NCT00091858

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,000

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Apr 2004

Typical duration for phase_3

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2004

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

September 17, 2004

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 21, 2004

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2006

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2006

Completed
Last Updated

May 8, 2013

Status Verified

May 1, 2013

Enrollment Period

2.5 years

First QC Date

September 17, 2004

Last Update Submit

May 6, 2013

Conditions

AnemiaCancer

Keywords

Cancer-related anemia

Outcome Measures

Primary Outcomes (1)

  • Occurrences of red blood cell transfusion

    from study day 29 (week 5) to week 17

Secondary Outcomes (5)

  • Incidence of first red blood cell transfusion

    from week 5 (study day 29) to week 17 (study day 119)

  • Change in hemoglobin concentration measured

    from baseline (study day 1) to EOTP

  • Adverse events and serious adverse events

    throughout study for subjects who received at least 1 dose of investigational product

  • Survival

    deaths on study and deaths in long-term follow-up period for subjects who received at least 1 dose of investigational product

  • Incidence, if any, of neutralizing antibody formation to investigational product

    throughout study for subjects who received at least 1 dose of investigational product

Study Arms (2)

Darbepoetin alfa 6.75 mcg/kg Q4W

EXPERIMENTAL
Drug: Darbepoetin Alfa

Placebo Q4W

PLACEBO COMPARATOR
Drug: Placebo

Interventions

Darbepoetin AlfaDRUG

6.75 mcg/kg Q4W

Darbepoetin alfa 6.75 mcg/kg Q4W
PlaceboDRUG

Placebo Q4W

Placebo Q4W

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Smith RE Jr, Aapro MS, Ludwig H, Pinter 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.

    PMID: 18227526RESULT

Related Links

MeSH Terms

Conditions

AnemiaNeoplasms

Interventions

Darbepoetin alfa

Condition Hierarchy (Ancestors)

Hematologic DiseasesHemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

ErythropoietinColony-Stimulating FactorsGlycoproteinsGlycoconjugatesCarbohydratesProteinsAmino Acids, Peptides, and Proteins

Study Officials

  • MD

    Amgen

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 17, 2004

First Posted

September 21, 2004

Study Start

April 1, 2004

Primary Completion

October 1, 2006

Study Completion

December 1, 2006

Last Updated

May 8, 2013

Record last verified: 2013-05