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

Sponsored by:	Amgen
Information provided by:	Amgen
ClinicalTrials.gov Identifier:	NCT00110955

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 III

MedlinePlus related topics: Anemia Blood Transfusion and Donation Cancer

Drug Information available for: Darbepoetin alfa

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study
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

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 ]
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 ]
Change in FACT-G total score from baseline to EOTP [ Time Frame: from baseline to EOTP ] [ Designated as safety issue: No ]
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 ]
Number of RBC transfusions from week 5 to EOTP [ Time Frame: from week 5 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 ]
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 ]
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
Darbepoetin alfa - Group A: Experimental	Drug: Darbepoetin alfa Q3W 300 mcg darbepoetin alfa
Placebo- Group B: Placebo Comparator	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

AmgenTrials clinical trials website This link exits the ClinicalTrials.gov site

Notice regarding posted summaries of trial results This link exits the ClinicalTrials.gov site

To access clinical trial results information click on this link This link exits the ClinicalTrials.gov site

Responsible Party:	Amgen Inc. ( Global Development Leader )
Study ID Numbers:	20030232
Study First Received:	May 16, 2005
Last Updated:	February 20, 2008
ClinicalTrials.gov Identifier:	NCT00110955
Health Authority:	United States: Food and Drug Administration

Keywords provided by Amgen:

Non-myeloid malignancy
Chemotherapy-induced anemia

Study placed in the following topic categories:

Hematologic Diseases
Darbepoetin alfa
Anemia

Additional relevant MeSH terms:

Neoplasms
Hematinics
Therapeutic Uses
Hematologic Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009