Patients With Solid Tumours Who Receive Myelosupressive Therapy
Conditions
Brief summary
This study was designed to evaluate the efficacy and safety of Extimia® (INN - empegfilgrastim) in reducing the frequency, duration of neutropenia, the incidence of febrile neutropenia and infections caused by febrile neutropenia in patients with solid tumours receiving myelosuppressive therapy
Interventions
DRUGEmpegfilgrastim
Extimia®
Sponsors
Biocad
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Signed informed consent form; 2. Histologically verified diagnosis; 3. Age between 18 and 80 years; 4. If the patient had previously received chemotherapy for these indications, then it should be completed at least 30 days before the first administration of the study drug; 5. ECOG performance 0-2; 6. Haematology: * ANC ≥ 1,5 х 10(9) /L; * Platelets ≥ 100 х 10(9) /L; * Hemoglobin ≥ 90 g/L; 7. Biochemistry: * Creatinine ≤ 1,5 ULN; * Total bilirubin ≤ 1,5 ULN; * AST/ALT ≤ 2,5 ULN; * Alkaline phosphatase ≤ 5 ULN; 8. Life expectancy of at least 6 months from the date of the first drug administration in the study; 9. Ability of the patient to comply with the Protocol requirements.
Exclusion criteria
1. Documented hypersensitivity to empegfilgrastim, filgrastim, pegfilgrastim, and / or their constituent excipients: pegylated drugs, protein recombinant drugs; 2. Systemic use of antibiotics less than 72 hours before the first drug administration in the study; 3. Concurrent or less than 30 days before the start of the study, radiation therapy (with the exception of point radiation therapy for bone metastases); study; 4. Concurrent participation in clinical trials, participation in clinical trials within the previous 30 days, previous participation in this study; 5. Surgical treatment less than 21 days (3 weeks) prior to study enrollment; taking any experimental medications less than 30 days before enrollment in this study; 6. History of bone marrow or hematopoietic stem cell transplantation; 7. Presence of acute or active chronic infections; 8. Other diseases (with the exception of the main one) that could affect the assessment of the severity of the symptoms of the underlying disease: that may mask, enhance, change the symptoms of the underlying disease or cause clinical manifestations and changes in the data of laboratory and instrumental research methods; 9. Inability to administer the drug by intravenous infusion or subcutaneous injection.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Relative dose-intensity (RDI) of the myelosupressive therapy course | 12 months |
Secondary
| Measure | Time frame |
|---|---|
| The incidence of neutropenia leading to a dose reduction of cytostatic drugs and / or an increase of the interval between cycles when using empegfilgrastim supportive therapy compared with historical controls | 18 months |
| RDI of chemotherapy courses performed in relation to nosology | 18 months |
| RDI of chemotherapy courses performed in relation to treatment regimen | 18 months |
| Any grade adverse events frequency | 18 months |
| The incidence of febrile neutropenia with empegfilgrastim supportive therapy compared with historical control | 18 months |
| Serious adverse events frequency | 18 months |
| Frequency of study withdrawal due to adverse events | 18 months |
| The incidence of severe infections (grade 3-4) | 18 months |
| Frequency of antibiotic prescription | 18 months |
| Grade 3-4 adverse events frequency | 18 months |
Countries
Russia
Contacts
Primary ContactIrina Sorokina, PhD
Backup ContactIrina Khlopotkina, MD
Outcome results
None listed