Efficacy and Safety Study With MYL-1401H and Neulasta
Information source: Mylan Inc.
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Breast Neoplasms; Chemotherapy-Induced Febrile Neutropenia
Intervention: MYL-1401H (Biological); Neulasta (Biological)
Phase: Phase 3
Status: Active, not recruiting
Sponsored by: Mylan Inc. Official(s) and/or principal investigator(s): Rasmus Rojkjaer, MD, Study Chair, Affiliation: Mylan GmbH
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.
Clinical Details
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
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Mean Duration of Severe Neutropenia (DSN), defined as consecutive days with absolute neutrophil count (ANC) < 0.5 × 109/L
Secondary outcome: The rate of febrile neutropenia (FN)
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
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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.
Locations and Contacts
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
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, Nyiregyhaza, Hungary
Mylan Investigational Site 3603, Szombathely, Hungary
Mylan Investigational Site 3602, Zalaegerszeg, Hungary
Mylan Investigational site 4802, Bydgoszcz, Poland
Mylan Investigational Site 4805, Koscierzyna, 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, Uzhgorod, Ukraine
Additional Information
Starting date: March 2015
Last updated: August 7, 2015
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