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

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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

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 ]


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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).

Responsible Party: Teva Pharmaceutical Industries
ClinicalTrials.gov Identifier: NCT00837265     History of Changes
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:
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