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

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.
 
ClinicalTrials.gov Identifier: NCT00837265
Recruitment Status : Completed
First Posted : February 5, 2009
Last Update Posted : July 21, 2016
Sponsor:
Information provided by (Responsible Party):
Teva Pharmaceutical Industries

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

Condition or disease Intervention/treatment Phase
Chemotherapy-induced Neutropenia Biological: Neugranin Drug: Pegfilgrastim Drug: Chemotherapy Phase 2 Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 334 participants
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)
Study Start Date : August 2008
Actual Primary Completion Date : September 2009
Actual Study Completion Date : July 2010


Arm Intervention/treatment
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




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

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


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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).

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Responsible Party: Teva Pharmaceutical Industries
ClinicalTrials.gov Identifier: NCT00837265    
Other Study ID Numbers: NEUGR-002
First Posted: February 5, 2009    Key Record Dates
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:
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Neutropenia
Agranulocytosis
Leukopenia
Leukocyte Disorders
Hematologic Diseases
Docetaxel
Doxorubicin
Liposomal doxorubicin
Lenograstim
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Immunologic Factors
Physiological Effects of Drugs
Adjuvants, Immunologic