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

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

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

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

Resource links provided by NLM:

MedlinePlus related topics: Anemia Cancer

Drug Information available for: Darbepoetin alfa

U.S. FDA Resources

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

Additional 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

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

No publications provided by Amgen

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):

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
Study First Received:	June 21, 2005
Last Updated:	May 7, 2009
ClinicalTrials.gov Identifier:	NCT00115167 History of Changes
Health Authority:	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; 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

Keywords provided by Amgen:

Oncology
Cancer-related anemia

Additional relevant MeSH terms:

Hematinics
Hematologic Diseases
Therapeutic Uses
Hematologic Agents

Darbepoetin alfa
Anemia
Pharmacologic Actions

ClinicalTrials.gov processed this record on November 25, 2009