Patients With Solid Tumours Who Receive Myelosupressive Therapy Clinical Trial
— DEFENDOROfficial title:
DEFENDOR: A Multicenter Prospective Observational Post-registration stuDy of Extimia® (INN: empEgfilrastim) to Evaluate Efficacy and saFEty in patieNts With soliD tumORs
| Verified date | March 2021 |
| Source | Biocad |
| Contact | Irina Sorokina, PhD |
| Phone | +7 (812) 380 49 33 |
| biocad[@]biocad.ru | |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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
| Status | Recruiting |
| Enrollment | 500 |
| Est. completion date | June 12, 2022 |
| Est. primary completion date | June 12, 2022 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 80 Years |
| Eligibility | 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 ? 10(9) /L; - Platelets = 100 ? 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. |
| Country | Name | City | State |
|---|---|---|---|
| Russian Federation | St. Josaphat Belgorod Regional Clinical Hospital | Belgorod | |
| Russian Federation | State Health Institution "Voronezh Region Clinical Oncology Dispansary" | Voronezh | |
| Russian Federation | Regional Clinical Oncology Hospital | Yaroslavl | Yaroslavskaya Oblast |
| Lead Sponsor | Collaborator |
|---|---|
| Biocad |
Russian Federation,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Relative dose-intensity (RDI) of the myelosupressive therapy course | 12 months | ||
| Secondary | The incidence of febrile neutropenia with empegfilgrastim supportive therapy compared with historical control | 18 months | ||
| Secondary | 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 | ||
| Secondary | RDI of chemotherapy courses performed in relation to nosology | 18 months | ||
| Secondary | RDI of chemotherapy courses performed in relation to treatment regimen | 18 months | ||
| Secondary | Any grade adverse events frequency | 18 months | ||
| Secondary | Grade 3-4 adverse events frequency | 18 months | ||
| Secondary | Serious adverse events frequency | 18 months | ||
| Secondary | Frequency of study withdrawal due to adverse events | 18 months | ||
| Secondary | The incidence of severe infections (grade 3-4) | 18 months | ||
| Secondary | Frequency of antibiotic prescription | 18 months |