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

This study has been completed.
Sponsor:
Information provided by:
Amgen
ClinicalTrials.gov Identifier:
NCT00115167
First received: June 21, 2005
Last updated: May 7, 2009
Last verified: May 2009
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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:


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
Experimental: Darbepoetin alfa Drug: Darbepoetin alfa
Q4W
Placebo Comparator: Placebo 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:
No publications provided by Amgen

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Global Development Leader, Amgen Inc.
ClinicalTrials.gov Identifier: NCT00115167     History of Changes
Other Study ID Numbers: 20020149
Study First Received: June 21, 2005
Last Updated: May 7, 2009
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:
Anemia
Hematologic Diseases
Darbepoetin alfa
Hematinics
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 15, 2014