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

Biocad

Status: Unknown

Conditions: Patients With Solid Tumours Who Receive Myelosupressive Therapy

Treatments: Drug: Empegfilgrastim

Study type: Observational

Funder types: Industry

Identifiers

NCT04811443

BCD-017-01-NIS

Details and patient eligibility

About

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

Enrollment: 500 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

500 participants in 1 patient group

Patients with solid tumors who have received myelosupressive therapy

Treatment:

Drug: Empegfilgrastim