ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00117117
Recruitment Status : Completed
First Posted : July 4, 2005
Last Update Posted : March 25, 2009
Sponsor:
Information provided by:
Amgen

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®.

Condition or disease Intervention/treatment Phase
Anemia Drug: Aranesp Phase 4

Study Type : Interventional  (Clinical Trial)
Enrollment : 2423 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Study to Assess Symptom Burden in Subjects With Nonmyeloid Malignancies Receiving Chemotherapy and Aranesp®
Study Start Date : September 2002
Study Completion Date : December 2003

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anemia
U.S. FDA Resources




Primary Outcome Measures :
  1. Patient reported outcomes

Secondary Outcome Measures :
  1. Changes in hemoglobin endpoints and RBC transfusion requirements


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00117117


Sponsors and Collaborators
Amgen
Investigators
Study Director: MD Amgen