Chemotherapy Related Anemia

Sponsor

Amgen (Industry)

Overall Status

Completed

CT.gov ID

NCT00035607

Collaborator

(none)

120

Enrollment

Arms

Duration (Months)

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
Anemia Non-Myeloid Malignancies	Drug: Darbepoetin alfa SC Drug: Darbepoetin alfa IV	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

120 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (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

Study Start Date :

Dec 1, 2001

Actual Primary Completion Date :

Dec 1, 2002

Actual Study Completion Date :

Apr 1, 2003

Arms and Interventions

Arm	Intervention/Treatment
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

Arm

Intervention/Treatment

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

Outcome Measures

Primary Outcome Measures

Change in hemoglobin concentration measured from baseline to the end of treatment period (EOTP) [from baseline to the end of treatment period (EOTP)]

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 [throughout study]
Change in hemoglobin concentration measured from baseline to week 7 and from week 7 to EOTP [from baseline to week 7 and from week 7 to EOTP]
Time to and percentage of subjects who achieve hemoglobin improvement during the treatment period [during the treatment period]
Time to and percentage of subjects with a hemoglobin response during the treatment period [during the treatment period]
Percentage of subjects who exceed the hemoglobin threshold [throughout study]
Incidence of all adverse events, serious adverse events, and severe or life-threatening adverse events [throughout study]
Incidence, if any, of neutralizing antibody formation to darbepoetin alfa [throughout study]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

No locations specified.

Sponsors and Collaborators

Amgen

Investigators

Study Director: MD, Amgen

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.

Responsible Party:

Amgen

ClinicalTrials.gov Identifier:

NCT00035607

Other Study ID Numbers:

20010199

First Posted:

May 6, 2002

Last Update Posted:

May 13, 2013

Last Verified:

May 1, 2013

Additional relevant MeSH terms:

Neoplasms

Anemia

Darbepoetin alfa

Study Results

No Results Posted as of May 13, 2013