Neutropenia and febrile neutropenia in patients being treated with cytotoxic chemotherapy for malignancy. MedDRA version: 16.0 Level: PT Classification code 10029354 Term: Neutropenia System Organ Class: 10005329 - Blood and lymphatic system disorders MedDRA version: 16.0 Level: PT Classification code 10016288 Term: Febrile neutropenia System Organ Class: 10005329 - Blood and lymphatic system disorders
Conditions
Interventions
Product Code: RGB-02
Pharmaceutical Form: Solution for injection in pre-filled syringe
INN or Proposed INN: PEGFILGRASTIM
CAS Number: 208265-92-3
Current Sponsor code: RGB-02
Other descriptive name: P
Sponsors
Gedeon Richter Plc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Females = 18 and = 65 years of age. 2. Patients with invasive breast cancer (Stage IIB and III) appropriate for treatment with doxorubicin and docetaxel combination therapy in the neoadjuvant or adjuvant treatment setting. 3. ECOG performance status 0 or 1. 4. Chemotherapy naïve. 5. Adequate bone marrow function assessed during Screening, as indicated by: a. ANC = 1.5 x10^9/L, b. Platelet count = 100 x10^9/L, and c. Hemoglobin > 8 g/dL. 6. Adequate renal and hepatic function assessed during Screening, as indicated by: a. Estimated creatinine clearance = 50 mL/min calculated by the Cockcroft-Gault method, b. Bilirubin, aspartate transaminase, alanine transaminase =65 years) yes F.1.3.1 Number of subjects for this age range 10
Exclusion criteria
Exclusion criteria: 1. Pregnant or breast-feeding women. 2. Co-existing active infection, or received systemic anti-infectives within 4 weeks prior to the first dose of chemotherapy (Day 1 of Cycle 1). 3. Significant cardiovascular disease defined as any history of documented or current congestive heart failure, current high-risk uncontrolled arrhythmias, current uncontrolled angina pectoris, current clinically significant valvular disease, current evidence of transmural infarction on ECG, or any other significant cardiovascular disease which in the Investigator’s judgment contraindicates the planned therapy (especially doxorubicin). 4. Any malignancy other than the current breast cancer within the last 5 years prior to randomization, with the exception of cervical carcinoma in situ, non-melanoma skin cancer, or superficial bladder tumors (Ta, Tis, or T1) that have been successfully and curatively treated with no evidence of recurrent or residual disease. 5. Radiation therapy within 4 weeks prior to randomization into this study. 6. Concurrent anti-cancer therapy, including endocrine therapy, immunotherapy and monoclonal antibody therapy, and any concurrent treatment with bisphosphonates. 7. Prior bone marrow or stem cell transplantation. 8. Sickle cell disease. 9. Other investigational drug administration within 4 weeks prior to the first dose of chemotherapy (Day 1 of Cycle 1). 10. Previous exposure to filgrastim, lenograstim, or pegfilgrastim. 11. Known allergy to any of the study drugs, including chemotherapy agents. 12. Contraindication for use of corticosteroids. 13. Systemic corticosteroid therapy within 2 weeks prior to randomization into this study. The use of topical or inhaled corticosteroids within 2 weeks prior to randomization may be allowed at the discretion of the Investigator. 14. Any co-existing medical condition that in the Investigator’s judgment will substantially increase the risk associated with the patient’s participation in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess and compare the efficacy of RGB-02 versus Neulasta® in breast cancer patients receiving AT (docetaxel-doxorubicine) chemotherapy in adjuvant or neoadjuvant setting.;Secondary Objective: To evaluate safety and immunogenicity of RGB-02 compared to Neulasta® and collect long term safety and immunogenicity data for RGB-02;Primary end point(s): Duration of severe neutropenia (ANC < 0.5 x10^9/L) in Cycle 1 ;Timepoint(s) of evaluation of this end point: The length of severe neutropenia in Cycle 1 (given in days) will be determined via daily ANC assessments at the end of Cycle 1. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Duration of severe neutropenia (ANC < 0.5 x10^9/L) in Cycles 2, 3 and 4 2. Incidence of severe neutropenia in Cycle 1 3. Incidence of severe neutropenia in Cycle 2 4. Observed incidence of febrile neutropenia in Cycles 1 and 2 5. Overall incidence of febrile neutropenia in Cycles 1 and 2 6. Time to ANC recovery (reaching ANC = 2 x10^9/L) in Cycles 1 and 2 7. Depth of ANC nadir in Cycles 1 and 2;Timepoint(s) of evaluation of this end point: 1. Length of severe neutropenia in Cycles 2-4 (days) will be determined via daily ANC assessments at end of Cycle 2-4. 2. Proportion of patients developing severe neutropenia will be determined via daily ANC assessments in Cycle 1. 3. Proportion of patients developing severe neutropenia will be determined via daily ANC assessments in Cycle 2-4. 4. and 5. Incidence of febrile neutropenia will be evaluated in Cycle 1-2. 6. Time to ANC recovery is the no. of days from the time of the first ANC value <0.5 10^9/L until the time of first ANC value after this, where the ANC value is =2.0 x 10^9/L.This will be evaluated in Cycle 1-2. 7. Depth of nadir defined as the change from baseline ANC value (value at Day-1,Cycle 1) to the lowest value in the cycle and evaluated for Cycle 1-2. | — |
Countries
Bulgaria, Croatia, Czech Republic, Hungary, Russian Federation, Serbia, Ukraine
Contacts
Public ContactHerta Pálfi Goóts
Gedeon Richter Plc.
Outcome results
None listed