A Study of Darbepoetin Alfa in Anemic Subjects Not Receiving Chemotherapy Who Have Completed the 20010103 Study
A Multicenter, Randomised, Double-Blind, Placebo-Controlled Roll Over Study to Protocol 20010103 of Darbepoetin Alfa for the Treatment of Anemia of Cancer
1 other identifier
interventional
371
0 countries
N/A
Brief Summary
The purpose of this study is to determine the safety of darbepoetin alfa beyond 16 weeks of treatment in subjects with anemia of cancer who are not receiving chemotherapy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Aug 2004
Typical duration for phase_3
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2004
CompletedFirst Submitted
Initial submission to the registry
June 21, 2005
CompletedFirst Posted
Study publicly available on registry
June 22, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2007
CompletedMay 11, 2009
May 1, 2009
2.4 years
June 21, 2005
May 7, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Incidence of adverse events
throughout study
Secondary Outcomes (5)
Confirmed antibody formation to investigational product
throughout study
Deaths on study
on study
Laboratory parameters
throughout study
Vital signs (blood pressure)
throughout study
Change in PRO scores
from baseline to end of treatment
Study Arms (2)
Darbepoetin alfa
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- \- Subjects completing the planned 16 weeks of treatment on the 20010103 Anemia of Cancer protocol
You may not qualify if:
- Subjects currently receiving or planned to receive cytotoxic chemotherapy or myelosuppressive radiotherapy
- Subjects who have other diagnoses not related to the cancer which can cause anemia
- Known history of seizure disorder
- Cardiac condition: uncontrolled angina, congestive heart failure, known ejection fraction less than 40%, or uncontrolled cardiac arrhythmia
- Uncontrolled hypertension
- Clinically significant systemic infection or chronic inflammatory disease present at the time of enrollment
- Subject of reproductive potential who is not using adequate contraceptive precautions
- Concerns for subject's compliance with the protocol procedures
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Amgenlead
Related Publications (1)
Smith RE Jr, Aapro MS, Ludwig H, Pinter T, Smakal M, Ciuleanu TE, Chen L, Lillie T, Glaspy JA. Darbepoetin alpha for the treatment of anemia in patients with active cancer not receiving chemotherapy or radiotherapy: results of a phase III, multicenter, randomized, double-blind, placebo-controlled study. J Clin Oncol. 2008 Mar 1;26(7):1040-50. doi: 10.1200/JCO.2007.14.2885. Epub 2008 Jan 28.
PMID: 18227526DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
MD
Amgen
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
June 21, 2005
First Posted
June 22, 2005
Study Start
August 1, 2004
Primary Completion
January 1, 2007
Study Completion
March 1, 2007
Last Updated
May 11, 2009
Record last verified: 2009-05