A Study of Darbepoetin Alfa for the 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:	NCT00118638

Purpose

The purpose of this study is to evaluate the efficacy of darbepoetin alfa as 500ug once every 3 weeks to show that the dose and schedule are not inferior to darbepoetin alfa administered as 2.25ug/kg once per week in the treatment of anemia in subjects with non-myeloid malignancies.

Condition	Intervention	Phase
Anemia Non-Myeloid Malignancies	Drug: Darbepoetin alfa - 2.25 mcg/kg Drug: Darbepoetin alfa - 500mcg	Phase III

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, Active-Controlled Study of Darbepoetin Alfa for the Treatment of Anemia in Subjects With Non-Myeloid Malignancy Receiving Multicycle Chemotherapy

Resource links provided by NLM:

MedlinePlus related topics: Anemia Blood Transfusion and Donation Cancer

Drug Information available for: Darbepoetin alfa

U.S. FDA Resources

Further study details as provided by Amgen:

Primary Outcome Measures:

Incidence of at least one 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 greater than or equal to 11.0 g/dL, in the absence of RBC transfusions in the preceding 28 days, from week 1 to EOTP [ Time Frame: from week 1 to EOTP ] [ Designated as safety issue: No ]
Change in hemoglobin from baseline to EOTP [ Time Frame: from baseline 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 ]
Incidence of achieving a hemoglobin concentration of greater than or equal to 11.0 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 ]
Incidence of at least one RBC transfusion from week 1 (day 1) to EOTP [ Time Frame: from week 1 (day 1) 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 ]
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 number of caregiver hours 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 ]
Incidence of an increase in hemoglobin concentration of greater than or equal to 1 g/dL in a 14-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:	705
Study Start Date:	March 2004
Study Completion Date:	January 2005
Primary Completion Date:	December 2004 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Darbepoetin alfa 500 mcg - Group A: Experimental	Drug: Darbepoetin alfa - 500mcg Darbepoetin alfa 500mcg Q3W dosing / placebo QW
Darbepoetin alfa 2.25 mcg/kg - Group B: Active Comparator	Drug: Darbepoetin alfa - 2.25 mcg/kg Darbepoetin alfa 2.25 mcg/kg QW dosing/ placebo Q3W

Eligibility

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

Criteria

Inclusion Criteria:

Non-myeloid malignancy
At least 12 additional weeks of cyclic cytotoxic chemotherapy anticipated regardless of schedule
Eastern Cooperative Oncology Group performance status of 0-2
Hemoglobin concentration of less than 11 g/dL within 24 hours before randomization
Of legal age at the time written informed consent is obtained

Exclusion Criteria:

Known history of seizure disorder
Known primary hematologic disorder, which could cause anemia, other than a non-myeloid malignancy
Unstable or uncontrolled disease/condition, related to or affecting cardiac function
Clinically significant inflammatory disease
Inadequate renal and/or liver function
Known positive HIV test
Previously suspected of or confirmed to have neutralizing antibodies to rHuEPO
Received more than 2 red blood cell (RBC) transfusions within 4 weeks before 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 before randomization or any planned erythropoietic therapy between randomization and study day 1
Other investigational procedures
Subject is currently enrolled in or 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
Not using adequate contraceptive precautions
Known sensitivity to any of the products to be administered during dosing
Previously randomized in this study
Concerns for subject's compliance with protocol procedures

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00118638

Sponsors and Collaborators

Amgen

Investigators

Study Director:

MD

Amgen

More Information

Additional Information:

Clinical Study Results website - Results posting for study 20030231 This link exits the ClinicalTrials.gov site

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

Publications:

Canon JL, Vansteenkiste J, Bodoky G, Mateos MV, Bastit L, Ferreira I, Rossi G, Amado RG. Randomized, double-blind, active-controlled trial of every-3-week darbepoetin alfa for the treatment of chemotherapy-induced anemia. J Natl Cancer Inst. 2006 Feb 15;98(4):273-84.

Responsible Party:	Amgen Inc. ( Global Development Leader )
Study ID Numbers:	20030231
Study First Received:	June 30, 2005
Last Updated:	March 24, 2009
ClinicalTrials.gov Identifier:	NCT00118638 History of Changes
Health Authority:	Austria: Bundesamt für Sicherheit im Gesundheitswesen; Belgium: Service Public Federal Sante Publiquest, Securite de la Chaine alimentaire et Environnement; Bulgaria: Ministry of Health; Czech Republic: Statni ustav pro kontrolu leciv; Denmark: Laegemiddelstyrelsen; Estonia: State Agency of Medicines; Finland: Lääkelaitos; United Kingdom: Medicines and Healthcare Products Regulatory Agency; France: Afssaps - French Health Products Safety Agency; Germany: Paul_Ehrlich-Institut Bundesamt fur Sera und Impfstoffe; Hungary: National Institute of Pharmacy; Italy: Local Ethics Committees; Latvia: State Agency of Medicines; Lithuania: State Medicines Control Agency of Lithuania; Netherlands: Medisch Centrum Rijnmond_Zuid, lcatie Zuider; Norway: Norwegian Medicines Agency; Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products; Portugal: Instituto Nacional da Farmácia e do Medicamento (INFARMED); Romania: Ministry of Health and the Family; Slovakia: Štátny ústav pre kontrolu lieciv; Spain: Agencia Española de Medicamentos y Productos Sanitarios; Sweden: Medical Products Agency; Switzerland: Agency for Therapeutic Products; Ukraine: Ministry of Health

Keywords provided by Amgen:

Non-myeloid malignancy
Darbepoetin alfa
Clinical Trial

Study placed in the following topic categories:

Hematinics
Hematologic Diseases
Darbepoetin alfa
Anemia

Additional relevant MeSH terms:

Neoplasms
Hematinics
Hematologic Diseases
Therapeutic Uses

Hematologic Agents
Darbepoetin alfa
Anemia
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 09, 2009