Chemotherapy-induced NeutropeniaPhase 3NEUGR-003NCT01126190
Neugranin in Breast Cancer Participants Receiving Doxorubicin/Docetaxel
A Phase 3 study testing Neugranin, Pegfilgrastim and Chemotherapy in people with Chemotherapy-induced Neutropenia, run by Teva Branded Pharmaceutical Products R&D, Inc. at 59 sites in 5 countries.
Trial summary
Determination of the effect of neugranin on the duration and severity of severe neutropenia in participants receiving doxorubicin in combination with docetaxel. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chemotherapy-induced Neutropenia
- What is being tested?
- Neugranin, Pegfilgrastim and Chemotherapy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 381 participants
- Where
- 59 sitesin 5 countries
- Study dates
- 30 Jun 2010to 29 Feb 2012
- Phase
- Phase 3
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Breast cancer participants scheduled to receive the AT regimen (doxorubicin/ docetaxel)
Who cannot join
- Participants may have received no more than 1 prior chemotherapy regimen (including adjuvant therapy if given within the last 12 months)
Trial locations and contacts
59 sites in 5 countries.
59 sites in 5 countries
Russia23 sites
Teva Investigational Site 0714
Arkhangelsk, 163045
Teva Investigational Site 0707
Chelyabinsk, 454087
Teva Investigational Site 0708
Ivanovo, 153013
Teva Investigational Site 0721
Kazan', 420029
Teva Investigational Site 0709
Krasnodar, 350040
Teva Investigational Site 0711
Kursk, 305035
Teva Investigational Site 0713
Leningrad Region, 188663
Teva Investigational Site 0710
Moscow, 121359
Teva Investigational Site 0703
Moscow, 129128
Teva Investigational Site 0716
Nizhny Novgorod, 603081
Teva Investigational Site 0720
Oryol, 302020
Teva Investigational Site 0724
Pyatigorsk, 357502
Teva Investigational Site 0725
Rostov-on-Don, 344037
Teva Investigational Site 0704
Saint Petersburg, 194017
Teva Investigational Site 0722
Saint Petersburg, 195067
Teva Investigational Site 0706
Saint Petersburg, 197758
Teva Investigational Site 0715
Saint Petersburg, 198255
Teva Investigational Site 0712
Samara, 443031
Teva Investigational Site 0723
Sochi, 354057
Teva Investigational Site 0717
Tambov, 392013
Teva Investigational Site 0719
Ufa, 450007
Teva Investigational Site 0705
Yaroslavl, 150040
Teva Investigational Site 0702
Yekaterinburg, 620036
Ukraine16 sites
Teva Investigational Site 3807
Chernihiv, 14029
Teva Investigational Site 3805
Chernivtsi, 58013
Teva Investigational Site 3802
Dnipropetrovsk, 49102
Teva Investigational Site 3811
Donetsk, 83092
Teva Investigational Site 3806
Ivano-Frankivsk, 76018
Teva Investigational Site 3814
Kharkiv, 61024
Teva Investigational Site 3804
Kharkiv, 61070
Teva Investigational Site 3816
Kharkiv, 61070
Teva Investigational Site 3803
Khmelnytskyi, 29009
Teva Investigational Site 3808
Kyiv, 03115
Teva Investigational Site 3817
Kyiv, 03115
Teva Investigational Site 3812
Lviv, 79031
Teva Investigational Site 3809
Mariupol, Donetsk Region, 87500
Teva Investigational Site 3801
Odesa, 65025
Teva Investigational Site 3815
Sumy, 40005
Teva Investigational Site 3810
Uzhhorod, 88014
Bulgaria8 sites
Teva Investigational Site 3502
Gabrovo, 5300
Teva Investigational Site 3511
Plovdiv, 4004
Teva Investigational Site 3504
Rousse, 7002
Teva Investigational Site 3501
Shumen, 9700
Teva Investigational Site 3506
Sofia District, 1233
Teva Investigational Site 3503
Stara Zagora, 6003
Teva Investigational Site 3505
Varna, 9010
Teva Investigational Site 3507
Veliko Tarnovo, 5000
Romania8 sites
Teva Investigational Site 4001
Baia Mare, Maramures County, 430031
Teva Investigational Site 4009
Brasov, 500366
Teva Investigational Site 4004
Bucharest, 020962
Teva Investigational Site 4002
Cluj-Napoca, 400015
Teva Investigational Site 4011
Cluj-Napoca, 999999
Teva Investigational Site 4005
Craiova, Dolj County, 200535
Teva Investigational Site 4010
Lasi County, 700106
Teva Investigational Site 4007
Timișoara, 300239
Serbia4 sites
Teva Investigational Site 8102
Belgrade, 11000
Teva Investigational Site 8103
Belgrade, 11000
Teva Investigational Site 8104
Kragujevac, 34000
Teva Investigational Site 8105
Niš, 18 000
About this study
Official title: A Randomized, Double-Blind, Active Comparator, Non-Inferiority Study of Subcutaneously Administered Neugranin (Recombinant Human Albumin-Human Granulocyte Colony Stimulating Factor) or Pegfilgrastim in Subjects With Breast Cancer Receiving Myelosuppressive Chemotherapy (Doxorubicin/Docetaxel), Followed by a Single-Arm, Open-Label Phase of Subcutaneously Administered Neugranin
Determination of the effect of neugranin on the duration and severity of severe neutropenia in participants receiving doxorubicin in combination with docetaxel.
- Conditions
- Chemotherapy-induced Neutropenia
- Being tested
- Neugranin, Pegfilgrastim, Chemotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NeugraninBiological
Also called Balugrastim
Neugranin will be administered per dose and schedule specified in the arm description.
PegfilgrastimBiological
Also called Neulasta
Pegfilgrastim will be administered per dose and schedule specified in the arm description.
ChemotherapyDrug
Also called Doxorubicin/Docetaxel
The chemotherapy regimen for this trial consists of doxorubicin 60 mg/m^2 and docetaxel 75 mg/m^2 in combination
| Study group | Role | What they receive |
|---|---|---|
| Double-Blind Phase: Pegfilgrastim | Active comparator | Participants will receive pegfilgrastim 6 milligrams (mg), administered by subcutaneous (SC) injection once per chemotherapy cycle (approximately 24 hours after chemotherapy administration) for up to 4 cycles (each cycle length = 21 days). The chemotherapy regimen consists of doxorubicin 60 mg/square meter (m^2) and docetaxel 75 mg/m^2 administered sequentially by intravenous (IV) infusion on Day 1 of treatment for up to four 21-day cycles. Receives: Biological: Pegfilgrastim; Drug: Chemotherapy |
| Double-Blind Phase: Neugranin 40 mg | Experimental | Participants will receive neugranin 40 mg, administered by SC injection once per chemotherapy cycle (approximately 24 hours after chemotherapy administration) for up to 4 cycles (each cycle length = 21 days). The chemotherapy regimen consists of doxorubicin 60 mg/m^2 and docetaxel 75 mg/m^2 administered sequentially by IV infusion on Day 1 of treatment for up to four 21-day cycles. Receives: Biological: Neugranin; Drug: Chemotherapy |
| Open-Label Phase: Neugranin 40 mg | Experimental | Participants will receive neugranin 40 mg, administered by SC injection once per chemotherapy cycle (approximately 24 hours after chemotherapy administration) for up to 4 cycles (each cycle length = 21 days). The chemotherapy regimen consists of doxorubicin 60 mg/m^2 and docetaxel 75 mg/m^2 administered sequentially by IV infusion on Day 1 of treatment for up to four 21-day cycles. Receives: Biological: Neugranin; Drug: Chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Double-Blind Phase: Duration of Severe Neutropenia in Cycle 1
Severe neutropenia was defined as Grade 4 neutropenia (absolute neutrophil count [ANC] <0.5 x 10^9/liter [L]). The duration of severe neutropenia was calculated by cycle as the number of days from the first day in which the ANC fell below 0.5 x 10^9/L after beginning a chemotherapy cycle until the participant had an ANC ≥0.5 x 10^9/L within the cycle.
Measured: Cycle 1 (cycle length = 21 days)
Open-Label Phase: Duration of Severe Neutropenia in Cycle 1
Severe neutropenia was defined as Grade 4 neutropenia (ANC <0.5 x 10^9/L). The duration of severe neutropenia was calculated by cycle as the number of days from the first day in which the ANC fell below 0.5 x 10^9/L after beginning a chemotherapy cycle until the participant had an ANC ≥0.5 x 10^9/L within the cycle. There was no planned statistical analysis for the open-label phase arm.
Measured: Cycle 1 (cycle length = 21 days)
Secondary outcomes (2)
Double-Blind Phase: Number of Participants With Febrile Neutropenia
Febrile neutropenia was defined as an imputed or observed ANC <0.5 x 10^9/L and body temperature >38.5 degrees celsius (°C) occurring on the same day and for more than one hour (axillary measurement). Number of participants with febrile neutropenia over all cycles (Cycles 1 to 4) has been reported.
Measured: Cycles 1-4 (each cycle = 21 days)
Open-Label Phase: Number of Participants With Febrile Neutropenia
Febrile neutropenia was defined as an imputed or observed ANC <0.5 x 10^9/L and body temperature >38.5 °C occurring on the same day and for more than one hour (axillary measurement). Number of participants with febrile neutropenia over all cycles (Cycles 1 to 4) has been reported.
Measured: Cycles 1-4 (each cycle = 21 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2010 (estimated)
- Study start30 Jun 2010
- Primary completion29 Feb 2012
- Study completion29 Feb 2012
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chemotherapy-induced NeutropeniaStudies 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 381 participants (actual)
Sponsor and investigators
- Lead sponsor
- Teva Branded Pharmaceutical Products R&D, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Teva Medical Expert, MD, Study director, Teva Branded Pharmaceutical Products R&D, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01126190
- Sponsor's protocol ID
- NEUGR-003
- Acronym
- NEUGR-003
- Status last verified
- Feb 2023
- First submitted
- 4 May 2010
- Last updated
- 28 Mar 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Volovat C, Gladkov OA, Bondarenko IM, Barash S, Buchner A, Bias P, Adar L, Avisar N. Efficacy and safety of balugrastim compared with pegfilgrastim in patients with breast cancer receiving chemotherapy. Clin Breast Cancer. 2014 Apr;14(2):101-8. doi: 10.1016/j.clbc.2013.10.001. Epub 2013 Oct 25.
PubMed 24485296
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Active Comparator, Non-Inferiority Study of Subcutaneously Administered Neugranin (Recombinant Human Albumin-Human Granulocyte Colony Stimulating Factor) or Pegfilgrastim in Subjects With Breast Cancer Receiving Myelosuppressive Chemotherapy (Doxorubicin/Docetaxel), Followed by a Single-Arm, Open-Label Phase of Subcutaneously Administered Neugranin
- ClinicalTrials.gov ID
- NCT01126190
- Acronym / sponsor ID
- NEUGR-003 / NEUGR-003
- Conditions
- Chemotherapy-induced Neutropenia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 381 participants (actual)
- Lead sponsor
- Teva Branded Pharmaceutical Products R&D, Inc.Industry (pharma, biotech, devices)
- Study start
- 30 Jun 2010 (actual)
- Primary completion
- 29 Feb 2012 (actual)
- Study completion
- 29 Feb 2012 (actual)
- First posted
- 19 May 2010 (estimated)
- Results
- Posted 28 Mar 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Determination of the effect of neugranin on the duration and severity of severe neutropenia in participants receiving doxorubicin in combination with docetaxel.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Double-Blind Phase: Pegfilgrastim | Active comparator | Biological: Pegfilgrastim, Drug: ChemotherapyParticipants will receive pegfilgrastim 6 milligrams (mg), administered by subcutaneous (SC) injection once per chemotherapy cycle (approximately 24 hours after chemotherapy administration) for up to 4 cycles (each cycle length = 21 days). The chemotherapy regimen consists of doxorubicin 60 mg/square meter (m^2) and docetaxel 75 mg/m^2 administered sequentially by intravenous (IV) infusion on Day 1 of treatment for up to four 21-day cycles. |
| Double-Blind Phase: Neugranin 40 mg | Experimental | Biological: Neugranin, Drug: ChemotherapyParticipants will receive neugranin 40 mg, administered by SC injection once per chemotherapy cycle (approximately 24 hours after chemotherapy administration) for up to 4 cycles (each cycle length = 21 days). The chemotherapy regimen consists of doxorubicin 60 mg/m^2 and docetaxel 75 mg/m^2 administered sequentially by IV infusion on Day 1 of treatment for up to four 21-day cycles. |
| Open-Label Phase: Neugranin 40 mg | Experimental | Biological: Neugranin, Drug: ChemotherapyParticipants will receive neugranin 40 mg, administered by SC injection once per chemotherapy cycle (approximately 24 hours after chemotherapy administration) for up to 4 cycles (each cycle length = 21 days). The chemotherapy regimen consists of doxorubicin 60 mg/m^2 and docetaxel 75 mg/m^2 administered sequentially by IV infusion on Day 1 of treatment for up to four 21-day cycles. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Breast cancer participants scheduled to receive the AT regimen (doxorubicin/ docetaxel)
Key exclusion criteria (1 listed)
- Participants may have received no more than 1 prior chemotherapy regimen (including adjuvant therapy if given within the last 12 months)
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 |
|---|---|---|
| NeugraninAlso: BalugrastimNeugranin will be administered per dose and schedule specified in the arm description. | Biological | Double-Blind Phase: Neugranin 40 mg, Open-Label Phase: Neugranin 40 mg |
| PegfilgrastimAlso: NeulastaPegfilgrastim will be administered per dose and schedule specified in the arm description. | Biological | Double-Blind Phase: Pegfilgrastim |
| ChemotherapyAlso: Doxorubicin/DocetaxelThe chemotherapy regimen for this trial consists of doxorubicin 60 mg/m^2 and docetaxel 75 mg/m^2 in combination | Drug | Double-Blind Phase: Neugranin 40 mg, Double-Blind Phase: Pegfilgrastim, Open-Label Phase: Neugranin 40 mg |
Primary outcome
Double-Blind Phase: Duration of Severe Neutropenia in Cycle 1
Time frame: Cycle 1 (cycle length = 21 days)
Severe neutropenia was defined as Grade 4 neutropenia (absolute neutrophil count [ANC] <0.5 x 10^9/liter [L]). The duration of severe neutropenia was calculated by cycle as the number of days from the first day in which the ANC fell below 0.5 x 10^9/L after beginning a chemotherapy cycle until the participant had an ANC ≥0.5 x 10^9/L within the cycle.
Open-Label Phase: Duration of Severe Neutropenia in Cycle 1
Time frame: Cycle 1 (cycle length = 21 days)
Severe neutropenia was defined as Grade 4 neutropenia (ANC <0.5 x 10^9/L). The duration of severe neutropenia was calculated by cycle as the number of days from the first day in which the ANC fell below 0.5 x 10^9/L after beginning a chemotherapy cycle until the participant had an ANC ≥0.5 x 10^9/L within the cycle. There was no planned statistical analysis for the open-label phase arm.
2 secondary outcomes
Double-Blind Phase: Number of Participants With Febrile Neutropenia
Time frame: Cycles 1-4 (each cycle = 21 days)
Open-Label Phase: Number of Participants With Febrile Neutropenia
Time frame: Cycles 1-4 (each cycle = 21 days)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 24485296Volovat C, Gladkov OA, Bondarenko IM, Barash S, Buchner A, Bias P, Adar L, Avisar N. Efficacy and safety of balugrastim compared with pegfilgrastim in patients with breast cancer receiving chemotherapy. Clin Breast Cancer. 2014 Apr;14(2):101-8. doi: 10.1016/j.clbc.2013.10.001. Epub 2013 Oct 25.
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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.
Teva Medical Expert, MD study director
Teva Branded Pharmaceutical Products R&D, Inc.
59 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Neugranin, Pegfilgrastim and Chemotherapy in people with Chemotherapy-induced Neutropenia, run by Teva Branded Pharmaceutical Products R&D, Inc. at 59 sites in 5 countries.
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 1 inclusion and 1 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 28 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 59 sites in Russia, Ukraine, Bulgaria, Romania, Serbia. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 28 Mar 2023). 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?
Double-Blind Phase: Duration of Severe Neutropenia in Cycle 1 (time frame: Cycle 1 (cycle length = 21 days)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01126190, which also lists 1 linked publication.
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 28 Mar 2023.