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

• Conditions: Solid Tumor; Gynecological Malignancies; Myelosuppression; High-Risk Cancer; Gastrointestinal Cancer; Breast Cancer
• Interventions: Drug: Empegfilgrastim

• Registration Number: NCT04905329
• Lead Sponsor: Moscow Clinical Scientific Center

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

Detailed Description

Not available

Study Timeline

• Study Start: 2020-04-28
• Status Verified: 2021-05
• Study First Submitted: 2021-05-24
• Study First Submitted QC: 2021-05-24
• Study First Posted: 2021-05-27
• Last Update Submitted: 2021-05-31
• Last Update Posted: 2021-06-02
• Primary Completion: 2022-12-31
• Study Completion: 2023-09-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 285

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;

7. 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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with high and "gray zone" risk reccurrence early breast cancer	Empegfilgrastim	-
Patients with gastointestinal cancers	Empegfilgrastim	-
Patients with gynecological malignancies	Empegfilgrastim	-

Primary Outcome Measures

Name	Time	Method
Relative dose-intensity (RDI) of the myelosupressive therapy course	12 months

Secondary Outcome Measures

Name	Time	Method
Any grade adverse events frequency	18 months
RDI of FOLFOX-, FOLFOXIRI-based regimens performed in relation to (neo) adjuvant therapy of colorectal cancer	18 months
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 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
The incidence of severe infections (grade 3-4)	18 months
Serious adverse events frequency	18 months
RDI of chemotherapy courses performed in patients with cervical cancer and sarcoma of the uterus after irradiation of the pelvic organs	18 months
Frequency of study withdrawal due to adverse events	18 months
RCB rate in patients with breast cancer	18 months
The complete pathological responses (pCR) rate in the primary tumors for patients diagnosed with HER2 + and triple negative early breast cancer requiring neoadjuvant treatment	18 months
The complete pathological responses (pCR) rate in the malignant lymph nodes for patients diagnosed with HER2 + and triple negative early breast cancer requiring neoadjuvant treatment	18 months
The incidence of febrile neutropenia with empegfilgrastim supportive therapy compared with historical control	18 months
Frequency of antibiotic prescription	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
Completed cases number of (neo) adjuvant therapy	18 months

Trial Locations

Locations (3)

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

Moscow Clinical Scientific Center named after AS Loginov; 🇷🇺 Moscow, Not Required, Russian Federation

FSBI NMITs oncology named after N.N. Blokhin, the Ministry of Health of Russia; 🇷🇺 Moscow, Not Required, Russian Federation