Study of Darbepoetin Alfa for the Treatment of Anemia of Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Amgen
ClinicalTrials.gov Identifier:
NCT00091858
First received: September 17, 2004
Last updated: May 6, 2013
Last verified: May 2013
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Multicenter, Randomized, Double-blind, Placebo-controlled Study 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:
  • 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
Experimental: Darbepoetin alfa 6.75 mcg/kg Q4W Drug: Darbepoetin Alfa
6.75 mcg/kg Q4W
Placebo Comparator: Placebo Q4W 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Sponsors and Collaborators
Amgen
Investigators
Study Director: MD Amgen
  More Information

Additional Information:
Publications:
Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT00091858     History of Changes
Obsolete Identifiers: NCT00098696
Other Study ID Numbers: 20010103
Study First Received: September 17, 2004
Last Updated: May 6, 2013
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

Additional relevant MeSH terms:
Anemia
Hematologic Diseases
Darbepoetin alfa
Hematinics
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 21, 2014