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

  • STATUS
    Recruiting
  • End date
    Sep 1, 2023
  • participants needed
    285
  • sponsor
    Moscow Clinical Scientific Center
Updated on 11 June 2021
cancer
absolute neutrophil count

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

Details
Condition cancer, breast, gastrointestinal cancer, Gastrointestinal Diseases and Disorders, Digestive System Neoplasms, Solid Neoplasm, Solid Tumors, Solid Tumour, High-Risk Cancer, Gynecological Malignancies, Breast Cancer, Myelosuppression, breast carcinoma, Solid Tumor, gastrointestinal cancers, Patients With High and Gray Zone Risk Reccurrence Solid Tumors Who Receive Myelosupressive Therapy, GASTROINTESTINAL DISORDER, Neoplasm of unspecified nature of digestive system, Gastrointestinal Neoplasm, Breast Cancer Diagnosis
Treatment Empegfilgrastim
Clinical Study IdentifierNCT04905329
SponsorMoscow Clinical Scientific Center
Last Modified on11 June 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

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 10(9) /L
Platelets 100 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

Exclusion Criteria

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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