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Study of Darbepoetin Alfa for the Treatment of Anemia of Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Amgen
ClinicalTrials.gov Identifier:
NCT00091858
First received: September 17, 2004
Last updated: May 6, 2013
Last verified: May 2013

September 17, 2004
May 6, 2013
April 2004
October 2006   (final data collection date for primary outcome measure)
Occurrences of red blood cell transfusion [ Time Frame: from study day 29 (week 5) to week 17 ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00091858 on ClinicalTrials.gov Archive Site
  • Incidence of first red blood cell transfusion [ Time Frame: from week 5 (study day 29) to week 17 (study day 119) ] [ Designated as safety issue: No ]
  • Change in hemoglobin concentration measured [ Time Frame: from baseline (study day 1) to EOTP ] [ Designated as safety issue: No ]
  • Adverse events and serious adverse events [ Time Frame: throughout study for subjects who received at least 1 dose of investigational product ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
Not Provided
 
Study of Darbepoetin Alfa for the Treatment of Anemia of Cancer
A Multicenter, Randomized, Double-blind, Placebo-controlled Study of Darbepoetin Alfa for the Treatment of Anemia of Cancer

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Anemia
  • Cancer
  • Drug: Darbepoetin Alfa
    6.75 mcg/kg Q4W
  • Drug: Placebo
    Placebo Q4W
  • Experimental: Darbepoetin alfa 6.75 mcg/kg Q4W
    Intervention: Drug: Darbepoetin Alfa
  • Placebo Comparator: Placebo Q4W
    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. Epub 2008 Jan 28.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1000
December 2006
October 2006   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00091858
20010103
Not Provided
Amgen
Amgen
Not Provided
Study Director: MD Amgen
Amgen
May 2013

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