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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 | Clinical Trials | Clareo Health

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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

NCT04811443•Biocad

View on ClinicalTrials.gov

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 caused by febrile neutropenia in patients with solid tumours receiving myelosuppressive therapy

Eligibility

Age

18 - 80 years

Sex

ALL

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:
+6 more criteria

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.

Locations (3)

Regional Clinical Oncology Hospital

Yaroslavl, Yaroslavl Oblast, Russia

St. Josaphat Belgorod Regional Clinical Hospital

Belgorod, Russia

State Health Institution "Voronezh Region Clinical Oncology Dispansary"

Voronezh, Russia

Key Dates

Start Date

January 12, 2021

Primary Completion Date

June 12, 2022

Completion Date

June 12, 2022

Last Updated

March 23, 2021

Enrollment

500

ESTIMATED participants

Conditions

Patients With Solid Tumours Who Receive Myelosupressive Therapy

Interventions

Empegfilgrastim

DRUG

Contacts

Irina Sorokina, PhD

CONTACT

+7 (812) 380 49 33 biocad@biocad.ru

Irina Khlopotkina, MD

CONTACT

+7 (812) 380 49 33 biocad@biocad.ru