Trials / Completed
CompletedNCT01126190
Neugranin in Breast Cancer Participants Receiving Doxorubicin/Docetaxel
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
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 381 (actual)
- Sponsor
- Teva Branded Pharmaceutical Products R&D, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
Determination of the effect of neugranin on the duration and severity of severe neutropenia in participants receiving doxorubicin in combination with docetaxel.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Neugranin | Neugranin will be administered per dose and schedule specified in the arm description. |
| BIOLOGICAL | Pegfilgrastim | Pegfilgrastim will be administered per dose and schedule specified in the arm description. |
| DRUG | Chemotherapy | The chemotherapy regimen for this trial consists of doxorubicin 60 mg/m\^2 and docetaxel 75 mg/m\^2 in combination |
Timeline
- Start date
- 2010-06-30
- Primary completion
- 2012-02-29
- Completion
- 2012-02-29
- First posted
- 2010-05-19
- Last updated
- 2023-03-28
- Results posted
- 2023-03-28
Locations
59 sites across 5 countries: Bulgaria, Romania, Russia, Serbia, Ukraine
Source: ClinicalTrials.gov record NCT01126190. Inclusion in this directory is not an endorsement.