- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04905329
A Multicenter Prospective Post-registration Study of Empegfilgrastim to Evaluate Safety and Efficacy in Special Cancer Populations (Def_Special)
May 31, 2021 updated by: Zhukova Lyudmila, Moscow Clinical Scientific Center
Defendor Special: A Multicenter Prospective Observational Post-registration Study of Combined Chemotherapy With Empegfilrastim Support to Evaluate Safety and Efficacy in Patients With High and "Gray Zone" Risk Reccurrence Breast Cancer, Gastointestinal Cancers and Gynecological Malignancies
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
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Anticipated)
285
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Lyudmila Zhukova, MD, PhD, professor
- Phone Number: +74953043035
- Email: lyudmila.zhukova@mail.ru
Study Locations
-
-
-
Moscow, Russian Federation
- Not yet recruiting
- FSBI "National medical research center for obstetrics, gynecology and perinatology named after academician VI Kulakov" Ministry of healthcare of the Russian Federation
-
Contact:
- Svetlana Khlokhlova, MD, PhD
-
Principal Investigator:
- Svetlana Khlokhlova, MD, PhD
-
-
Not Required
-
Moscow, Not Required, Russian Federation, 111123
- Recruiting
- Moscow Clinical Scientific Center named after AS Loginov
-
Contact:
- Lyudmila Zhukova, MD, PhD, professor
-
Moscow, Not Required, Russian Federation
- Recruiting
- FSBI NMITs oncology named after N.N. Blokhin, the Ministry of Health of Russia
-
Contact:
- Alexey Tryakin, MD, PhD, professor
-
Contact:
- Inna Ganshina, MD, PhD
-
Principal Investigator:
- Mikhail Fedyanin, MD, PhD, professor
-
Principal Investigator:
- Inna Ganshina, MD, PhD
-
Principal Investigator:
- Alexey Tryakin, MD, PhD, professor
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
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 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.
Description
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 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;
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:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Patients with high and "gray zone" risk reccurrence early breast cancer
|
Extimia®
|
Patients with gastointestinal cancers
|
Extimia®
|
Patients with gynecological malignancies
|
Extimia®
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Relative dose-intensity (RDI) of the myelosupressive therapy course
Time Frame: 12 months
|
12 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The incidence of febrile neutropenia with empegfilgrastim supportive therapy compared with historical control
Time Frame: 18 months
|
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
Time Frame: 18 months
|
18 months
|
Any grade adverse events frequency
Time Frame: 18 months
|
18 months
|
Serious adverse events frequency
Time Frame: 18 months
|
18 months
|
Frequency of study withdrawal due to adverse events
Time Frame: 18 months
|
18 months
|
The incidence of severe infections (grade 3-4)
Time Frame: 18 months
|
18 months
|
Frequency of antibiotic prescription
Time Frame: 18 months
|
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
Time Frame: 18 months
|
18 months
|
RDI of FOLFOX-, FOLFOXIRI-based regimens performed in relation to (neo) adjuvant therapy of colorectal cancer
Time Frame: 18 months
|
18 months
|
RDI of FOLFOX-, FOLFOXIRI-based regimens performed in relation to patients with potentially resectable liver metastases of colorectal cancer
Time Frame: 18 months
|
18 months
|
RDI of DCF-, FOLFORINOX-based regimens performed in relation to therapy of pancreatic cancer
Time Frame: 18 months
|
18 months
|
RDI of DCF-, FOLFORINOX-, FLOT-, FOLFOX-based regimens performed in relation to therapy of gastric and esophageal cancers
Time Frame: 18 months
|
18 months
|
RDI of chemotherapy courses performed in patients with cervical cancer and sarcoma of the uterus after irradiation of the pelvic organs
Time Frame: 18 months
|
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
Time Frame: 18 months
|
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
Time Frame: 18 months
|
18 months
|
Completed cases number of (neo) adjuvant therapy
Time Frame: 18 months
|
18 months
|
RCB rate in patients with breast cancer
Time Frame: 18 months
|
18 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Inna Ganshina, MD, PhD, FSBI NMITs oncology named after N.N. Blokhin, the Ministry of Health of Russia
- Study Chair: Lyudmila Zhukova, MD, PhD, professor, Moscow Clinical Scientific Center named after AS Loginov
- Principal Investigator: 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
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 28, 2020
Primary Completion (Anticipated)
December 31, 2022
Study Completion (Anticipated)
September 1, 2023
Study Registration Dates
First Submitted
May 24, 2021
First Submitted That Met QC Criteria
May 24, 2021
First Posted (Actual)
May 27, 2021
Study Record Updates
Last Update Posted (Actual)
June 2, 2021
Last Update Submitted That Met QC Criteria
May 31, 2021
Last Verified
May 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- DS_v01
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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