Duration of Sever Neutropenia and incidence of febrile neutropenia MedDRA version: 18.0 Level: PT Classification code 10029354 Term: Neutropenia System Organ Class: 10005329 - Blood and lymphatic system disorders MedDRA version: 18.0 Level: PT Classification code 10016288 Term: Febrile neutropenia System Organ Class: 10005329 - Blood and lymphatic system disorders
Conditions
Interventions
Product Name: USV Pegfilgrastim
Product Code: USV Pegfilgrastim
Pharmaceutical Form: Solution for injection in pre-filled syringe
INN or Proposed INN: PEGFILGRASTIM
CAS Number: 208265-92-3
Current Spo
Sponsors
USV Limited
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Written and informed consent before any study procedure is started; 2. Women = 18 years of age; 3. Body weight within 40 and 120 kg; 4. Chemotherapy-naïve subjects with histologically proven breast cancer (Stage IIA, IIB, or IIIA) eligible for six chemotherapy cycles with TAC regimen as an adjuvant treatment; 5. Subjects within 60 days of complete surgical resection of the primary breast tumour: either lumpectomy or mastectomy with sentinel lymph node biopsy or axillary dissection, with clear margins for both invasive and ductal carcinoma in situ (DCIS); 6. Baseline bilateral mammography or other scan to exclude cancer on the contralateral breast; 7. Estimated life expectancy of more than six months; 8. Eastern cooperative oncology group (ECOG) performance status = 2; 9. Normal cardiac function evidenced by a left ventricle ejection fraction (LVEF) >=50% on echocardiogram performed within 60 days from surgery; 10. Adequate bone marrow function prior to chemotherapy administration as indicated by: a. Leukocyte count =65 years) yes F.1.3.1 Number of subjects for this age range 35
Exclusion criteria
Exclusion criteria: 1. Subjects with distant metastasis; 2. Subjects with severe chronic neutropenia (congenital, cyclic, or idiopathic); 3. History of chronic myeloid leukaemia or myelodysplastic syndrome; 4. History of sickle cell disease; 5. Subjects with active infections (including positive serology for human immunodeficiency virus [HIV] and active hepatitis B and C infection). Subjects with infections bacterial or fungal not controlled by antibiotic therapy; or history of uncontrolled seizures, or diabetes, or central nervous system disorders should be excluded as per the clinical judgement of the investigator precluding informed consent; 6. Previous or concurrent malignancy except non-invasive skin cancer (excluding melanoma), in situ carcinoma of the cervix, or other solid tumour treated with curative intent with no recurrence within two years prior to study entry; 7. Hormonal therapy (e.g. tamoxifen or aromatase inhibitors), immunotherapy and monoclonal antibodies or biological therapy concurrent or within 30 days of screening; 8. Significant neurologic or psychiatric disorders that would prohibit the understanding and giving of the informed consent; 9. Previous therapy with any recombinant human granulocyte colony stimulating factor (rhG-CSF) product, Lipegfilgrastim, or Pegfilgrastim preparation; 10. Concurrent radiotherapy; 11. Clinically significant cardiac dysfunction at the time of screening, history of myocardial infarction, heart failure, uncontrolled hypertension, severe valvular heart disease, unstable angina pectoris, pericardial disease, electrocardiographic evidence of acute ischemic changes or unstable arrhythmia within six months preceding the first treatment cycle; 12. History of pulmonary infiltrates or pneumonia within two years of study entry; 13. Known hypersensitivity to any of the chemotherapy drugs used in TAC regime or Escherichia coli (E. coli) proteins or any of the excipients used in the IMP; 14. Major organ allograft or condition requiring chronic immunosuppression (i.e. kidney, liver, lung, heart, bone marrow transplant, or autoimmune diseases). Subjects who received corneal transplants or cadaver skin or bone transplants are eligible; 15. Peripheral neuropathy >Grade 1; 16. Ongoing drug abuse and/or alcohol addiction and/or chronic alcoholism; 17. Participation in any other clinical study using an IMP within three months prior to the screening visit; 18. Pregnancy or breast feeding; 19. Any condition that by consideration of the investigators might affect the safety of the subject or interfere with the efficacy assessments of this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the efficacy of USV Pegfilgrastim compared to Neulasta® with respect to the mean duration of severe neutropenia (DSN) defined as the mean number of days with Grade 4 neutropenia [absolute neutrophil count (ANC) less than 0.5 × 109/L], during Cycle 1 of the chemotherapy treatment. ;Secondary Objective: To further compare USV Pegfilgrastim and Neulasta® with respect to the efficacy, safety, and immunogenicity of both products.;Primary end point(s): Mean duration of severe neutropenia (Grade 4), defined as the number of days in which the subject has an ANC < 0.5 × 109/L during Cycle 1 of chemotherapy.;Timepoint(s) of evaluation of this end point: Cycle 1 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary efficacy endpoints: •Mean duration of severe neutropenia (DSN) during cycles 2 to 6; •Depth of ANC nadir, defined as the subject’s lowest ANC in Cycles 1 to 6; •The number and proportion of subjects with febrile neutropenia episodes defined as single temperature: =38,3°C measured orally or =38,0°C for over 1 hour; neutropenia: ANC 2.0 × 109/L after the nadir in Cycle 1; •The number and proportion of subjects hospitalised, duration of hospitalisations and time in intensive care unit (ICU) due to neutropenia complications by cycle; •The number and proportion of subjects with clinically documented infections by cycle; •Use of intravenous (i.v.) antibiotics during each cycle. Safety Endpoints: •Probability of occurrence, and severity of the most common adverse events (AEs) associated with Pegfilgrastim treatment; •Bone pain; •Probability of occurrence, and severity of other AEs including mortality during treatment for any cause; •Assessment of local tolerability at the injection site(s); •Systemic tolerance (physical examination, vital signs, and laboratory assessments of safety parameters); •Immunogenicity assessments up to six months after the last dose of the IMP.;Timepoint(s) of evaluation of this end point: Cycles 1-6 and six months follow up period | — |
Countries
Bosnia and Herzegovina, Bulgaria, Egypt, Georgia, Hungary, Poland, Romania, Russian Federation, Serbia, Turkey, Ukraine
Contacts
Public ContactClinical Trials Info
Accelsiors CRO and Consultancy Services Ltd
Outcome results
None listed