NCT00111137

Brief Summary

The purpose of this study is to compare the time to hematopoietic response (hemoglobin correction to 12 g/dL or a greater than or equal to 2 g/dL increase from baseline) for subjects randomized to receive darbepoetin alfa with a front load dosing regimen to those receiving recombinant human erythropoietin (rHuEPO) with a weekly dose regimen during the 12-week comparative treatment period.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
718

participants targeted

Target at P75+ for phase_3 cancer

Timeline
Completed

Started Feb 2003

Shorter than P25 for phase_3 cancer

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, 2003

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2003

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2004

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

May 17, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 18, 2005

Completed
Last Updated

February 28, 2008

Status Verified

February 1, 2008

Enrollment Period

9 months

First QC Date

May 17, 2005

Last Update Submit

February 20, 2008

Conditions

CancerNon-Myeloid Malignancies

Keywords

darbepoetin alfaanemiaAmgenChemotherapy

Outcome Measures

Primary Outcomes (1)

  • Time to hematopoietic response during the comparative treatment period

    during the comparative treatment period

Secondary Outcomes (9)

  • Exploratory analyses for other patient reported outcome scales collected during the study (FACT-Anemia, BSI, EQ-5D, and Patient Satisfaction Questionnaire for Injectable Anemia Treatment)

    during the study

  • Incidence, if any, of neutralizing antibody formation to study drug

    throughout study

  • Difference between the average hemoglobin after the first month of treatment compared to the baseline hemoglobin

    baseline to first month of treatment

  • Time to 2 g/dL increase in hemoglobin during the comparative treatment period

    during the comparative treatment period

  • Change in FACT-Fatigue scale score over time during the comparative treatment period

    during the comparative treatment period

  • +4 more secondary outcomes

Study Arms (2)

rHuEPO

ACTIVE COMPARATOR
Drug: rHuEPO

Darbepoetin alfa

EXPERIMENTAL
Drug: Darbepoetin alfa

Interventions

rHuEPODRUG

rHuEPO 40,000U QW for 4 weeks. Dose will be increased to 60,000U/week at week 5 if inadequate response through week 12.

rHuEPO
Darbepoetin alfaDRUG

4.5 mcg/kg QW for 4 weeks then Q3W starting at week 5 through week 11.

Darbepoetin alfa

Eligibility Criteria

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

You may qualify if:

  • Subjects with non-myeloid malignancies planning to receive cyclic chemotherapy for 8 additional weeks or more
  • Anemia (hemoglobin \[hgb\] greater than or equal to 9.0g/dL and less than or equal to 11.0 g/dL) related to cancer and chemotherapy
  • Karnofsky performance status of greater than or equal to 50%
  • Serum bilirubin less than or equal to 2.5 times the upper limit of normal range and serum creatinine concentration of less than or equal to 2.0 mg/dL

You may not qualify if:

  • Acute myelogenous leukemia (AML), chronic myelogenous leukemia (CML), or myelodysplastic syndromes
  • Hematologic disorder previously associated with anemia
  • Active bleeding
  • Iron deficiency
  • Received erythropoietic therapy within 14 days prior to randomization
  • Unstable cardiac disease
  • Known positive human immunodeficiency virus antibody or hepatitis B surface antigen
  • Known positive antibody response to any erythropoietic agent
  • Currently enrolled in, or has not yet completed at least 30 days since ending other investigational device or drug trial or is receiving investigational agent(s) not approved for any indication
  • Pregnant or breast feeding
  • Red blood cell (RBC) transfusion within 4 weeks of screening
  • Known hypersensitivity to any recombinant mammalian-derived product

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Links

MeSH Terms

Conditions

NeoplasmsAnemia

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
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

May 17, 2005

First Posted

May 18, 2005

Study Start

February 1, 2003

Primary Completion

November 1, 2003

Study Completion

April 1, 2004

Last Updated

February 28, 2008

Record last verified: 2008-02