Chemotherapy-induced NeutropeniaPhase 2NCT01569087
Dose-finding Study of Empegfilgrastim for Neutropenia Prophylaxis in Patients With Breast Cancer
A Phase 2 study testing empegfilrastim and filgrastim in people with Chemotherapy-induced Neutropenia, run by Biocad at 5 sites in Russia.
Trial summary
The purpose of the study is to compare safety and efficacy of a single dose of empegfilgrastimt a dose of 3 or 6 mg versus daily administration of filgrastim at a dose of 5 μg/kg/day. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Chemotherapy-induced Neutropenia
- What is being tested?
- empegfilrastim and filgrastim
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 5 sitesRussia
- Study dates
- May 2012to Feb 2013
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed informed consent form;
- Histologically verified diagnosis of stage IIb/III/IV breast cancer;
- Age of 18-70 years inclusive;
- If the patient had received the chemotherapy for breast cancer, it should be finished 30 days before the beginning of the study;
- ECOG Performance Status of 0, 1 or 2, not increasing within during 2 weeks before randomization;
- ANC level of 1500/μL and more at the beginning of the study
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- Platelet count of 100 000/μL and more at the beginning of the study
- Hemoglobin level of 90 g/l and more
- Creatinine level <1.5 mg/dl
- Total bilirubin level <1.5 × the upper limit of normal (ULN)
- ALT and/or AST levels <2.5×ULN (5×ULN for patients with liver metastases);
- Alkaline phosphatase <5×ULN;
- Left ventricular ejection fraction >50% and more;
- If the patient had received adjuvant and/or neoadjuvant therapy, the cumulative dose of anthracyclines should not exceed 500 mg/m2 for doxorubicin or 500 mg/m2 for epirubicin;
- Ability of the participant to follow the protocol requirements, according to the Investigator's opinion;
- Patients of childbearing potential must implement reliable contraceptive measures during the study treatment, starting 4 weeks prior randomization and for 6 months after the last administration of the study drug.
Who cannot join
- Patient has received two or more chemotherapy regimens for the metastatic breast cancer;
- Documented hypersensitivity to filgrastim, pegfilgrastim, docetaxel, doxorubicin, dexamethasone and/or its excipients, PEGylated drugs, recombinant proteins.
- Pregnancy or breastfeeding;
- Systemic antibiotic therapy within 72 h prior empegfilgrastim/filgrastim administration;
- Concomitant radiotherapy (except selective radiotherapy of bone metastases);
- Surgery, radiotherapy (except selective radiotherapy of bone metastases), administration of any experimental drugs within 30 days prior randomization;
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- History of bone marrow/stem cell transplantation;
- Conditions limiting the patient's ability to follow the protocol;
- CTCAE grade 2/4 neuropathy
- HIV, HCV, HBV, T.Pallidum infection(s);
- Acute or active chronic infections.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Russia5 sites
Arkhangelsk District Clinical Oncology Dispensary
Arkhangelsk, 163045
Perm Region Oncology Dispensary
Perm, 614066
N.N.Petrov Oncology Research Center
Saint Petersburg, 197758
Russian scientific center of radiology and surgery technologies
Saint Petersburg
Volgograd District Oncology Dispensary №1
Volgograd, 400138
About this study
Official title: Randomized Multicenter Open-label Phase II Clinical Study Comparing the Efficacy and Safety of the Single Dose of Extimia® Versus Daily Filgrastim for Neutropenia Prophylaxis in Breast Cancer Patients Receiving Myelosuppressive Chemotherapy
The purpose of the study is to compare safety and efficacy of a single dose of empegfilgrastimt a dose of 3 or 6 mg versus daily administration of filgrastim at a dose of 5 μg/kg/day.
Read the detailed description
BCD-017-2 is an open-label randomized phase II clinical study to compare the incidence of CTCAE grade 3/4 neutropenia after a single administration of recombinant human pegylated filgrastim empegfilgrastim (Extimia®) at a dose of 3 or 6 mg versus daily administration of filgrastim at a dose of 5 μg/kg/day for neutropenia prophylaxis in breast cancer patients receiving myelosuppressive chemotherapy.
- Conditions
- Chemotherapy-induced Neutropenia
- Being tested
- empegfilrastim, filgrastim
- Keywords
- empegfilgrastim, pegylated filgrastim, neutropenia, febrile neutropenia, chemotherapy-associated neutropenia, breast cancer, docetaxel, doxorubicin
- Medical subject headings
- Neutropenia, Febrile Neutropenia, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
empegfilrastimBiological
Also called Extimia, BCD-017, metpegfilgrastim, pegylated filgrastim
Empegfilgrastim is supplied as solution for injection 3 mg/ml. Empegfilgrastim is to be administered 24 h after the chemotherapy at dose of 3 or 6 mg.
filgrastimBiological
Also called GCSF
Filgrastim should be administered no earlier than 24 hours after the administration of cytotoxic chemotherapy. Filgrastim should be administered daily for up to 2 weeks until the ANC has reached 10 000/mm3 following the expected chemotherapy-induced neutrophil nadir.
| Study group | Role | What they receive |
|---|---|---|
| Empegfilgrastim 3 mg | Experimental | Patients will receive a single administration of empegfilgrastim at a dose of 3 mg subcutaneously , 24 h after the chemotherapy Receives: Biological: empegfilrastim |
| Empegfilgrastim 6 mg | Experimental | Patients will receive a single administration of empegfilgrastim at a dose of 6 mg subcutaneously, 24 h after the chemotherapy Receives: Biological: empegfilrastim |
| Filgrastim | Active comparator | Patients will receive filgrastim subcutaneously daily (until ANC 10 000/μL or for 14 days, whichever occurred first), starting 24 h after the chemotherapy Receives: Biological: filgrastim |
What is being measured
The primary outcome is the main question the study is designed to answer.
CTCAE Grade 3/4 Neutropenia Incidence
Measured: 21 days
Secondary outcomes (5)
Mean Duration of CTCAE Grade 4 Neutropenia
Measured: 21 days
The Duration of Any Grade Neutropenia
Measured: 21 days
Low Level (Nadir) ANC x 10^9/L
Measured: 21 days
Duration of Neutropenia From Nadir to ANC < 2,0 x 10^9 Cells/L on the First Cycle of Chemotherapy
Measured: 21 days
Incidence of Febrile Neutropenia
Measured: 21 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2012 (estimated)
- Study startMay 2012
- Primary completionJan 2013
- Study completionFeb 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Chemotherapy-induced NeutropeniaStudies of the same condition, open and under way.
- More trials run by BiocadThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biocad
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Roman A. Ivanov, MD, PhD, Study director, Biocad
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01569087
- Sponsor's protocol ID
- BCD-017-2
- Status last verified
- Oct 2016
- First submitted
- 30 Mar 2012
- Last updated
- 5 Dec 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Multicenter Open-label Phase II Clinical Study Comparing the Efficacy and Safety of the Single Dose of Extimia® Versus Daily Filgrastim for Neutropenia Prophylaxis in Breast Cancer Patients Receiving Myelosuppressive Chemotherapy
- ClinicalTrials.gov ID
- NCT01569087
- Acronym / sponsor ID
- BCD-017-2
- Conditions
- Chemotherapy-induced Neutropenia
- Keywords
- empegfilgrastim, pegylated filgrastim, neutropenia, febrile neutropenia, chemotherapy-associated neutropenia, breast cancer, docetaxel, doxorubicin
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- BiocadIndustry (pharma, biotech, devices)
- Study start
- May 2012
- Primary completion
- Jan 2013 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 2 Apr 2012 (estimated)
- Results
- Posted 24 Oct 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to compare safety and efficacy of a single dose of empegfilgrastimt a dose of 3 or 6 mg versus daily administration of filgrastim at a dose of 5 μg/kg/day.
Detailed description
BCD-017-2 is an open-label randomized phase II clinical study to compare the incidence of CTCAE grade 3/4 neutropenia after a single administration of recombinant human pegylated filgrastim empegfilgrastim (Extimia®) at a dose of 3 or 6 mg versus daily administration of filgrastim at a dose of 5 μg/kg/day for neutropenia prophylaxis in breast cancer patients receiving myelosuppressive chemotherapy.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Empegfilgrastim 3 mg | Experimental | Biological: empegfilrastimPatients will receive a single administration of empegfilgrastim at a dose of 3 mg subcutaneously , 24 h after the chemotherapy |
| Empegfilgrastim 6 mg | Experimental | Biological: empegfilrastimPatients will receive a single administration of empegfilgrastim at a dose of 6 mg subcutaneously, 24 h after the chemotherapy |
| Filgrastim | Active comparator | Biological: filgrastimPatients will receive filgrastim subcutaneously daily (until ANC 10 000/μL or for 14 days, whichever occurred first), starting 24 h after the chemotherapy |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Signed informed consent form;
- Histologically verified diagnosis of stage IIb/III/IV breast cancer;
- Age of 18-70 years inclusive;
- If the patient had received the chemotherapy for breast cancer, it should be finished 30 days before the beginning of the study;
- ECOG Performance Status of 0, 1 or 2, not increasing within during 2 weeks before randomization;
Key exclusion criteria (11 listed)
- Patient has received two or more chemotherapy regimens for the metastatic breast cancer;
- Documented hypersensitivity to filgrastim, pegfilgrastim, docetaxel, doxorubicin, dexamethasone and/or its excipients, PEGylated drugs, recombinant proteins.
- Pregnancy or breastfeeding;
- Systemic antibiotic therapy within 72 h prior empegfilgrastim/filgrastim administration;
- Concomitant radiotherapy (except selective radiotherapy of bone metastases);
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 |
|---|---|---|
| empegfilrastimAlso: Extimia, BCD-017, metpegfilgrastim, pegylated filgrastimEmpegfilgrastim is supplied as solution for injection 3 mg/ml. Empegfilgrastim is to be administered 24 h after the chemotherapy at dose of 3 or 6 mg. | Biological | Empegfilgrastim 3 mg, Empegfilgrastim 6 mg |
| filgrastimAlso: GCSFFilgrastim should be administered no earlier than 24 hours after the administration of cytotoxic chemotherapy. Filgrastim should be administered daily for up to 2 weeks until the ANC has reached 10 000/mm3 following the expected chemotherapy-induced neutrophil nadir. | Biological | Filgrastim |
Primary outcome
CTCAE Grade 3/4 Neutropenia Incidence
Time frame: 21 days
5 secondary outcomes
Mean Duration of CTCAE Grade 4 Neutropenia
Time frame: 21 days
The Duration of Any Grade Neutropenia
Time frame: 21 days
Low Level (Nadir) ANC x 10^9/L
Time frame: 21 days
Duration of Neutropenia From Nadir to ANC < 2,0 x 10^9 Cells/L on the First Cycle of Chemotherapy
Time frame: 21 days
Incidence of Febrile Neutropenia
Time frame: 21 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Roman A. Ivanov, MD, PhD study director
Biocad
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing empegfilrastim and filgrastim in people with Chemotherapy-induced Neutropenia, run by Biocad at 5 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 16 inclusion and 11 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: finished, as of the sponsor's last update on 5 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Oct 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CTCAE Grade 3/4 Neutropenia Incidence (time frame: 21 days). 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 5 Dec 2016.