AIM 3: Anemia and Iron Management With Every 3 Week Dosing in Anemic Subjects With Nonmyeloid Malignancies
A Randomized Open-Label Study of Darbepoetin Alfa Administered Every Three Weeks With or Without Parenteral Iron in Anemic Subjects With Nonmyeloid Malignancies Receiving Chemotherapy
1 other identifier
interventional
N/A
0 countries
N/A
Brief Summary
The study is designed to assess if the addition of intravenous (IV) iron to 500 mcg every 3 week (Q3W) darbepoetin alfa treatment enhances response as compared to the standard practice (oral iron or no iron administration).
Trial Health
Trial Health Score
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Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2004
CompletedFirst Submitted
Initial submission to the registry
August 24, 2005
CompletedFirst Posted
Study publicly available on registry
August 26, 2005
CompletedMay 23, 2013
May 1, 2013
August 24, 2005
May 21, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Proportion of subjects achieving a hematopoietic response (hemoglobin [hgb] greater than or equal to 12 g/dL or rise in hgb of greater than 2 g/dL) during the treatment period
Secondary Outcomes (9)
Time to hematopoietic response in days
The proportion of subjects with at least one red blood cell (RBC) transfusion from week 5 (day 29) to end of treatment period (EOTP)
Change in hemoglobin from baseline to EOTP
The proportion of subjects achieving a hemoglobin concentration greater than or equal to 11.0 g/dL, in the absence of RBC transfusions in the preceding 28 days, from week 5 to EOTP
The average hgb after achieving a hgb level greater than or equal to 11.0 g/dL
- +4 more secondary outcomes
Interventions
Eligibility Criteria
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Sponsors & Collaborators
- Amgenlead
Related Publications (1)
Bastit L, Vandebroek A, Altintas S, Gaede B, Pinter T, Suto TS, Mossman TW, Smith KE, Vansteenkiste JF. Randomized, multicenter, controlled trial comparing the efficacy and safety of darbepoetin alpha administered every 3 weeks with or without intravenous iron in patients with chemotherapy-induced anemia. J Clin Oncol. 2008 Apr 1;26(10):1611-8. doi: 10.1200/JCO.2006.10.4620.
PMID: 18375890RESULT
Related Links
MeSH Terms
Conditions
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
MD
Amgen
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 24, 2005
First Posted
August 26, 2005
Study Start
November 1, 2004
Last Updated
May 23, 2013
Record last verified: 2013-05