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

NCT ID: NCT04905329

Last Updated: 2021-06-02

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 285 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-04-28
• Study Completion Date: 2023-09-01

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

Conditions

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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

Empegfilgrastim

Intervention Type: DRUG

Extimia®

Patients with gastointestinal cancers

Empegfilgrastim

Intervention Type: DRUG

Extimia®

Patients with gynecological malignancies

Empegfilgrastim

Intervention Type: DRUG

Extimia®

Interventions

Empegfilgrastim

Extimia®

Intervention Type: DRUG

Eligibility Criteria

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;

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Moscow Clinical Scientific Center

OTHER

Sponsor Role: lead

Responsible Party

Zhukova Lyudmila

Deputy Director of the Loginov Moscow Clinical Scientific Center, MD, PhD, Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Inna Ganshina, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

FSBI NMITs oncology named after N.N. Blokhin, the Ministry of Health of Russia

Lyudmila Zhukova, MD, PhD, professor

Role: STUDY_CHAIR

Moscow Clinical Scientific Center named after AS Loginov

Alexey Tryakin, MD, PhD, professor

Role: PRINCIPAL_INVESTIGATOR

FSBI NMITs oncology named after N.N. Blokhin, the Ministry of Health of Russia

Mikhail Fedyanin, MD, PhD, professor

Role: PRINCIPAL_INVESTIGATOR

FSBI NMITs oncology named after N.N. Blokhin, the Ministry of Health of Russia

Svetlana Khokhlova, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

FSBI "National medical research center for obstetrics, gynecology and perinatology named after academician VI Kulakov" Ministry of healthcare of the Russian Federation

Locations

Moscow Clinical Scientific Center named after AS Loginov

Moscow, Not Required, Russia

Site Status: RECRUITING

FSBI NMITs oncology named after N.N. Blokhin, the Ministry of Health of Russia

Moscow, Not Required, Russia

Site Status: RECRUITING

FSBI "National medical research center for obstetrics, gynecology and perinatology named after academician VI Kulakov" Ministry of healthcare of the Russian Federation

Moscow, , Russia

Site Status: NOT_YET_RECRUITING

Countries

Russia

Central Contacts

Lyudmila Zhukova, MD, PhD, professor

Role: CONTACT

lyudmila.zhukova@mail.ru

+74953043035

Facility Contacts

Lyudmila Zhukova, MD, PhD, professor

Role: primary

Alexey Tryakin, MD, PhD, professor

Role: primary

Inna Ganshina, MD, PhD

Role: backup

Svetlana Khlokhlova, MD, PhD

Role: primary

Other Identifiers

DS_v01

Identifier Type: -

Identifier Source: org_study_id