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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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014