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Neugranin in Breast Cancer Patients Receiving Doxorubicin/Docetaxel

Information source: Teva Pharmaceutical Industries
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Chemotherapy-induced Neutropenia

Intervention: Neugranin (Biological); Pegfilgrastim (Drug)

Phase: Phase 2/Phase 3

Status: Completed

Sponsored by: Teva Pharmaceutical Industries

Summary

Determination of the effect of Neugranin on the duration and severity of severe neutropenia.

Clinical Details

Official title: A Randomized 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)

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Primary outcome: Duration of severe neutropenia

Secondary outcome:

Incidence of febrile neutropenia

Duration of severe neutropenia in cycles 2-4, ANC recovery in cycles 1-4

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Breast cancer patients scheduled to receive the AT regimen (doxorubicin/ docetaxel).

Exclusion Criteria:

- Subjects may have received no more than 1 prior chemotherapy regimen (including

adjuvant therapy if given within the last 12 months).

Locations and Contacts

Additional Information

Starting date: August 2008
Last updated: August 27, 2013

Page last updated: August 23, 2015

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