• Purpose

  2 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.
  

  
  

  status:	completed
  conditions:	Anemia ; Non-Myeloid Malignancies
  interventions:	darbepoetin alfa ; IV iron dextran
  phase:	Phase 2
  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 ]

  secondary outcome measures:

  • Time to achieving target hemoglobin (Hgb 11 g/dL) [ Time Frame: 3 months ]
  • Incidence and severity of adverse events including historical events of interest [ Time Frame: 3 months ]

  enrollment: 243

  study start date: December 2006

  study completion date: March 2008

  
  

  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

  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
  • 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:

  MD, Study Director, Amgen

• More information

  Notice regarding posted summaries of trial results
  
  To access clinical trial results information click on this link
  
  FDA-approved Drug Labeling
  
  AmgenTrials clinical trials website
  
  

  first received:	November 16, 2006
  last updated:	May 7, 2009
  ClinicalTrials.gov Identifier:	NCT00401544
  health authority:	Romania: Ministry of Health and the Family Russia: Ministry of Health United States: Food and Drug Administration United States: Institutional Review Board

Information obtained from ClinicalTrials.gov on September 25, 2009   Link to the current ClinicalTrials.gov record.

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