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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00117117
First Posted: July 4, 2005
Last Update Posted: March 25, 2009
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.
Information provided by:
Amgen
  Purpose
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 Intervention Phase
Anemia Drug: Aranesp Phase 4

Study Type: Interventional
Study Design: 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®

Resource links provided by NLM:


Further study details as provided by Amgen:

Primary Outcome Measures:
  • Patient reported outcomes

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

Estimated Enrollment: 2423
Study Start Date: September 2002
Estimated Study Completion Date: December 2003
  Eligibility

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
  Contacts and Locations
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
  More Information

Additional Information:
Publications:
Responsible Party: Global Development Leader, Amgen Inc.
ClinicalTrials.gov Identifier: NCT00117117     History of Changes
Other Study ID Numbers: 20020132
First Submitted: June 30, 2005
First Posted: July 4, 2005
Last Update Posted: March 25, 2009
Last Verified: March 2009

Keywords provided by Amgen:
Chemotherapy induced anemia
Amgen
Aranesp®
darbepoetin alfa

Additional relevant MeSH terms:
Darbepoetin alfa
Hematinics