A Study of Darbepoetin Alfa in Anemic Subjects Not Receiving Chemotherapy Who Have Completed the 20010103 Study - Full Text View

Purpose

The purpose of this study is to determine the safety of darbepoetin alfa beyond 16 weeks of treatment in subjects with anemia of cancer who are not receiving chemotherapy.

Condition	Intervention	Phase
Anemia Cancer	Drug: Placebo Drug: Darbepoetin alfa	Phase III

MedlinePlus related topics:

Anemia Cancer

ChemIDplus related topics:

Darbepoetin alfa

U.S. FDA Resources

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

Official Title:	A Multicenter, Randomised, Double-Blind, Placebo-Controlled Roll Over Study to Protocol 20010103 of Darbepoetin Alfa for the Treatment of Anemia of Cancer

Further study details as provided by Amgen:

Primary Outcome Measures:

Incidence of adverse events [ Time Frame: throughout study ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Confirmed antibody formation to investigational product [ Time Frame: throughout study ] [ Designated as safety issue: Yes ]
Deaths on study [ Time Frame: on study ] [ Designated as safety issue: Yes ]
Laboratory parameters [ Time Frame: throughout study ] [ Designated as safety issue: Yes ]
Vital signs (blood pressure) [ Time Frame: throughout study ] [ Designated as safety issue: Yes ]
Change in PRO scores [ Time Frame: from baseline to end of treatment ] [ Designated as safety issue: No ]

Enrollment:	371
Study Start Date:	August 2004
Study Completion Date:	March 2007
Primary Completion Date:	January 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Darbepoetin alfa: Experimental	Drug: Darbepoetin alfa Q4W
Placebo: Placebo Comparator	Drug: Placebo Q4W

Eligibility

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

Criteria

Inclusion Criteria:

- Subjects completing the planned 16 weeks of treatment on the 20010103 Anemia of Cancer protocol

Exclusion Criteria:

Subjects currently receiving or planned to receive cytotoxic chemotherapy or myelosuppressive radiotherapy
Subjects who have other diagnoses not related to the cancer which can cause anemia
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 enrollment
Subject of reproductive potential who is not using adequate contraceptive precautions
Concerns for subject's compliance with the protocol procedures

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00115167

Sponsors and Collaborators

Amgen

Investigators


Study Director:	MD	Amgen

More Information

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

Publications indexed to this study:

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:	20020149
First Received:	June 21, 2005
Last Updated:	February 20, 2008
ClinicalTrials.gov Identifier:	NCT00115167
Health Authority:	Australia: Therapeutic Goods Administration; Austria: Bundesamt für Sicherheit im Gesundheitswesen; Belgium: Service Public Federal Sante Publiquest, Securite de la Chaine 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; 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); 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

Keywords provided by Amgen:

Oncology

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 September 04, 2008

Sponsored by:	Amgen
Information provided by:	Amgen
ClinicalTrials.gov Identifier:	NCT00115167