Study of Darbepoetin Alfa for the Treatment of Anemia of Cancer - Full Text View

Sponsored by:	Amgen
Information provided by:	Amgen
ClinicalTrials.gov Identifier:	NCT00091858

Purpose

The purpose of this study is to evaluate the efficacy of darbepoetin alfa versus placebo in reducing the occurrences of red blood cell transfusions in subjects with anemia of cancer who are not receiving chemotherapy.

Condition	Intervention	Phase
Anemia Cancer	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, Efficacy Study
Official Title:	A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Darbepoetin Alfa for the Treatment of Anemia of Cancer

Further study details as provided by Amgen:

Primary Outcome Measures:

Occurrences of red blood cell transfusion [ Time Frame: from study day 29 (week 5) to week 17 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Incidence of first red blood cell transfusion [ Time Frame: from week 5 (study day 29) to week 17 (study day 119) ] [ Designated as safety issue: No ]
Change in hemoglobin concentration measured [ Time Frame: from baseline (study day 1) to EOTP ] [ Designated as safety issue: No ]
Adverse events and serious adverse events [ Time Frame: throughout study for subjects who received at least 1 dose of investigational product ] [ Designated as safety issue: Yes ]
Survival [ Time Frame: deaths on study and deaths in long-term follow-up period for subjects who received at least 1 dose of investigational product ] [ Designated as safety issue: Yes ]
Incidence, if any, of neutralizing antibody formation to investigational product [ Time Frame: throughout study for subjects who received at least 1 dose of investigational product ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	1000
Study Start Date:	April 2004
Study Completion Date:	December 2006
Primary Completion Date:	October 2006 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Darbepoetin alfa 6.75 mcg/kg Q4W: Experimental	Drug: Darbepoetin Alfa 6.75 mcg/kg Q4W
Placebo Q4W: Placebo Comparator	Drug: Placebo Placebo Q4W

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 malignancies
anemia due to cancer
ECOG status 0 to 2
greater than or equal to 4-month expectancy
greater than or equal to 18 years and of legal age for informed consent
screening hemoglobin concentration less than or equal to 11.0g/dL
adequate serum folate and vitamin B12
adequate renal and liver function
written informed consent

Exclusion Criteria:

subjects currently receiving or planned to receive cytotoxic chemotherapy or myelosuppressive radiotherapy during the study or within 4 weeks before randomization
in complete remission, as determined by the investigator
subjects who have other diagnoses not related to the cancer which cause anemia (eg. gastrointestinal bleeding, renal disease, etc)
documented history of pure red cell aplasia
Known history of seizure disorder
cardiac condition: uncontrolled angina, congestive heart failure, known ejection fraction less than 40%, or uncontrolled cardiac arrhythmia
uncontrolled hypertension
clinically significant systemic infection or chronic inflammatory disease present at the time of randomization
iron deficiency
known positive test for HIV infection
previously suspected of or confirmed to have neutralizing antibodies to rHuEPO or darbepoetin alfa
received rHuEPO or darbepoetin alfa therapy within 4 weeks of randomization
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
subject of reproductive potential who is not using adequate contraceptive precautions
known hypersensitivity to mammalian-derived product or any other ingredients in the investigational product
previously randomized into this study
concerns for subject's compliance with the protocol procedures

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00091858

Sponsors and Collaborators

Amgen

Investigators

Study Director:

MD

Amgen

More Information

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

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

FDA-approved Drug Labeling This link exits the ClinicalTrials.gov site

Publications of Results:

Smith RE Jr, Aapro MS, Ludwig H, Pintér T, Smakal M, Ciuleanu TE, Chen L, Lillie T, Glaspy JA. Darbepoetin alpha for the treatment of anemia in patients with active cancer not receiving chemotherapy or radiotherapy: results of a phase III, multicenter, randomized, double-blind, placebo-controlled study. J Clin Oncol. 2008 Mar 1;26(7):1040-50. Epub 2008 Jan 28.

Responsible Party:	Amgen Inc. ( Global Development Leader )
Study ID Numbers:	20010103
Study First Received:	September 17, 2004
Last Updated:	May 15, 2008
ClinicalTrials.gov Identifier:	NCT00091858
Health Authority:	Australia: Therapeutic Goods Administration; Austria: Bundesamt für Sicherheit im Gesundheitswesen; Belgium: Service Public Fédéral Santé Publique, Sécurité de la Chaîne alimentaire et Environnement; Canada: Health Canada; Czech Republic: Statni ustav pro kontrolu leciv; Estonia: State Agency of Medicines; Hungary: National Institute of Pharmacy; Italy: Ministry of Health; Latvia: State Agency of Medicines; Romania: Ministry of Health and the Family; Russia: Ministry of Health; Slovakia: Štátny ústav pre kontrolu lieciv; Spain: Agencia Española de Medicamentos y Productos Sanitarios; Switzerland: Agency for Therapeutic Products; Ukraine: Ministry of Health; United Kingdom: Medicines and Healthcare Products Regulatory Agency; United States: Food and Drug Administration; Lithuania: State Medicines Control Agency of Lithuania; Netherlands: Medicines Evaluation Board; Netherlands: Medisch Centrum Rijnmond_Zuid, lcatie Zuider; Poland: Drug Institut; Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products; Portugal: Instituto Nacional da Farmácia e do Medicamento (INFARMED)

Keywords provided by Amgen:

Cancer-related anemia

Study placed in the following topic categories:

Hematologic Diseases
Darbepoetin alfa
Anemia

Additional relevant MeSH terms:

Hematinics
Therapeutic Uses
Hematologic Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009