Darbepoetin Alfa With or Without IV Iron - Full Text View

Sponsored by:	Amgen
Information provided by:	Amgen
ClinicalTrials.gov Identifier:	NCT00401544

Purpose

Two different doses of darbepoetin alfa will be administered subcutaneous (SC) on a Q3W schedule with or without the administration of intravenous (IV) iron supplementation in the treatment of anemia in subjects with non myeloid malignancies receiving multicycle chemotherapy and have hemoglobin levels ≤10.0 g/dL.

Condition	Intervention	Phase
Anemia Non-Myeloid Malignancies	Drug: darbepoetin alfa Drug: IV iron dextran	Phase II

MedlinePlus related topics: Anemia Cancer

Drug Information available for: Darbepoetin alfa Dextrans Iron-dextran complex

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study
Official Title:	Once Per Cycle Treatment of Anemia With Darbepoetin Alfa With Iron in Subjects With Non Myeloid Malignancies

Further study details as provided by Amgen:

Primary Outcome Measures:

The proportion of subjects who achieve the target hemoglobin (Hgb 11 g/dL) during the treatment period in the absence of a RBC transfusion within the prior 28 days [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Time to achieving target hemoglobin (Hgb 11 g/dL) [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Incidence and severity of adverse events including historical events of interest [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]

Enrollment:	243
Study Start Date:	December 2006
Study Completion Date:	March 2008
Primary Completion Date:	December 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
darbepoetin alfa 300mcg plus IV iron Q3W: Active Comparator	Drug: darbepoetin alfa Darbepoetin alfa will be administered at a fixed dose of either 300mcg or 500 mcg Q3W based on the subject's treatment arm assignment. Drug: IV iron dextran 400 mg at each dosing visit if assigned
darbepoetin alfa 300mcg Q3W: Active Comparator	Drug: darbepoetin alfa Darbepoetin alfa will be administered at a fixed dose of either 300mcg or 500 mcg Q3W based on the subject's treatment arm assignment.
darbepoetin alfa 500 mcg Q3W: Active Comparator	Drug: darbepoetin alfa Darbepoetin alfa will be administered at a fixed dose of either 300mcg or 500 mcg Q3W based on the subject's treatment arm assignment.
darbepoetin alfa 500 mcg plus IV iron Q3W: Active Comparator	Drug: darbepoetin alfa Darbepoetin alfa will be administered at a fixed dose of either 300mcg or 500 mcg Q3W based on the subject's treatment arm assignment. Drug: IV iron dextran 400 mg at each dosing visit if assigned

Eligibility

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

Criteria

Inclusion Criteria:

Subjects with active non myeloid malignancy(cies) including lymphocytic leukemias
Received chemotherapy and expected to receive at least 8 additional weeks of cyclic cytotoxic chemotherapy
Anemia due to chemotherapy (screening Hgb <or = 10.0 g/dL)
at least 18 years of age at screening

Exclusion Criteria:

Subjects with acute myelogenous leukemia (AML), chronic myelogenous leukemia (CML), or myelodysplastic syndromes (MDS)
Other underlying hematologic disorder, which could cause anemia, other than a non myeloid malignancy
Active bleeding
Severe, unstable, active chronic inflammatory disease (eg ulcerative disease, peptic ulcer disease, rheumatoid arthritis)
Active, unstable systemic or chronic infection
Planned elective surgery during the study where significant blood loss is expected
Unstable angina, or uncontrolled cardiac arrhythmia
Uncontrolled hypertension (diastolic blood pressure > 100 mmHg)
History of pure red cell aplasia (PRCA)
History of deep venous thrombosis
Known positive human immunodeficiency virus (HIV) test or acquired immune deficiency syndrome (AIDS) status
Any RBC transfusion within 28 days before randomization and/or during screening
Subjects currently receiving thalidomide or lenalidomide without prophylactic anticoagulant therapy
Subjects currently receiving or planned to receive myeloablative radiation therapy
Subjects who have received bone marrow or stem cell transplant in the 6 months prior to screening or planned during the study
Received any erythropoietic therapy within 28 days before randomization and/or during screening (eg rHuEPO or darbepoetin alfa)
Subject has known sensitivity to any erythropoietic agents, the investigational product or its excipients to be administered during this study
Subject has known sensitivity to iron administration
Subjects who are pregnant or breast feeding

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00401544

Sponsors and Collaborators

Amgen

Investigators

Study Director:

MD

Amgen

More Information

AmgenTrials clinical trials website This link exits the ClinicalTrials.gov site

Responsible Party:	Amgen Inc. ( Global Development Leader )
Study ID Numbers:	20060103
Study First Received:	November 16, 2006
Last Updated:	August 5, 2008
ClinicalTrials.gov Identifier:	NCT00401544
Health Authority:	Romania: Ministry of Public Health; Russia: Ministry of Health and Social Development of the Russian Federation; United States: Food and Drug Administration; United States: Institutional Review Board

Keywords provided by Amgen:

anemia
chemotherapy induced anemia
darbepoetin alfa
cancer

Study placed in the following topic categories:

Iron-Dextran Complex
Hematologic Diseases
Darbepoetin alfa

Anemia
Iron
Dextrans

Additional relevant MeSH terms:

Neoplasms
Hematinics
Therapeutic Uses
Growth Substances
Hematologic Agents

Physiological Effects of Drugs
Trace Elements
Micronutrients
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009