Back to resultsA Study to Assess Symptom Burden in Subjects With Nonmyeloid Malignancies Receiving Chemotherapy and Aranesp®
Primary Purpose
Anemia
Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Aranesp
Sponsored by
About this trial
This is an interventional treatment trial for Anemia focused on measuring Chemotherapy induced anemia, Amgen, Aranesp®, darbepoetin alfa
Eligibility Criteria
Inclusion Criteria: Subjects with nonmyeloid malignancy(ies) Anemia (hgb less than or equal to 11.0 g/dL) due to cancer and chemotherapy Exclusion Criteria: Subjects with acute myelogenous leukemia (AML), chronic myelogenous leukemia (CML), myelodysplastic syndromes (MDS) Unstable cardiac disease or anemia due to other causes
Sites / Locations
Outcomes
Primary Outcome Measures
Patient reported outcomes
Secondary Outcome Measures
Changes in hemoglobin endpoints and RBC transfusion requirements
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00117117
Brief Title
A Study to Assess Symptom Burden in Subjects With Nonmyeloid Malignancies Receiving Chemotherapy and Aranesp®
Official Title
A Study to Assess Symptom Burden in Subjects With Nonmyeloid Malignancies Receiving Chemotherapy and Aranesp®
Study Type
Interventional
2. Study Status
Record Verification Date
March 2009
Overall Recruitment Status
Completed
Study Start Date
September 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2003 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Amgen
4. Oversight
5. Study Description
Brief Summary
The purpose of this trial is to prospectively assess the relationship between changes in hemoglobin (hgb) and changes in symptom burden associated with anemia in cancer patients receiving chemotherapy supported with Aranesp®.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anemia
Keywords
Chemotherapy induced anemia, Amgen, Aranesp®, darbepoetin alfa
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
2423 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Aranesp
Primary Outcome Measure Information:
Title
Patient reported outcomes
Secondary Outcome Measure Information:
Title
Changes in hemoglobin endpoints and RBC transfusion requirements
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Subjects with nonmyeloid malignancy(ies)
Anemia (hgb less than or equal to 11.0 g/dL) due to cancer and chemotherapy
Exclusion Criteria:
Subjects with acute myelogenous leukemia (AML), chronic myelogenous leukemia (CML), myelodysplastic syndromes (MDS)
Unstable cardiac disease or anemia due to other causes
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
18632499
Citation
Gregory SA. Efficacy of Darbepoetin Alfa in the Treatment of Chemotherapy-Induced Anemia in Non-Hodgkin's Lymphoma. Support Cancer Ther. 2006 Jul 1;3(4):232-9. doi: 10.3816/SCT.2006.n.021.
Results Reference
result
PubMed Identifier
17694552
Citation
Gabrilove JL, Perez EA, Tomita DK, Rossi G, Cleeland CS. Assessing symptom burden using the M. D. Anderson symptom inventory in patients with chemotherapy-induced anemia: results of a multicenter, open-label study (SURPASS) of patients treated with darbepoetin-alpha at a dose of 200 microg every 2 weeks. Cancer. 2007 Oct 1;110(7):1629-40. doi: 10.1002/cncr.22943.
Results Reference
result
Links:
URL
http://www.amgentrials.com
Description
AmgenTrials clinical trials website
Learn more about this trial
A Study to Assess Symptom Burden in Subjects With Nonmyeloid Malignancies Receiving Chemotherapy and Aranesp®
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