A Multicenter Prospective Post-registration Study of Empegfilgrastim to Evaluate Safety and Efficacy in Special Cancer Populations (Def_Special)

Moscow Clinical Scientific Center

Status: Unknown

Conditions: Solid Tumor; Breast Cancer; Gastrointestinal Cancer; Myelosuppression; Gynecological Malignancies; High-Risk Cancer

Treatments: Drug: Empegfilgrastim

Study type: Observational

Funder types: Other

Identifiers

NCT04905329

DS_v01

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 High and "Gray Zone" Risk Reccurrence Breast Cancer, Gastointestinal Cancers and Gynecological Malignancies

Enrollment: 285 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; 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;

4. ECOG performance 0-2;

5. Haematology:

   • ANC ≥ 1,5 х 10(9) /L;
   • Platelets ≥ 100 х 10(9) /L;
   • Hemoglobin ≥ 90 g/L;

6. Biochemistry:

   • Creatinine ≤ 1,5 ULN;
   • Total bilirubin ≤ 1,5 ULN;
   • AST/ALT ≤ 2,5 ULN;
   • Alkaline phosphatase ≤ 5 ULN;

7. 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

285 participants in 3 patient groups

Patients with high and "gray zone" risk reccurrence early breast cancer

Treatment:

Drug: Empegfilgrastim

Patients with gastointestinal cancers

Treatment:

Drug: Empegfilgrastim

Patients with gynecological malignancies

Treatment:

Drug: Empegfilgrastim