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

NCT04811443 | Unknown

• 1 other identifier: BCD-017-01-NIS
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 3

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

Conditions

Patients With Solid Tumours Who Receive Myelosupressive Therapy

Outcome Measures

Primary Outcomes (1)

• Relative dose-intensity (RDI) of the myelosupressive therapy course

  12 months

Secondary Outcomes (10)

• The incidence of febrile neutropenia with empegfilgrastim supportive therapy compared with historical control

  18 months

• 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

• RDI of chemotherapy courses performed in relation to nosology

  18 months

• RDI of chemotherapy courses performed in relation to treatment regimen

  18 months

• Any grade adverse events frequency

  18 months

Study Arms (1)

Patients with solid tumors who have received myelosupressive therapy

Drug: Empegfilgrastim

Interventions

Empegfilgrastim DRUG

Extimia®

Patients with solid tumors who have received myelosupressive therapy

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with solid tumors who are prescribed myelosuppressive therapy with empegfilgrastim supportive therapy to reduce the frequency, duration of neutropenia, the incidence of febrile neutropenia (FN) and infections manifested by FN, as part of routine clinical practice according to the approved indications of the appropriate drugs.

You may qualify if:

• 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;
• Life expectancy of at least 6 months from the date of the first drug administration in the study;

You may not qualify if:

• 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.

Sponsors & Collaborators

• Biocad: lead

Study Sites (3)

Regional Clinical Oncology Hospital

Yaroslavl, Yaroslavl Oblast, 150054, Russia

RECRUITING

St. Josaphat Belgorod Regional Clinical Hospital

Belgorod, Russia

RECRUITING

State Health Institution "Voronezh Region Clinical Oncology Dispansary"

Voronezh, 394000, Russia

RECRUITING

Central Study 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

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 19, 2021
• First Posted: March 23, 2021
• Study Start: January 12, 2021
• Primary Completion: June 12, 2022
• Study Completion: June 12, 2022
• Last Updated: March 23, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

RU (3)