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

This study has been completed.
Sponsor:
Information provided by:
Amgen
ClinicalTrials.gov Identifier:
NCT00117117
First received: June 30, 2005
Last updated: March 24, 2009
Last verified: March 2009
  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
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
Study First Received: June 30, 2005
Last Updated: March 24, 2009
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Darbepoetin alfa
Hematinics
Hematologic Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 21, 2014