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Study of Darbepoetin Alfa for the Treatment of Anemia of Cancer

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ClinicalTrials.gov Identifier: NCT00091858
Recruitment Status : Completed
First Posted : September 21, 2004
Last Update Posted : May 8, 2013
Sponsor:
Information provided by (Responsible Party):
Amgen

Study Description
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Brief Summary:
The purpose of this study is to evaluate the efficacy of darbepoetin alfa versus placebo in reducing the occurrences of red blood cell transfusions in subjects with anemia of cancer who are not receiving chemotherapy.

Condition or disease Intervention/treatment Phase
Anemia Cancer Drug: Darbepoetin Alfa Drug: Placebo Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Enrollment : 1000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Multicenter, Randomized, Double-blind, Placebo-controlled Study of Darbepoetin Alfa for the Treatment of Anemia of Cancer
Study Start Date : April 2004
Actual Primary Completion Date : October 2006
Actual Study Completion Date : December 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anemia

Arms and Interventions
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Arm Intervention/treatment
Experimental: Darbepoetin alfa 6.75 mcg/kg Q4W Drug: Darbepoetin Alfa
6.75 mcg/kg Q4W
Placebo Comparator: Placebo Q4W Drug: Placebo
Placebo Q4W


Outcome Measures
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Primary Outcome Measures :
  1. Occurrences of red blood cell transfusion [ Time Frame: from study day 29 (week 5) to week 17 ]

Secondary Outcome Measures :
  1. Incidence of first red blood cell transfusion [ Time Frame: from week 5 (study day 29) to week 17 (study day 119) ]
  2. Change in hemoglobin concentration measured [ Time Frame: from baseline (study day 1) to EOTP ]
  3. Adverse events and serious adverse events [ Time Frame: throughout study for subjects who received at least 1 dose of investigational product ]
  4. Survival [ Time Frame: deaths on study and deaths in long-term follow-up period for subjects who received at least 1 dose of investigational product ]
  5. Incidence, if any, of neutralizing antibody formation to investigational product [ Time Frame: throughout study for subjects who received at least 1 dose of investigational product ]

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

Inclusion Criteria:

  • subjects with non-myeloid malignancies
  • anemia due to cancer
  • ECOG status 0 to 2
  • greater than or equal to 4-month expectancy
  • greater than or equal to 18 years and of legal age for informed consent
  • screening hemoglobin concentration less than or equal to 11.0g/dL
  • adequate serum folate and vitamin B12
  • adequate renal and liver function
  • written informed consent

Exclusion Criteria:

  • subjects currently receiving or planned to receive cytotoxic chemotherapy or myelosuppressive radiotherapy during the study or within 4 weeks before randomization
  • in complete remission, as determined by the investigator
  • subjects who have other diagnoses not related to the cancer which cause anemia (eg. gastrointestinal bleeding, renal disease, etc)
  • documented history of pure red cell aplasia
  • 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 randomization
  • iron deficiency
  • known positive test for HIV infection
  • previously suspected of or confirmed to have neutralizing antibodies to rHuEPO or darbepoetin alfa
  • received rHuEPO or darbepoetin alfa therapy within 4 weeks of randomization
  • less than 30 days since receipt of any investigational drug or device that is not approved by the applicable regulatory authority
  • pregnant or breast feeding
  • subject of reproductive potential who is not using adequate contraceptive precautions
  • known hypersensitivity to mammalian-derived product or any other ingredients in the investigational product
  • previously randomized into this study
  • concerns for subject's compliance with the protocol procedures
Contacts and Locations
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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): NCT00091858


Sponsors and Collaborators
Amgen
Investigators
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Study Director: MD Amgen
More Information
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Additional Information:

Publications of Results:

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Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT00091858    
Obsolete Identifiers: NCT00098696
Other Study ID Numbers: 20010103
First Posted: September 21, 2004    Key Record Dates
Last Update Posted: May 8, 2013
Last Verified: May 2013
Keywords provided by Amgen:
Cancer-related anemia
Additional relevant MeSH terms:
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Anemia
Hematologic Diseases
Darbepoetin alfa
Hematinics