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Neugranin in Breast Cancer Patients Receiving Doxorubicin/Docetaxel (NEUGR-002)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00837265
First Posted: February 5, 2009
Last Update Posted: July 21, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Teva Pharmaceutical Industries
  Purpose
Determination of the effect of Neugranin on the duration and severity of severe neutropenia.

Condition Intervention Phase
Chemotherapy-induced Neutropenia Biological: Neugranin Drug: Pegfilgrastim Drug: Chemotherapy Phase 2 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
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)

Resource links provided by NLM:


Further study details as provided by Teva Pharmaceutical Industries:

Primary Outcome Measures:
  • Duration of severe neutropenia [ Time Frame: Cycle 1 ]

Secondary Outcome Measures:
  • Incidence of febrile neutropenia [ Time Frame: Cycles 1-4 ]
  • Duration of severe neutropenia in cycles 2-4, ANC recovery in cycles 1-4 [ Time Frame: cycles 2-4 and 1-4 ]

Enrollment: 334
Study Start Date: August 2008
Study Completion Date: July 2010
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Neugranin Dose Level 1 Biological: Neugranin
Neugranin (Recombinant Human Albumin-Human Granulocyte Colony Stimulating Factor)at two dose levels or comparator (pegfilgrastim 6 mg) administered approximately 24 hours following chemotherapy for 4 treatment cycles
Drug: Chemotherapy
study treatment was administered 24 hours after initiation of chemotherapy
Other Name: Doxorubicin/Docetaxel
Experimental: Neugranin Dose Level 2 Biological: Neugranin
Neugranin (Recombinant Human Albumin-Human Granulocyte Colony Stimulating Factor)at two dose levels or comparator (pegfilgrastim 6 mg) administered approximately 24 hours following chemotherapy for 4 treatment cycles
Drug: Chemotherapy
study treatment was administered 24 hours after initiation of chemotherapy
Other Name: Doxorubicin/Docetaxel
Active Comparator: Pegfilgrastim Drug: Pegfilgrastim
6mg
Drug: Chemotherapy
study treatment was administered 24 hours after initiation of chemotherapy
Other Name: Doxorubicin/Docetaxel

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).
  Contacts and Locations
No Contacts or Locations Provided
  More Information

Responsible Party: Teva Pharmaceutical Industries
ClinicalTrials.gov Identifier: NCT00837265     History of Changes
Other Study ID Numbers: NEUGR-002
First Submitted: February 4, 2009
First Posted: February 5, 2009
Last Update Posted: July 21, 2016
Last Verified: July 2016

Keywords provided by Teva Pharmaceutical Industries:
Breast Cancer Supportive Care Neutropenia

Additional relevant MeSH terms:
Breast Neoplasms
Neutropenia
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Agranulocytosis
Leukopenia
Leukocyte Disorders
Hematologic Diseases
Docetaxel
Liposomal doxorubicin
Doxorubicin
Lenograstim
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs