Status:
UNKNOWN
A Multicenter Prospective Post-registration Study of Empegfilgrastim to Evaluate Safety and Efficacy in Special Cancer Populations
Lead Sponsor:
Moscow Clinical Scientific Center
Conditions:
Solid Tumor
High-Risk Cancer
Eligibility:
All Genders
18-80 years
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 ...
Eligibility Criteria
Inclusion
- 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;
- 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
- 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.
Key Trial Info
Start Date :
April 28 2020
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
September 1 2023
Estimated Enrollment :
285 Patients enrolled
Trial Details
Trial ID
NCT04905329
Start Date
April 28 2020
End Date
September 1 2023
Last Update
June 2 2021
Active Locations (3)
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1
Moscow Clinical Scientific Center named after AS Loginov
Moscow, Not Required, Russia, 111123
2
FSBI NMITs oncology named after N.N. Blokhin, the Ministry of Health of Russia
Moscow, Not Required, Russia
3
FSBI "National medical research center for obstetrics, gynecology and perinatology named after academician VI Kulakov" Ministry of healthcare of the Russian Federation
Moscow, Russia