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

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:

MedlinePlus related topics: Anemia Blood Transfusion and Donation Cancer

Drug Information available for: Darbepoetin Alfa

U.S. FDA Resources

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:

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

Publications:

Canon JL, Vansteenkiste J, Hedenus M, Gascon P, Bokemeyer C, Ludwig H, Vermorken J, Legg J, Pujol B, Bridges K. Transfusion risk in cancer patients with chemotherapy-induced anemia when initiating darbepoetin alfa therapy at a baseline hemoglobin level of <9 g/dL versus 9 to <10 g/dL versus ≥ 10 g/dL: an exploratory analysis of a phase 3 trial. Med Oncol. 2012 Sep;29(3):2291-9. doi: 10.1007/s12032-011-0103-x. Epub 2011 Nov 13.

Canon JL, Vansteenkiste J, Bodoky G, Mateos MV, Bastit L, Ferreira I, Rossi G, Amado RG. Randomized, double-blind, active-controlled trial of every-3-week darbepoetin alfa for the treatment of chemotherapy-induced anemia. J Natl Cancer Inst. 2006 Feb 15;98(4):273-84.

Vansteenkiste J, Hedenus M, Gascon P, Bokemeyer C, Ludwig H, Vermorken J, Hamilton L, Bridges K, Pujol B. Darbepoetin alfa for treating chemotherapy-induced anemia in patients with a baseline hemoglobin level < 10 g/dL versus > or = 10 g/dL: an exploratory analysis from a randomized, double-blind, active-controlled trial. BMC Cancer. 2009 Sep 3;9:311.

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 May 22, 2013