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NCT00117117 Clinical Trial

A Study to Assess Symptom Burden in Subjects With Nonmyeloid Malignancies Receiving Chemotherapy and Aranesp®

Anemia Clinical Trial

Official title:
A Study to Assess Symptom Burden in Subjects With Nonmyeloid Malignancies Receiving Chemotherapy and Aranesp®

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00117117
Other study ID # 20020132
Secondary ID
Status Completed
Phase Phase 4
First received June 30, 2005
Last updated March 24, 2009
Start date September 2002
Est. completion date December 2003

Study information
Verified date March 2009
Source Amgen
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial 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®.

Recruitment information / eligibility
Status Completed
Enrollment 2423
Est. completion date December 2003
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Aranesp

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Amgen

References & Publications (2)

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 darbep — View 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. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Patient reported outcomes
Secondary Changes in hemoglobin endpoints and RBC transfusion requirements
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