Back to resultsA Study of Darbepoetin Alfa in Anemic Subjects Not Receiving Chemotherapy Who Have Completed the 20010103 Study
Primary Purpose
Anemia, Cancer
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Placebo
Darbepoetin alfa
Sponsored by
About this trial
This is an interventional treatment trial for Anemia focused on measuring Oncology, Cancer-related anemia
Eligibility Criteria
Inclusion Criteria: - Subjects completing the planned 16 weeks of treatment on the 20010103 Anemia of Cancer protocol Exclusion Criteria: 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Darbepoetin alfa
Placebo
Arm Description
Outcomes
Primary Outcome Measures
Incidence of adverse events
Secondary Outcome Measures
Confirmed antibody formation to investigational product
Deaths on study
Laboratory parameters
Vital signs (blood pressure)
Change in PRO scores
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00115167
Brief Title
A Study of Darbepoetin Alfa in Anemic Subjects Not Receiving Chemotherapy Who Have Completed the 20010103 Study
Official Title
A Multicenter, Randomised, Double-Blind, Placebo-Controlled Roll Over Study to Protocol 20010103 of Darbepoetin Alfa for the Treatment of Anemia of Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
May 2009
Overall Recruitment Status
Completed
Study Start Date
August 2004 (undefined)
Primary Completion Date
January 2007 (Actual)
Study Completion Date
March 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Amgen
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anemia, Cancer
Keywords
Oncology, Cancer-related anemia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
371 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Darbepoetin alfa
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Q4W
Intervention Type
Drug
Intervention Name(s)
Darbepoetin alfa
Intervention Description
Q4W
Primary Outcome Measure Information:
Title
Incidence of adverse events
Time Frame
throughout study
Secondary Outcome Measure Information:
Title
Confirmed antibody formation to investigational product
Time Frame
throughout study
Title
Deaths on study
Time Frame
on study
Title
Laboratory parameters
Time Frame
throughout study
Title
Vital signs (blood pressure)
Time Frame
throughout study
Title
Change in PRO scores
Time Frame
from baseline to end of treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
- Subjects completing the planned 16 weeks of treatment on the 20010103 Anemia of Cancer protocol
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
MD
Organizational Affiliation
Amgen
Official's Role
Study Director
12. IPD Sharing Statement
Citations:
PubMed Identifier
18227526
Citation
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.
Results Reference
derived
Links:
URL
http://www.amgentrials.com
Description
AmgenTrials clinical trials website
URL
http://download.veritasmedicine.com/REGFILES/amgen/Amgen_results_disclaimer.pdf
Description
Notice regarding posted summaries of trial results
URL
http://download.veritasmedicine.com/REGFILES/amgen/08D_FDAMA_113_Posting_Summary_33_NESP_20020149.pdf
Description
To access clinical trial results information click on this link
URL
http://www.aranesp.com/
Description
FDA-approved Drug Labeling
Learn more about this trial
A Study of Darbepoetin Alfa in Anemic Subjects Not Receiving Chemotherapy Who Have Completed the 20010103 Study
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