breast cancer patients receiving myelosupressive chemotherapy (doxorubicin/docetaxel) MedDRA version: 12.1 Level: LLT Classification code 10006187 Term: Breast cancer
Conditions
Interventions
Product Name: Neugranin
Product Code: CG-10639
Pharmaceutical Form: Solution for injection
INN or Proposed INN: neugranin
CAS Number: 941579-28-8
Current Sponsor code: CG-10639, albugranin
Other descr
Sponsors
Teva Pharmaceutical Works Private Limited Company
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients with histologically or cytologically confirmed breast cancer scheduled to receive doxorubicin 60 mg/m2 and docetaxel 75 mg/m2 2. 18 years of age or older 3. Adequate hematologic function: ANC >/= 1.5 x 10 9/L; Platelets >/= 100 x10 9/L 4. Adequate hepatic and renal function:Serum creatinine /= lower limit of normal for the local institution 7. Have the ability to understand the requirements of the study, provide written informed consent (including consent for the use and disclosure of researchrelated health information), and comply with the study protocol procedures Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. More than 1 prior chemotherapy regimen (including adjuvant therapy if given within the last 12 months prior to study chemotherapy) 2. Prior lifetime cumulative anthracycline dose exceeding 240 mg/m2 doxorubicin or the equivalent dose of another anthracycline or anthracenedione 3. Prior chemotherapy/immunotherapy within 30 days prior to study chemotherapy (within 6 weeks of study chemotherapy for nitrosoureas (BCNU, CCNU) or mitomycin-C) 4. Concomitant trastuzumab (Herceptin) 5. Received any investigational agent within 30 days prior to study chemotherapy 6. Myocardial infarction within 6 months prior to study chemotherapy, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or ECG abnormalities that may interfere with the accurate assessment of the QT interval, including intraventricular conduction delays (QRS >120 msec) and complete bundle branch blocks 7. Prior surgery within 2 weeks of study chemotherapy 8. Prior radiation therapy within 4 weeks of study chemotherapy (except spot irradiation for bone metastases) 9. Prior high-dose chemotherapy with hematopoietic stem cell transplant 10. Prior use of G-CSF, GM-CSF or erythropoietin within 4 weeks of study chemotherapy 11. Received systemic antibiotics within 72 hours of study chemotherapy 12. History of myeloid malignancy or myelodysplasia 13. Known brain metastases unless adequately treated (surgery or radiotherapy), no evidence of progression with a minimum of 3 weeks observation and neurologically stable off anticonvulsants and steroids. 14. Known sickle cell disease 15. Diagnosis of ARDS 16. Known history of allergies to yeast-derived products 17. Known hypersensitivity to E. coli-derived proteins‚ pegfilgrastim‚ filgrastim, or any other component of pegfilgrastim 18. History of severe hypersensitivity reactions to docetaxel or other drugs formulated with polysorbate 80 such as etoposide and vitamin E 19. Hypersensitivity to doxorubicin, any of its excipients, or other anthracyclines or anthracenediones 20. Pregnant female or nursing mother. All non-sterile or non-postmenopausal females must have a negative serum pregnancy test at screening and must practice a medically accepted method of contraception over the course of the study and for 30 days after the last dose of study drug (acceptable methods of birth control in this study are: surgical sterilization, intrauterine devices, oral contraceptive, contraceptive patch, long-acting injectable contraceptive, partner’s vasectomy, a double-protection method (condom or diaphragm with spermicide). Hormonal contraception must be accompanied by an additional barrier method of birth control (condom). 21. Males who do not agree to use effective contraception throughout the study and for a period of 30 days after the last dose of study drug 22. Known HIV positive or active hepatitis (Patients with unknown status will not be tested)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the efficacy of Neugranin compared to pegfilgrastim in subjects receiving doxorubicin and docetaxel as evidenced by the duration of severe neutropenia (DSN) in Cycle 1;Secondary Objective: - To determine the incidence of febrile neutropenia and documented infections by cycle and across all cycles - To assess the incidence of severe neutropenia by cycle and across all cycles - To assess the duration of severe neutropenia in Cycles 2-4. - To assess the time to ANC recovery (ANC >/= 1.5 x 10 9/L) in Cycles 1-4;Primary end point(s): Primary Outcome Measure(s): Duration of severe neutropenia (severe neutropenia defined as an ANC < 0.5 x 109/L) in Cycle 1. | — |
Countries
Bulgaria
Outcome results
None listed