Darbepoetin Alfa Administered Once Every 4 Weeks in the Treatment of Subjects With Anemia of Cancer

This study has been completed.

Sponsor:

Information provided by:

Amgen

ClinicalTrials.gov Identifier:

NCT00095277

First received: November 2, 2004

Last updated: March 12, 2009

Last verified: March 2009

History of Changes

Purpose

The purpose of this trial is to demonstrate benefit with respect to hematopoietic response in subjects with anemia of cancer randomized to Darbepoetin Alfa once every 4 weeks.

Condition	Intervention	Phase
Anemia	Drug: Darbepoetin Alfa	Phase 2


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment
Official Title:	A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study of Darbepoetin Alfa Administered Once Every 4 Weeks in the Treatment of Subjects With Anemia of Cancer

Resource links provided by NLM:

MedlinePlus related topics: Anemia

Drug Information available for: Darbepoetin Alfa

Genetic and Rare Diseases Information Center resources: Multiple Myeloma

U.S. FDA Resources

Further study details as provided by Amgen:

Primary Outcome Measures:

To demonstrate benefit with respect to hematopoietic response in subjects with anemia of cancer randomized to darbepoetin alfa once every 4 weeks.

Secondary Outcome Measures:

Assess efficacy
Assess PROs
Assess relationship between PROs and hemoglobin concentration
Assess safety of dose and frequency


Estimated Enrollment:	220
Study Start Date:	October 2004

Eligibility


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

Criteria

Eligibility Criteria: - Subjects with non-myeloid malignancies - Subjects can not be on chemotherapy - Anemia of cancer - Eastern Cooperative Oncology Group (ECOG) status of 0 to 2 - Hemoglobin less than or equal to 11.0 g/dL - Adequate renal and liver function - Written informed consent

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: NCT00095277

Sponsors and Collaborators

Amgen

Investigators


Study Director:	MD	Amgen

More Information

Additional Information:

AmgenTrials clinical trials website This link exits the ClinicalTrials.gov site

FDA-approved Drug Labeling This link exits the ClinicalTrials.gov site

Publications:

Gordon D, Nichols G, Ben-Jacob A, Tomita D, Lillie T, Miller C. Treating anemia of cancer with every-4-week darbepoetin alfa: final efficacy and safety results from a phase II, randomized, double-blind, placebo-controlled study. Oncologist. 2008 Jun;13(6):715-24. doi: 10.1634/theoncologist.2007-0241.


Responsible Party:	Global Development Leader, Amgen Inc.
ClinicalTrials.gov Identifier:	NCT00095277 History of Changes
Other Study ID Numbers:	20030204
Study First Received:	November 2, 2004
Last Updated:	March 12, 2009
Health Authority:	United States: Food and Drug Administration

Keywords provided by Amgen:


non-myeloid malignancies myeloma Anemia of Cancer

Additional relevant MeSH terms:


Anemia Hematologic Diseases Darbepoetin alfa Hematinics

ClinicalTrials.gov processed this record on September 23, 2016

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