A Study of Darbepoetin Alfa for the Treatment of Anemia in Subjects With Non-Myeloid Malignancy Receiving Multicycle Chemotherapy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Amgen
ClinicalTrials.gov Identifier:
NCT00118638
First received: June 30, 2005
Last updated: April 25, 2013
Last verified: April 2013
  Purpose

The purpose of this study is to evaluate the efficacy of darbepoetin alfa as 500ug once every 3 weeks to show that the dose and schedule are not inferior to darbepoetin alfa administered as 2.25ug/kg once per week in the treatment of anemia in subjects with non-myeloid malignancies.


Condition Intervention Phase
Anemia
Non-Myeloid Malignancies
Drug: Darbepoetin alfa - 2.25 mcg/kg
Drug: Darbepoetin alfa - 500mcg
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double Blind, Active-Controlled Study of Darbepoetin Alfa for the Treatment of Anemia in Subjects With Non-Myeloid Malignancy Receiving Multicycle Chemotherapy

Resource links provided by NLM:


Further study details as provided by Amgen:

Primary Outcome Measures:
  • Incidence of at least one RBC transfusion from week 5 to End of Treatment Period (EOTP) [ Time Frame: from week 5 to EOTP ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Incidence of achieving a hemoglobin concentration of greater than or equal to 11.0 g/dL, in the absence of RBC transfusions in the preceding 28 days, from week 5 to EOTP [ Time Frame: from week 5 to EOTP ] [ Designated as safety issue: No ]
  • Incidence of at least one RBC transfusion from week 1 (day 1) to EOTP [ Time Frame: from week 1 (day 1) to EOTP ] [ Designated as safety issue: No ]
  • Incidence of achieving a hemoglobin concentration greater than or equal to 11.0 g/dL, in the absence of RBC transfusions in the preceding 28 days, from week 1 to EOTP [ Time Frame: from week 1 to EOTP ] [ Designated as safety issue: No ]
  • Change in FACT-G Physical Well-being subscale from baseline to EOTP [ Time Frame: from baseline to EOTP ] [ Designated as safety issue: No ]
  • Change in hemoglobin from baseline to EOTP [ Time Frame: from baseline to EOTP ] [ Designated as safety issue: No ]
  • Change in FACT-Fatigue subscale score from baseline to EOTP [ Time Frame: from baseline to EOTP ] [ Designated as safety issue: No ]
  • Change in FACT-G total score from baseline to EOTP [ Time Frame: from baseline to EOTP ] [ Designated as safety issue: No ]
  • Change in EQ-5D Thermometer from baseline to EOTP [ Time Frame: from baseline to EOTP ] [ Designated as safety issue: No ]
  • Change in BSI Anxiety scale score from baseline to EOTP [ Time Frame: from baseline to EOTP ] [ Designated as safety issue: No ]
  • Change in BSI Depression scale score from baseline to EOTP [ Time Frame: from baseline to EOTP ] [ Designated as safety issue: No ]
  • Incidence and severity of adverse events [ Time Frame: throughout study ] [ Designated as safety issue: Yes ]
  • Incidence of hemoglobin concentration greater than 13.0 g/dL at any time on study [ Time Frame: at any time on study ] [ Designated as safety issue: Yes ]
  • Change in number of caregiver hours from baseline to EOTP [ Time Frame: from baseline to EOTP ] [ Designated as safety issue: No ]
  • Incidence of an increase in hemoglobin concentration greater than or equal to 2 g/dL in a 28-day window and any negative clinical consequences [ Time Frame: throughout study ] [ Designated as safety issue: Yes ]
  • Incidence of an increase in hemoglobin concentration of greater than or equal to 1 g/dL in a 14-day window and any negative clinical consequences [ Time Frame: throughout study ] [ Designated as safety issue: Yes ]
  • Incidence of a confirmed antibody formation to darbepoetin alfa [ Time Frame: throughout study ] [ Designated as safety issue: Yes ]

Enrollment: 705
Study Start Date: March 2004
Study Completion Date: January 2005
Primary Completion Date: December 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Darbepoetin alfa 500 mcg - Group A Drug: Darbepoetin alfa - 500mcg
Darbepoetin alfa 500mcg Q3W dosing / placebo QW
Active Comparator: Darbepoetin alfa 2.25 mcg/kg - Group B Drug: Darbepoetin alfa - 2.25 mcg/kg
Darbepoetin alfa 2.25 mcg/kg QW dosing/ placebo Q3W

  Eligibility

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

Inclusion Criteria:

  • Non-myeloid malignancy
  • At least 12 additional weeks of cyclic cytotoxic chemotherapy anticipated regardless of schedule
  • Eastern Cooperative Oncology Group performance status of 0-2
  • Hemoglobin concentration of less than 11 g/dL within 24 hours before randomization
  • Of legal age at the time written informed consent is obtained

Exclusion Criteria:

  • Known history of seizure disorder
  • Known primary hematologic disorder, which could cause anemia, other than a non-myeloid malignancy
  • Unstable or uncontrolled disease/condition, related to or affecting cardiac function
  • Clinically significant inflammatory disease
  • Inadequate renal and/or liver function
  • Known positive HIV test
  • Previously suspected of or confirmed to have neutralizing antibodies to rHuEPO
  • Received more than 2 red blood cell (RBC) transfusions within 4 weeks before randomization or any RBC transfusion within 14 days before randomization, or any planned RBC transfusion between randomization and study day 1
  • Received any erythropoietic therapy within 4 weeks before randomization or any planned erythropoietic therapy between randomization and study day 1
  • Other investigational procedures
  • Subject is currently enrolled in or 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
  • Not using adequate contraceptive precautions
  • Known sensitivity to any of the products to be administered during dosing
  • Previously randomized in this study
  • Concerns for subject's compliance with protocol procedures
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00118638

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

Additional Information:
Publications:
Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT00118638     History of Changes
Other Study ID Numbers: 20030231
Study First Received: June 30, 2005
Last Updated: April 25, 2013
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Paul_Ehrlich-Institut Bundesamt fur Sera und Impfstoffe
Hungary: National Institute of Pharmacy
Italy: Local Ethics Committees
Latvia: State Agency of Medicines
Lithuania: State Medicines Control Agency of Lithuania
Netherlands: Medisch Centrum Rijnmond_Zuid, lcatie Zuider
Norway: Norwegian Medicines Agency
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
Slovakia: Štátny ústav pre kontrolu lieciv
Spain: Agencia Española de Medicamentos y Productos Sanitarios
Sweden: Medical Products Agency
Switzerland: Agency for Therapeutic Products
Ukraine: Ministry of Health
Austria: Bundesamt für Sicherheit im Gesundheitswesen
Belgium: Service Public Federal Sante Publiquest, Securite de la Chaine alimentaire et Environnement
Bulgaria: Ministry of Health
Czech Republic: Statni ustav pro kontrolu leciv
Denmark: Laegemiddelstyrelsen
Estonia: State Agency of Medicines
Finland: Lääkelaitos
United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Amgen:
Non-myeloid malignancy
Darbepoetin alfa
Clinical Trial

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

ClinicalTrials.gov processed this record on April 22, 2014