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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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6 February 2023 |
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Main ID: |
NCT01126190 |
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Date of registration:
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04/05/2010 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Neugranin in Breast Cancer Participants Receiving Doxorubicin/Docetaxel
NEUGR-003 |
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Scientific title:
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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 |
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Date of first enrolment:
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June 30, 2010 |
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Target sample size:
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381 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT01126190 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Supportive Care. Masking: Triple (Participant, Investigator, Outcomes Assessor).
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Phase:
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Phase 3
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Countries of recruitment
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Bulgaria
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Romania
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Russian Federation
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Serbia
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Ukraine
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Contacts
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Name:
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Teva Medical Expert, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Teva Branded Pharmaceutical Products R&D, Inc. |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Breast cancer participants scheduled to receive the AT regimen (doxorubicin/
docetaxel)
Exclusion Criteria:
- Participants may have received no more than 1 prior chemotherapy regimen (including
adjuvant therapy if given within the last 12 months)
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Chemotherapy-induced Neutropenia
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Intervention(s)
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Biological: Pegfilgrastim
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Biological: Neugranin
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Drug: Chemotherapy
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Primary Outcome(s)
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Open-Label Phase: Duration of Severe Neutropenia in Cycle 1
[Time Frame: Cycle 1 (cycle length = 21 days)]
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Double-Blind Phase: Duration of Severe Neutropenia in Cycle 1
[Time Frame: Cycle 1 (cycle length = 21 days)]
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Secondary Outcome(s)
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Double-Blind Phase: Number of Participants with Febrile Neutropenia
[Time Frame: Cycles 1-4 (each cycle = 21 days)]
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Open-Label Phase: Number of Participants with Febrile Neutropenia
[Time Frame: Cycles 1-4 (each cycle = 21 days)]
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Secondary ID(s)
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NEUGR-003
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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