Solid TumorDef_SpecialNCT04905329
A Multicenter Prospective Post-registration Study of Empegfilgrastim to Evaluate Safety and Efficacy in Special Cancer Populations
An observational study of Solid Tumor and High-Risk Cancer, run by Moscow Clinical Scientific Center at 3 sites in Russia.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Solid Tumor, High-Risk Cancer, Breast Cancer
- What is being tested?
- Empegfilgrastim
- How many people
- 285 participants
- Where
- 3 sitesRussia
- Study dates
- 28 Apr 2020to 1 Sep 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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;
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- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
3 sites in 1 country.
Russia3 sites, 3 recruiting
- Recruiting
Moscow Clinical Scientific Center named after AS Loginov
Moscow, Not Required, 111123
Lyudmila Zhukova, MD, PhD, professor
- Recruiting
FSBI NMITs oncology named after N.N. Blokhin, the Ministry of Health of Russia
Moscow, Not Required
Alexey Tryakin, MD, PhD, professor
Inna Ganshina, MD, PhD
- 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
Moscow
Svetlana Khlokhlova, MD, PhD
Svetlana Khlokhlova, MD, PhD
About this study
Official title: 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
- Conditions
- Solid Tumor, High-Risk Cancer, Breast Cancer, Gastrointestinal Cancer, Gynecological Malignancies, Myelosuppression
- Being tested
- Empegfilgrastim
- Medical subject headings
- Breast Neoplasms, Gastrointestinal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EmpegfilgrastimDrug
Extimia®
| Study group | Role | What they receive |
|---|---|---|
| Patients with high and "gray zone" risk reccurrence early breast cancer | Not described Receives: Drug: Empegfilgrastim | |
| Patients with gastointestinal cancers | Not described Receives: Drug: Empegfilgrastim | |
| Patients with gynecological malignancies | Not described Receives: Drug: Empegfilgrastim |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relative dose-intensity (RDI) of the myelosupressive therapy course
Measured: 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
Measured: 18 months
RDI of FOLFOX-, FOLFOXIRI-based regimens performed in relation to (neo) adjuvant therapy of colorectal cancer
Measured: 18 months
RDI of FOLFOX-, FOLFOXIRI-based regimens performed in relation to patients with potentially resectable liver metastases of colorectal cancer
Measured: 18 months
RDI of DCF-, FOLFORINOX-based regimens performed in relation to therapy of pancreatic cancer
Measured: 18 months
RDI of DCF-, FOLFORINOX-, FLOT-, FOLFOX-based regimens performed in relation to therapy of gastric and esophageal cancers
Measured: 18 months
RDI of chemotherapy courses performed in patients with cervical cancer and sarcoma of the uterus after irradiation of the pelvic organs
Measured: 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
Measured: 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
Measured: 18 months
The incidence of febrile neutropenia with empegfilgrastim supportive therapy compared with historical control
Measured: 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
Measured: 18 months
Completed cases number of (neo) adjuvant therapy
Measured: 18 months
The incidence of severe infections (grade 3-4)
Measured: 18 months
Frequency of antibiotic prescription
Measured: 18 months
Frequency of study withdrawal due to adverse events
Measured: 18 months
RCB rate in patients with breast cancer
Measured: 18 months
Any grade adverse events frequency
Measured: 18 months
Serious adverse events frequency
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2021
- Study start28 Apr 2020
- Primary completion31 Dec 2022 (estimated)
- Study completion1 Sep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 285 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Moscow Clinical Scientific Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhukova Lyudmila, Moscow Clinical Scientific Center
- Investigators
- Inna Ganshina, MD, PhD, Principal investigator, FSBI NMITs oncology named after N.N. Blokhin, the Ministry of Health of RussiaLyudmila Zhukova, MD, PhD, professor, Study chair, Moscow Clinical Scientific Center named after AS LoginovAlexey Tryakin, MD, PhD, professor, Principal investigator, FSBI NMITs oncology named after N.N. Blokhin, the Ministry of Health of RussiaMikhail Fedyanin, MD, PhD, professor, Principal investigator, FSBI NMITs oncology named after N.N. Blokhin, the Ministry of Health of RussiaSvetlana Khokhlova, MD, PhD, Principal investigator, FSBI "National medical research center for obstetrics, gynecology and perinatology named after academician VI Kulakov" Ministry of healthcare of the Russian Federation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04905329
- Sponsor's protocol ID
- DS_v01
- Acronym
- Def_Special
- Status last verified
- May 2021
- First submitted
- 24 May 2021
- Last updated
- 2 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04905329
- Acronym / sponsor ID
- Def_Special / DS_v01
- Conditions
- Solid Tumor, High-Risk Cancer, Breast Cancer, Gastrointestinal Cancer, Gynecological Malignancies, Myelosuppression
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 285 participants (estimated)
- Lead sponsor
- Moscow Clinical Scientific CenterUniversity, hospital or other
- Study start
- 28 Apr 2020 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 1 Sep 2023 (estimated)
- First posted
- 27 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (14 listed)
- 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:
Key exclusion criteria (9 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EmpegfilgrastimExtimia® | Drug | Patients with gastointestinal cancers, Patients with gynecological malignancies, Patients with high and "gray zone" risk reccurrence early breast cancer |
Primary outcome
Relative dose-intensity (RDI) of the myelosupressive therapy course
Time frame: 12 months
17 secondary outcomes
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
RDI of FOLFOX-, FOLFOXIRI-based regimens performed in relation to (neo) adjuvant therapy of colorectal cancer
Time frame: 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
RDI of DCF-, FOLFORINOX-based regimens performed in relation to therapy of pancreatic cancer
Time frame: 18 months
RDI of DCF-, FOLFORINOX-, FLOT-, FOLFOX-based regimens performed in relation to therapy of gastric and esophageal cancers
Time frame: 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
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
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
The incidence of febrile neutropenia with empegfilgrastim supportive therapy compared with historical control
Time frame: 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
Completed cases number of (neo) adjuvant therapy
Time frame: 18 months
The incidence of severe infections (grade 3-4)
Time frame: 18 months
Frequency of antibiotic prescription
Time frame: 18 months
Frequency of study withdrawal due to adverse events
Time frame: 18 months
RCB rate in patients with breast cancer
Time frame: 18 months
Any grade adverse events frequency
Time frame: 18 months
Serious adverse events frequency
Time frame: 18 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Inna Ganshina, MD, PhD principal investigator
FSBI NMITs oncology named after N.N. Blokhin, the Ministry of Health of Russia
Lyudmila Zhukova, MD, PhD, professor study chair
Moscow Clinical Scientific Center named after AS Loginov
Alexey Tryakin, MD, PhD, professor principal investigator
FSBI NMITs oncology named after N.N. Blokhin, the Ministry of Health of Russia
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Solid Tumor and High-Risk Cancer, run by Moscow Clinical Scientific Center at 3 sites in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lyudmila Zhukova, MD, PhD, professor (+74953043035, lyudmila.zhukova@mail.ru), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Relative dose-intensity (RDI) of the myelosupressive therapy course (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2021.