Chemotherapy Related Anemia

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Amgen
ClinicalTrials.gov Identifier:
NCT00035607
First received: May 3, 2002
Last updated: May 9, 2013
Last verified: May 2013
  Purpose

This study is investigating darbepoetin alfa for the treatment of anemia in patients with non-myeloid cancers who are receiving chemotherapy. Darbepoetin alfa is a recombinant protein that stimulates the production of red blood cells. In this study, darbepoetin alfa will be administered as either an injection under the skin (subcutaneously) or directly into a vein (intravenously).


Condition Intervention Phase
Anemia
Non-Myeloid Malignancies
Drug: Darbepoetin alfa SC
Drug: Darbepoetin alfa IV
Phase 2

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, Open-label, Multicenter Study of Subcutaneous and Intravenous Administration of Darbepoetin Alfa (Novel Erythropoiesis Stimulating Protein, NESP) for the Treatment of Anemia in Subjects With Non-myeloid Malignancies Receiving Multicycle Chemotherapy

Resource links provided by NLM:


Further study details as provided by Amgen:

Primary Outcome Measures:
  • Change in hemoglobin concentration measured from baseline to the end of treatment period (EOTP) [ Time Frame: from baseline to the end of treatment period (EOTP) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Percentage of subjects who have a rapid rise in hemoglobin concentration; negative clinical consequences potentially associated with this rise evaluated in subjects with and without a rapid rise in hemoglobin concentration [ Time Frame: throughout study ] [ Designated as safety issue: Yes ]
  • Change in hemoglobin concentration measured from baseline to week 7 and from week 7 to EOTP [ Time Frame: from baseline to week 7 and from week 7 to EOTP ] [ Designated as safety issue: No ]
  • Time to and percentage of subjects who achieve hemoglobin improvement during the treatment period [ Time Frame: during the treatment period ] [ Designated as safety issue: No ]
  • Time to and percentage of subjects with a hemoglobin response during the treatment period [ Time Frame: during the treatment period ] [ Designated as safety issue: No ]
  • Percentage of subjects who exceed the hemoglobin threshold [ Time Frame: throughout study ] [ Designated as safety issue: Yes ]
  • Incidence of all adverse events, serious adverse events, and severe or life-threatening adverse events [ Time Frame: throughout study ] [ Designated as safety issue: Yes ]
  • Incidence, if any, of neutralizing antibody formation to darbepoetin alfa [ Time Frame: throughout study ] [ Designated as safety issue: Yes ]

Enrollment: 120
Study Start Date: December 2001
Study Completion Date: April 2003
Primary Completion Date: December 2002 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Darbepoetin alfa SC Drug: Darbepoetin alfa SC
Subcutaneous (SC) injection of darbepoetin alfa at 4.5 mcg/kg weekly for weeks 1-6, then 4.5 mcg/kg Q3W
Experimental: Darbepoetin alfa IV Drug: Darbepoetin alfa IV
Intravenous administration of darbepoetin alfa at 4.5 mcg/kg weekly for weeks 1-6, then 4.5 mcg/kg Q3W

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosed with a non-myeloid malignancy
  • Scheduled to receive a minimum of an additional 12 weeks of chemotherapy from the time of first dose of study drug
  • Screening hemoglobin concentration less than or equal to 11.0g/dL
  • ECOG performance status of 0 to 2
  • Adequate renal and liver function

Exclusion Criteria:

  • History of seizure disorder
  • Received recombinant human erythropoietin (rHuEPO) or darbepoetin alfa therapy within 4 weeks before study day 1
  • More than 2 red blood cell transfusions within 4 weeks before study day 1, or any red blood cell transfusion within 14 days before study day 1
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00035607

Sponsors and Collaborators
Amgen
Investigators
Study Director: MD Amgen
  More Information

Additional Information:
Publications:
Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT00035607     History of Changes
Other Study ID Numbers: 20010199
Study First Received: May 3, 2002
Last Updated: May 9, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Anemia
Neoplasms
Hematologic Diseases
Darbepoetin alfa
Hematinics
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 17, 2014