Trial record 3 of 154 for:    1401

Efficacy and Safety Study With MYL-1401H and Neulasta

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2015 by Mylan Inc.
Sponsor:
Collaborator:
Mylan GmbH
Information provided by (Responsible Party):
Mylan Inc.
ClinicalTrials.gov Identifier:
NCT02467868
First received: June 8, 2015
Last updated: July 28, 2015
Last verified: July 2015
  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
Endpoint Classification: Safety/Efficacy Study
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) ] [ Designated as safety issue: Yes ]

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

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

  • Presence of antibodies against MYL-1401H and Pegfilgrastim [ Time Frame: Week 24 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 189
Study Start Date: March 2015
Estimated Study Completion Date: March 2016
Estimated 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
Genders Eligible for Study:   Both
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

Contacts
Contact: Fausto Berti MYL-1401H-3001@mylan.com

Locations
Bulgaria
Mylan Investigational Site 3502 Recruiting
Plovdiv, Bulgaria
Mylan Investigational Site 3506 Recruiting
Plovdiv, Bulgaria
Mylan Investigational Site 3507 Recruiting
Plovdiv, Bulgaria
Mylan Investigational Site 3503 Recruiting
Sofia, Bulgaria
Mylan Investigational Site 3505 Recruiting
Sofia, Bulgaria
Mylan Investigational SIte 3501 Recruiting
Tarnovo, Bulgaria
Mylan Investigational Site 3504 Recruiting
Varna, Bulgaria
Georgia
Mylan Investigational Site 9905 Recruiting
Tbilisi, Georgia
Mylan Investigational Site 9902 Recruiting
Tbilisi, Georgia
Mylan Investigational Site 9903 Recruiting
Tbilisi, Georgia
Mylan Investigational Site 9904 Recruiting
Tbilisi, Georgia
Mylan Investigational Site 9901 Recruiting
Tbilisi, Georgia
Mylan Investigational Site 9906 Recruiting
Tbilisi, Georgia
Mylan Investigational Site 9907 Recruiting
Tbilisi, Georgia
Germany
Mylan Investigational site 4905 Recruiting
Bonn, Germany
Hungary
Mylan Investigational SIte 3606 Recruiting
Budapest, Hungary
Mylan Investigational Site 3607 Recruiting
Budapest, Hungary
Mylan Investigational Site 3604 Recruiting
Budapest, Hungary
Mylan Investigational Site 3609 Recruiting
Debrecen, Hungary
Mylan Investigational Site 3601 Recruiting
Gyula, Hungary
Mylan Investigational SIte 3605 Recruiting
Nyiregyhaza, Hungary
Mylan Investigational Site 3603 Recruiting
Szombathely, Hungary
Mylan Investigational Site 3602 Recruiting
Zalaegerszeg, Hungary
Poland
Mylan Investigational site 4802 Recruiting
Bydgoszcz, Poland
Mylan Investigational Site 4805 Recruiting
Koscierzyna, Poland
Mylan Investigational SIte 4804 Recruiting
Krakow, Poland
Ukraine
Mylan Investigational SIte 3804 Recruiting
Chernivtsi, Ukraine
Mylan Investigational site 3801 Recruiting
Dniepropetrovsk, Ukraine
Mylan Investigational Site 3805 Recruiting
Dniepropetrovsk, Ukraine
Mylan Investigational Site 3808 Recruiting
Kharkiv, Ukraine
Mylan Investigational Site 3810 Recruiting
Kyiv, Ukraine
Mylan Investigatational Site 3802 Recruiting
Lutsk, Ukraine
Mylan Investigational SIte 3807 Recruiting
Lviv, Ukraine
Mylan Investigational SIte 3803 Recruiting
Odesa, Ukraine
Mylan Investigational Site 3809 Recruiting
Sumy, Ukraine
Mylan Investigational Site 3806 Recruiting
Uzhgorod, Ukraine
Sponsors and Collaborators
Mylan Inc.
Mylan GmbH
Investigators
Study Chair: Rasmus Rojkjaer, MD Mylan GmbH
  More Information

No publications provided

Responsible Party: Mylan Inc.
ClinicalTrials.gov Identifier: NCT02467868     History of Changes
Other Study ID Numbers: MYL-1401H-3001, 2014-002324-27
Study First Received: June 8, 2015
Last Updated: July 28, 2015
Health Authority: Belarus: Ministry of Health
Bulgaria: Ministry of Health
Georgia: Ministry of Health
Germany: Federal Institute for Drugs and Medical Devices
Hungary: National Institute of Pharmacy
Mexico: Federal Commission for Protection Against Health Risks
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Russia: Ministry of Health of the Russian Federation
Ukraine: Ministry of Health

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

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

ClinicalTrials.gov processed this record on July 29, 2015