A Study of AMG 114 Administered by Subcutaneous Injection for the Treatment of Anemia in Subjects With Non-Myeloid Malignancies Receiving Multicycle Chemotherapy
A Randomised, Multi-Center, Double-Blind, Placebo-Controlled, Dose-Finding Study of AMG 114 Administered by Subcutaneous Injection for the Treatment of Anemia in Subjects With Non-Myeloid Malignancies Receiving Multicycle Chemotherapy
1 other identifier
interventional
N/A
0 countries
N/A
Brief Summary
The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of AMG 114 administered subcutaneously for the treatment of chemotherapy induced anemia in subjects receiving multicycle chemotherapy.
Trial Health
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 6, 2005
CompletedFirst Posted
Study publicly available on registry
July 14, 2005
CompletedMay 11, 2009
May 1, 2009
July 6, 2005
May 7, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (5)
Incidence and severity of adverse events
Change in hemoglobin concentration
Maximum observed concentration (Cmax)
Time Cmax is observed (Tmax)
AUC
Secondary Outcomes (1)
Change in FACT-fatigue sub-scores
Interventions
Eligibility Criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Amgenlead
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
MD
Amgen
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
July 6, 2005
First Posted
July 14, 2005
Last Updated
May 11, 2009
Record last verified: 2009-05