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
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: 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 July 23, 2014