DEFENDOR: A Multicenter Prospective Observational Post-registration stuDy of Extimia® (INN: empEgfilrastim) to Evaluate Efficacy and saFEty in patieNts With soliD tumORs

Study Overview
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Brief Summary
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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

Official Title
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DEFENDOR: A Multicenter Prospective Observational Post-registration stuDy of Extimia® (INN: empEgfilrastim) to Evaluate Efficacy and saFEty in patieNts With soliD tumORs

Conditions
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Patients With Solid Tumours Who Receive Myelosupressive Therapy

Intervention / Treatment
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* Drug: Empegfilgrastim


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Signed informed consent form; Histologically verified diagnosis; Age between 18 and 80 years; 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; ECOG performance 0-2; Haematology: ANC ≥ 1,5 х 10(9) /L; Platelets ≥ 100 х 10(9) /L; Hemoglobin ≥ 90 g/L; Biochemistry: Creatinine ≤ 1,5 ULN; Total bilirubin ≤ 1,5 ULN; AST/ALT ≤ 2,5 ULN; Alkaline phosphatase ≤ 5 ULN; Life expectancy of at least 6 months from the date of the first drug administration in the study; Ability of the patient to comply with the Protocol requirements. Exclusion Criteria: Documented hypersensitivity to empegfilgrastim, filgrastim, pegfilgrastim, and / or their constituent excipients: pegylated drugs, protein recombinant drugs; Systemic use of antibiotics less than 72 hours before the first drug administration in the study; 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; Concurrent participation in clinical trials, participation in clinical trials within the previous 30 days, previous participation in this study; 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; History of bone marrow or hematopoietic stem cell transplantation; Presence of acute or active chronic infections; 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; Inability to administer the drug by intravenous infusion or subcutaneous injection.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with solid tumors who have received myelosupressive therapy<br> | Drug: Empegfilgrastim<br>* Extimia®<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Relative dose-intensity (RDI) of the myelosupressive therapy course |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The incidence of febrile neutropenia with empegfilgrastim supportive therapy compared with historical control |  | 18 months | 
| 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 | 
| Grade 3-4 adverse events frequency |  | 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 |