Chemotherapy Related Anemia

NCT00035607 | Completed Phase 2

• 1 other identifier: 20010199
• Study Type: interventional
• Target: 120
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Anemia; Non-Myeloid Malignancies

Outcome Measures

Primary Outcomes (1)

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

  from baseline to the end of treatment period (EOTP)

Secondary Outcomes (7)

• 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

Study Arms (2)

Darbepoetin alfa SC

ACTIVE COMPARATOR

Drug: Darbepoetin alfa SC

Darbepoetin alfa IV

EXPERIMENTAL

Drug: Darbepoetin alfa IV

Interventions

Darbepoetin alfa SC DRUG

Subcutaneous (SC) injection of darbepoetin alfa at 4.5 mcg/kg weekly for weeks 1-6, then 4.5 mcg/kg Q3W

Darbepoetin alfa SC

Darbepoetin alfa IV DRUG

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

Darbepoetin alfa IV

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Amgen: lead

Related 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. doi: 10.1093/annonc/mdi218. Epub 2005 Apr 28.

  PMID: 15860486 RESULT

Related Links

• AmgenTrials clinical trials website
• Notice regarding posted summaries of trial results
• To access clinical trial results information click on this link
• FDA-approved Drug Labeling

MeSH Terms

Conditions

Anemia

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• MD

  Amgen

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 3, 2002
• First Posted: May 6, 2002
• Study Start: December 1, 2001
• Primary Completion: December 1, 2002
• Study Completion: April 1, 2003
• Last Updated: May 13, 2013

Record last verified: 2013-05