gov Identifier: NCT02467868     History of Changes
Other Study ID Numbers: MYL-1401H-3001
2014-002324-27 ( EudraCT Number )
Study First Received: June 8, 2015
Last Updated: March 15, 2016

Keywords provided by Mylan Inc.:
Pegfilgrastim
Granulocyte Colony Stimulating Factor (G-CSF)
Breast Cancer
Neutropenia

Additional relevant MeSH terms:
Breast Neoplasms
Neutropenia
Febrile Neutropenia
Chemotherapy-Induced Febrile Neutropenia
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Agranulocytosis
Leukopenia
Leukocyte Disorders
Hematologic Diseases
Lenograstim
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on March 23, 2017