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

NCT04905329 | Unknown

• 1 other identifier: DS_v01
• Study Type: observational
• Target: 285
• 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 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

Outcome Measures

Primary Outcomes (1)

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

  12 months

Secondary Outcomes (17)

• RDI of 6 x TC, 6 x TCHP, ddAC x4 -> 4 x paclitaxel , dd4AC -> 4 x paclitaxel + 12 x carboplatin) regimens performed in relation to (neo) adjuvant therapy of breast cancer

  18 months

• RDI of FOLFOX-, FOLFOXIRI-based regimens performed in relation to (neo) adjuvant therapy of colorectal cancer

  18 months

• RDI of FOLFOX-, FOLFOXIRI-based regimens performed in relation to patients with potentially resectable liver metastases of colorectal cancer

  18 months

• RDI of DCF-, FOLFORINOX-based regimens performed in relation to therapy of pancreatic cancer

  18 months

• RDI of DCF-, FOLFORINOX-, FLOT-, FOLFOX-based regimens performed in relation to therapy of gastric and esophageal cancers

  18 months

Study Arms (3)

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

Drug: Empegfilgrastim

Patients with gastointestinal cancers

Drug: Empegfilgrastim

Patients with gynecological malignancies

Drug: Empegfilgrastim

Interventions

Empegfilgrastim DRUG

Extimia®

Patients with gastointestinal cancers; Patients with gynecological malignancies; Patients with high and "gray zone" risk reccurrence early breast cancer

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 high and "gray zone" risk reccurrence breast cancer, gastointestinal cancers and gynecological malignancies who are prescribed myelosuppressive therapy with empegfilgrastim supportive therapy to support planned RDI, 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; 9. Ability of the patient to comply with the Protocol requirements.

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

• Moscow Clinical Scientific Center: lead

Study Sites (3)

Moscow Clinical Scientific Center named after AS Loginov

Moscow, Not Required, 111123, Russia

RECRUITING

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

Moscow, Not Required, Russia

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

NOT YET RECRUITING

MeSH Terms

Conditions

Breast Neoplasms; Gastrointestinal Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases

Study Officials

• Inna Ganshina, MD, PhD

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

  PRINCIPAL INVESTIGATOR

• Lyudmila Zhukova, MD, PhD, professor

  Moscow Clinical Scientific Center named after AS Loginov

  STUDY CHAIR

• Alexey Tryakin, MD, PhD, professor

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

  PRINCIPAL INVESTIGATOR

• Mikhail Fedyanin, MD, PhD, professor

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

  PRINCIPAL INVESTIGATOR

• Svetlana Khokhlova, MD, PhD

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lyudmila Zhukova, MD, PhD, professor

CONTACT

+74953043035; lyudmila.zhukova@mail.ru

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Deputy Director of the Loginov Moscow Clinical Scientific Center, MD, PhD, Professor

Study Record Dates

• First Submitted: May 24, 2021
• First Posted: May 27, 2021
• Study Start: April 28, 2020
• Primary Completion: December 31, 2022
• Study Completion: September 1, 2023
• Last Updated: June 2, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

RU (3)