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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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

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

Other trials in Russia

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

Other trials in Ukraine

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

Other trials in Bulgaria

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

Other trials in Romania

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

Other trials in Serbia

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.

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 groups in NCT01126190
Study groupRoleWhat they receive
Double-Blind Phase: PegfilgrastimActive comparatorParticipants 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 mgExperimentalParticipants 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 mgExperimentalParticipants 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.

  1. 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)

  2. 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)

  1. 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)

  2. 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.

  1. First posted19 May 2010 (estimated)
  2. Study start30 Jun 2010
  3. Primary completion29 Feb 2012
  4. Study completion29 Feb 2012

Resources

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)
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
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

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