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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Teva Pharmaceutical Industries
ClinicalTrials.gov Identifier:
NCT00837265
First received: February 4, 2009
Last updated: May 3, 2012
Last verified: May 2012
History of Changes
  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
 Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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:

U.S. FDA Resources

Further study details as provided by Teva Pharmaceutical Industries:

Primary Outcome Measures:
  • Duration of severe neutropenia [ Time Frame: Cycle 1 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Incidence of febrile neutropenia [ Time Frame: Cycles 1-4 ] [ Designated as safety issue: No ]
  • Duration of severe neutropenia in cycles 2-4, ANC recovery in cycles 1-4 [ Time Frame: cycles 2-4 and 1-4 ] [ Designated as safety issue: No ]

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
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
Active Comparator: Pegfilgrastim Drug: Pegfilgrastim
6mg

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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

No publications provided

Responsible Party: Teva Pharmaceutical Industries
ClinicalTrials.gov Identifier: NCT00837265     History of Changes
Other Study ID Numbers: NEUGR-002
Study First Received: February 4, 2009
Last Updated: May 3, 2012
Health Authority: Russia: Ministry of Health of the Russian Federation
Ukraine: State Pharmacological Center - Ministry of Health

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
 Doxorubicin
Docetaxel
Lenograstim
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on June 18, 2013