Chemotherapy Related Anemia

Anemia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00035607
• Other study ID #: 20010199
• Status: Completed
• Phase: Phase 2
• First received: May 3, 2002
• Last updated: May 9, 2013
• Start date: December 2001
• Est. completion date: April 2003

Study information

• Verified date: May 2013
• Source: Amgen
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: April 2003
• Est. primary completion date: December 2002
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Anemia
• Neoplasms
• Non-Myeloid Malignancies

Intervention

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
• Darbepoetin alfa IV
Intravenous administration of darbepoetin alfa at 4.5 mcg/kg weekly for weeks 1-6, then 4.5 mcg/kg Q3W

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Amgen

References & Publications (1)

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. E — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in hemoglobin concentration measured from baseline to the end of treatment period (EOTP)		from baseline to the end of treatment period (EOTP)	No
Secondary	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	Yes
Secondary	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	No
Secondary	Time to and percentage of subjects who achieve hemoglobin improvement during the treatment period		during the treatment period	No
Secondary	Time to and percentage of subjects with a hemoglobin response during the treatment period		during the treatment period	No
Secondary	Percentage of subjects who exceed the hemoglobin threshold		throughout study	Yes
Secondary	Incidence of all adverse events, serious adverse events, and severe or life-threatening adverse events		throughout study	Yes
Secondary	Incidence, if any, of neutralizing antibody formation to darbepoetin alfa		throughout study	Yes

External Links

•   AmgenTrials clinical trials website
•   FDA-approved Drug Labeling