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NCT00095277 Clinical Trial

Darbepoetin Alfa Administered Once Every 4 Weeks in the Treatment of Subjects With Anemia of Cancer

Anemia Clinical Trial

Official title:
A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study of Darbepoetin Alfa Administered Once Every 4 Weeks in the Treatment of Subjects With Anemia of Cancer

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00095277
Other study ID # 20030204
Secondary ID
Status Completed
Phase Phase 2
First received November 2, 2004
Last updated March 12, 2009
Start date October 2004

Study information
Verified date March 2009
Source Amgen
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

The purpose of this trial is to demonstrate benefit with respect to hematopoietic response in subjects with anemia of cancer randomized to Darbepoetin Alfa once every 4 weeks.

Recruitment information / eligibility
Status Completed
Enrollment 220
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Eligibility Criteria: - Subjects with non-myeloid malignancies - Subjects can not be on chemotherapy - Anemia of cancer - Eastern Cooperative Oncology Group (ECOG) status of 0 to 2 - Hemoglobin less than or equal to 11.0 g/dL - Adequate renal and liver function - Written informed consent

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Darbepoetin Alfa

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Amgen

References & Publications (1)

Gordon D, Nichols G, Ben-Jacob A, Tomita D, Lillie T, Miller C. Treating anemia of cancer with every-4-week darbepoetin alfa: final efficacy and safety results from a phase II, randomized, double-blind, placebo-controlled study. Oncologist. 2008 Jun;13(6) — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary To demonstrate benefit with respect to hematopoietic response in subjects with anemia of cancer randomized to darbepoetin alfa once every 4 weeks.
Secondary Assess efficacy
Secondary Assess PROs
Secondary Assess relationship between PROs and hemoglobin concentration
Secondary Assess safety of dose and frequency
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