A Study of Darbepoetin Alfa in Anemic Subjects Not Receiving Chemotherapy Who Have Completed the 20010103 Study

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. Identifier: NCT00115167
Recruitment Status : Completed
First Posted : June 22, 2005
Last Update Posted : May 11, 2009
Information provided by:

June 21, 2005
June 22, 2005
May 11, 2009
August 2004
January 2007   (Final data collection date for primary outcome measure)
Incidence of adverse events [ Time Frame: throughout study ]
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Complete list of historical versions of study NCT00115167 on Archive Site
  • Confirmed antibody formation to investigational product [ Time Frame: throughout study ]
  • Deaths on study [ Time Frame: on study ]
  • Laboratory parameters [ Time Frame: throughout study ]
  • Vital signs (blood pressure) [ Time Frame: throughout study ]
  • Change in PRO scores [ Time Frame: from baseline to end of treatment ]
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A Study of Darbepoetin Alfa in Anemic Subjects Not Receiving Chemotherapy Who Have Completed the 20010103 Study
A Multicenter, Randomised, Double-Blind, Placebo-Controlled Roll Over Study to Protocol 20010103 of Darbepoetin Alfa for the Treatment of Anemia of Cancer
The purpose of this study is to determine the safety of darbepoetin alfa beyond 16 weeks of treatment in subjects with anemia of cancer who are not receiving chemotherapy.
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Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Anemia
  • Cancer
  • Drug: Placebo
  • Drug: Darbepoetin alfa
  • Experimental: Darbepoetin alfa
    Intervention: Drug: Darbepoetin alfa
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Smith RE Jr, Aapro MS, Ludwig H, Pintér T, Smakal M, Ciuleanu TE, Chen L, Lillie T, Glaspy JA. Darbepoetin alpha for the treatment of anemia in patients with active cancer not receiving chemotherapy or radiotherapy: results of a phase III, multicenter, randomized, double-blind, placebo-controlled study. J Clin Oncol. 2008 Mar 1;26(7):1040-50. doi: 10.1200/JCO.2007.14.2885. Epub 2008 Jan 28.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
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March 2007
January 2007   (Final data collection date for primary outcome measure)

Inclusion Criteria:

- Subjects completing the planned 16 weeks of treatment on the 20010103 Anemia of Cancer protocol

Exclusion Criteria:

  • Subjects currently receiving or planned to receive cytotoxic chemotherapy or myelosuppressive radiotherapy
  • Subjects who have other diagnoses not related to the cancer which can cause anemia
  • Known history of seizure disorder
  • Cardiac condition: uncontrolled angina, congestive heart failure, known ejection fraction less than 40%, or uncontrolled cardiac arrhythmia
  • Uncontrolled hypertension
  • Clinically significant systemic infection or chronic inflammatory disease present at the time of enrollment
  • Subject of reproductive potential who is not using adequate contraceptive precautions
  • Concerns for subject's compliance with the protocol procedures
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
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Italy,   Netherlands,   United States
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Global Development Leader, Amgen Inc.
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Study Director: MD Amgen
May 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP