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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00117117

Enrollment

2423

Registered

2005-07-04

Start date

2002-09-30

Completion date

2003-12-31

Last updated

2009-03-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anemia

Keywords

Chemotherapy induced anemia, Amgen, Aranesp®, darbepoetin alfa

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®.

Interventions

DRUGAranesp

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Patient reported outcomes	—

Secondary

Measure	Time frame
Changes in hemoglobin endpoints and RBC transfusion requirements	—

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026