NCT00110955

Brief Summary

The purpose of this study is to compare the effect of darbepoetin alfa against placebo for the treatment of anemia in subjects with non-myeloid malignancies receiving multicycle chemotherapy.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
391

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Feb 2004

Shorter than P25 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

February 1, 2004

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2005

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2005

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 16, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 17, 2005

Completed
Last Updated

January 15, 2010

Status Verified

January 1, 2010

Enrollment Period

1.1 years

First QC Date

May 16, 2005

Last Update Submit

January 14, 2010

Conditions

AnemiaNon-Myeloid Malignancies

Keywords

Non-myeloid malignancyChemotherapy-induced anemia

Outcome Measures

Primary Outcomes (1)

  • Incidence of red blood cell (RBC) transfusion from week 5 to End of Treatment Period (EOTP)

    from week 5 to EOTP

Secondary Outcomes (13)

  • Incidence of achieving a hemoglobin concentration of greater than or equal to 11 g/dL in the absence of RBC transfusions in the preceding 28 days from week 5 to EOTP

    from week 5 to EOTP

  • Number of RBC transfusions from week 5 to EOTP

    from week 5 to EOTP

  • Change in FACT-Fatigue subscale score from baseline to EOTP

    from baseline to EOTP

  • Change in FACT-G Physical Well-being subscale from baseline to EOTP

    from baseline to EOTP

  • Incidence and severity of adverse events

    throughout study

  • +8 more secondary outcomes

Study Arms (2)

Darbepoetin alfa - Group A

EXPERIMENTAL
Drug: Darbepoetin alfa

Placebo- Group B

PLACEBO COMPARATOR
Drug: Placebo

Interventions

Darbepoetin alfaDRUG

Q3W 300 mcg darbepoetin alfa

Darbepoetin alfa - Group A
PlaceboDRUG

Q3W dosing of placebo

Placebo- Group B

Eligibility Criteria

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

You may qualify if:

  • Subjects with non-myeloid malignancy
  • At least 12 additional weeks of cyclic cytotoxic chemotherapy anticipated regardless of schedule
  • Hemoglobin concentration less than 11.0 g/dL within 24 hours before randomization
  • Adequate serum folate and vitamin B12
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
  • Of legal age at the time written informed consent is obtained

You may not qualify if:

  • Known history of seizure disorder
  • Known primary hematologic disorder causing anemia other than non-myeloid malignancies
  • Unstable/uncontrolled cardiac condition
  • Clinically significant inflammatory disease
  • Other diagnoses not related to the cancer which can cause anemia
  • Inadequate renal and liver function
  • Iron deficiency
  • Known positive test for HIV infection
  • Previously suspected of or confirmed to have neutralizing antibodies to rHuEPO
  • Received more than 2 red blood cell (RBC) transfusions within 4 weeks of randomization; or any RBC transfusion within 14 days before randomization; or any planned RBC transfusion between randomization and study day 1
  • Received any erythropoietic therapy within 4 weeks of study day 1 or any planned erythropoietic therapy between randomization and study day 1
  • Other investigational procedures
  • Currently enrolled in or has not yet completed at least 30 days since ending other investigational device or drug trial(s), or subject receiving other investigational agent(s)
  • Pregnant or breast feeding
  • Not using adequate contraceptive precautions
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Hernandez E, Ganly P, Charu V, Dibenedetto J, Tomita D, Lillie T, Taylor K; ARANESP 20030232 Study Group. Randomized, double-blind, placebo-controlled trial of every-3-week darbepoetin alfa 300 micrograms for treatment of chemotherapy-induced anemia. Curr Med Res Opin. 2009 Sep;25(9):2109-20. doi: 10.1185/03007990903084164.

    PMID: 19601709RESULT

Related Links

MeSH Terms

Conditions

Anemia

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

Study Record Dates

First Submitted

May 16, 2005

First Posted

May 17, 2005

Study Start

February 1, 2004

Primary Completion

March 1, 2005

Study Completion

April 1, 2005

Last Updated

January 15, 2010

Record last verified: 2010-01