Treatment of Anemia in Subjects With Non-Myeloid Malignancy Receiving Multicycle Chemotherapy

This study has been completed.
Sponsor:
Information provided by:
Amgen
ClinicalTrials.gov Identifier:
NCT00110955
First received: May 16, 2005
Last updated: January 14, 2010
Last verified: January 2010
  Purpose

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.


Condition Intervention Phase
Anemia
Non-Myeloid Malignancies
Drug: Darbepoetin alfa
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo-Controlled Study of Darbepoetin Alfa for the Treatment of Anemia in Subjects With Non-Myeloid Malignancy Receiving Multicycle Chemotherapy

Resource links provided by NLM:


Further study details as provided by Amgen:

Primary Outcome Measures:
  • Incidence of red blood cell (RBC) transfusion from week 5 to End of Treatment Period (EOTP) [ Time Frame: from week 5 to EOTP ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 [ Time Frame: from week 5 to EOTP ] [ Designated as safety issue: No ]
  • Number of RBC transfusions from week 5 to EOTP [ Time Frame: from week 5 to EOTP ] [ Designated as safety issue: No ]
  • Change in FACT-Fatigue subscale score from baseline to EOTP [ Time Frame: from baseline to EOTP ] [ Designated as safety issue: No ]
  • Change in FACT-G Physical Well-being subscale from baseline to EOTP [ Time Frame: from baseline to EOTP ] [ Designated as safety issue: No ]
  • Incidence and severity of adverse events [ Time Frame: throughout study ] [ Designated as safety issue: Yes ]
  • Incidence of hemoglobin concentration greater than 13.0 g/dL at any time on study [ Time Frame: at any time on study ] [ Designated as safety issue: Yes ]
  • Change in FACT-G total score from baseline to EOTP [ Time Frame: from baseline to EOTP ] [ Designated as safety issue: No ]
  • Incidence of an increase in hemoglobin concentration greater than or equal to 2 g/dL in a 28-day window and any negative clinical consequences [ Time Frame: throughout study ] [ Designated as safety issue: Yes ]
  • Change in EQ-5D Thermometer from baseline to EOTP [ Time Frame: from baseline to EOTP ] [ Designated as safety issue: No ]
  • Change in BSI Anxiety scale score from baseline to EOTP [ Time Frame: from baseline to EOTP ] [ Designated as safety issue: No ]
  • Change in BSI Depression scale score from baseline to EOTP [ Time Frame: from baseline to EOTP ] [ Designated as safety issue: No ]
  • Change in number of caregiver hours from baseline to EOTP [ Time Frame: from baseline to EOTP ] [ Designated as safety issue: No ]
  • Incidence of a confirmed antibody formation to darbepoetin alfa [ Time Frame: throughout study ] [ Designated as safety issue: Yes ]

Enrollment: 391
Study Start Date: February 2004
Study Completion Date: April 2005
Primary Completion Date: March 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Darbepoetin alfa - Group A Drug: Darbepoetin alfa
Q3W 300 mcg darbepoetin alfa
Placebo Comparator: Placebo- Group B Drug: Placebo
Q3W dosing of placebo

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • Previously randomized into this study
  • Known hypersensitivity to any products to be administered
  • Concerns for subject's compliance
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00110955

Sponsors and Collaborators
Amgen
Investigators
Study Director: MD Amgen
  More Information

Additional Information:
Publications:
Responsible Party: Global Development Leader, Amgen Inc.
ClinicalTrials.gov Identifier: NCT00110955     History of Changes
Other Study ID Numbers: 20030232
Study First Received: May 16, 2005
Last Updated: January 14, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Amgen:
Non-myeloid malignancy
Chemotherapy-induced anemia

Additional relevant MeSH terms:
Anemia
Neoplasms
Hematologic Diseases
Darbepoetin alfa
Hematinics
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 21, 2014