Chemotherapy Related Anemia - Full Text View

Sponsor:	Amgen
Information provided by:	Amgen
ClinicalTrials.gov Identifier:	NCT00035607

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 II

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:

MedlinePlus related topics: Anemia Cancer

Drug Information available for: Darbepoetin alfa

U.S. FDA Resources

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:

AmgenTrials clinical trials website This link exits the ClinicalTrials.gov site

Notice regarding posted summaries of trial results This link exits the ClinicalTrials.gov site

To access clinical trial results information click on this link This link exits the ClinicalTrials.gov site

FDA-approved Drug Labeling This link exits the ClinicalTrials.gov site

Publications:

Justice G, Kessler JF, Jadeja J, Campos L, Weick J, Chen CF, Heatherington AC, Amado RG. A randomized, multicenter study of subcutaneous and intravenous darbepoetin alfa for the treatment of chemotherapy-induced anemia. Ann Oncol. 2005 Jul;16(7):1192-8. Epub 2005 Apr 28.

Responsible Party:	Global Development Leader, Amgen Inc.
ClinicalTrials.gov Identifier:	NCT00035607 History of Changes
Other Study ID Numbers:	20010199
Study First Received:	May 3, 2002
Last Updated:	September 11, 2008
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 February 12, 2012