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

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

Study Overview

• Status: Recruiting
• Conditions: Patients With Solid Tumours Who Receive Myelosupressive Therapy
• Intervention / Treatment: Drug: Empegfilgrastim

• Study Type: Observational
• Enrollment (Anticipated): 500

Contacts and Locations

• Study Contact: Name: Irina Sorokina, PhD; Phone Number: +7 (812) 380 49 33; Email: biocad@biocad.ru
• Study Contact Backup: Name: Irina Khlopotkina, MD; Phone Number: +7 (812) 380 49 33; Email: biocad@biocad.ru

Study Locations

• Russian Federation
  • Belgorod, Russian Federation
    • Recruiting
    • St. Josaphat Belgorod Regional Clinical Hospital
  • Voronezh, Russian Federation, 394000
    • Recruiting
    • State Health Institution "Voronezh Region Clinical Oncology Dispansary"
  • Yaroslavskaya Oblast
    • Yaroslavl, Yaroslavskaya Oblast, Russian Federation, 150054
      • Recruiting
      • Regional Clinical Oncology Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients with solid tumors who have received myelosupressive therapy	Drug: Empegfilgrastim; Extimia®

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Relative dose-intensity (RDI) of the myelosupressive therapy course	12 months

Secondary Outcome Measures

Outcome Measure	Time Frame
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
Grade 3-4 adverse events frequency	18 months
Serious adverse events frequency	18 months
Frequency of study withdrawal due to adverse events	18 months
The incidence of severe infections (grade 3-4)	18 months
Frequency of antibiotic prescription	18 months

Collaborators and Investigators

• Sponsor: Biocad

Study record dates

Study Major Dates

• Study Start (Actual): January 12, 2021
• Primary Completion (Anticipated): June 12, 2022
• Study Completion (Anticipated): June 12, 2022

Study Registration Dates

• First Submitted: March 19, 2021
• First Submitted That Met QC Criteria: March 19, 2021
• First Posted (Actual): March 23, 2021

Study Record Updates

• Last Update Posted (Actual): March 23, 2021
• Last Update Submitted That Met QC Criteria: March 19, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: BCD-017-01-NIS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No