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

This study has been completed.
Sponsor:
Information provided by:
Amgen
ClinicalTrials.gov Identifier:
NCT00115167
First received: June 21, 2005
Last updated: May 7, 2009
Last verified: May 2009

June 21, 2005
May 7, 2009
August 2004
January 2007   (final data collection date for primary outcome measure)
Incidence of adverse events [ Time Frame: throughout study ] [ Designated as safety issue: Yes ]
Not Provided
Complete list of historical versions of study NCT00115167 on ClinicalTrials.gov Archive Site
  • Confirmed antibody formation to investigational product [ Time Frame: throughout study ] [ Designated as safety issue: Yes ]
  • Deaths on study [ Time Frame: on study ] [ Designated as safety issue: Yes ]
  • Laboratory parameters [ Time Frame: throughout study ] [ Designated as safety issue: Yes ]
  • Vital signs (blood pressure) [ Time Frame: throughout study ] [ Designated as safety issue: Yes ]
  • Change in PRO scores [ Time Frame: from baseline to end of treatment ] [ Designated as safety issue: No ]
Not Provided
Not Provided
Not Provided
 
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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Anemia
  • Cancer
  • Drug: Placebo
    Q4W
  • Drug: Darbepoetin alfa
    Q4W
  • 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. 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
371
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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00115167
20020149
Not Provided
Global Development Leader, Amgen Inc.
Amgen
Not Provided
Study Director: MD Amgen
Amgen
May 2009

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