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Fractionated Dosing Study: Study to Evaluate Darbepoetin Alfa for the Treatment of Anemia in Subjects With Non-Myeloid Malignancies

This study has been completed.
Information provided by:
Amgen Identifier:
First received: October 13, 2005
Last updated: March 4, 2010
Last verified: March 2010
The purpose of this study is to characterize the pharmacokinetics/pharmacodynamics (PK/PD) of darbepoetin alfa administered at a subcutaneous (SC) dose of 0.45 mcg/kg three times weekly (TIW) in anemic patients with non-myeloid malignancies receiving multicycle chemotherapy.

Condition Intervention Phase
Non-Myeloid Malignancies Anemia Cancer Drug: Darbepoetin alfa Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-label, Single-arm Study to Evaluate the Pharmacokinetics, Pharmacodynamics, and Safety of Darbepoetin Alfa Administered Three Times Per Week for the Treatment of Anemia in Subjects With Non-myeloid Malignancies Receiving Multicycle Chemotherapy

Resource links provided by NLM:

Further study details as provided by Amgen:

Primary Outcome Measures:
  • To characterize the PK of darbepoetin alfa administered at a SC dose of 0.45 mcg/kg TIW in the treatment of anemia in subjects with non-myeloid malignancies receiving multicycle chemotherapy [ Time Frame: 18 weeks ]

Secondary Outcome Measures:
  • To assess the effect of darbepoetin alfa treatment on hematopoietic response, red blood cell (RBC) transfusion requirements, and the safety of darbepoetin alfa in subjects receiving multicycle chemotherapy [ Time Frame: 18 weeks ]

Enrollment: 44
Study Start Date: August 2005
Study Completion Date: March 2007
Primary Completion Date: January 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: test treatment period Drug: Darbepoetin alfa
darbepoetin alfa SC dosing 0.45 mcg/kg 3 times per week through study day 40. Optional extended treatment period: 200 mcg Q2W through study day 110


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Non-myeloid malignancy
  • Currently receiving 3-week cyclic chemotherapy treatment with a minimum of 2 additional cycles of chemotherapy planned at the time of enrollment
  • Anemia predominately due to cancer or chemotherapy (Hb >= 9.0 and < 11.0 g/dL) at the time of screening
  • 18 years of age or older at the time of screening
  • Eastern Cooperative Oncology Group (ECOG) score 0-2
  • Adequate liver and kidney function Exclusion Criteria:
  • Known primary hematologic disorder, which could cause anemia, other than non-myeloid malignancies
  • History of chronic myeloid leukemia (CML), acute myeloid leukemia (AML), myelodysplastic syndrome (MDS), acute lymphocytic leukemia (ALL), hairy cell leukemia, Burkitt's lymphoma, or lymphoblastic lymphoma
  • Serum folate <= 2.0 ng/mL or vitamin B12 <= 200 pg/mL at screening (anemia related to nutritional deficiencies)
  • Iron deficiency [transferrin saturation (TSAT) < 15% and serum ferritin < 10 ng/mL] at screening
  • Other diagnoses not related to cancer or chemotherapy, which cause anemia (ie, hemolysis, bleeding, sickle cell anemia)
  • Clinically significant inflammatory disease as determined by the investigator (eg, rheumatoid arthritis, Crohn's disease)
  • Clinically significant co-morbid medical or psychiatric conditions that may impact subject safety or confound the ability to evaluate study endpoint as determined by the investigator
  • Unstable or uncontrolled cardiac disease or condition (ie, angina, congestive heart failure, or cardiac arrhythmia)
  • Diastolic blood pressure > 100 mmHg at screening
  • Known hypersensitivity of erythropoietic-stimulating proteins (ESPs) or any excipients
  • Known history of pure red cell aplasia
  • Known positive antibody response to an ESP
  • Use of investigational agents not approved or any indication during the previous 30 days prior to enrollment
  • ESP therapy (i.e., recombinant human erythropoietin [rHuEPO] or darbepoetin alfa) within 21 days prior to screening or between screening and the first dose of study drug
  • RBC transfusion(s) within 21 days prior to screening
  • Pregnant or breast-feeding women - Previously enrolled in this study
  • Known to be HIV, hepatitis B or C positive
  • Any disorder that would compromise the ability of the subject to give written informed consent and comply with study requirements and procedures
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Please refer to this study by its identifier: NCT00239239

Sponsors and Collaborators
Study Director: MD Amgen
  More Information

Additional Information:
Responsible Party: Global Development Leader, Amgen Inc. Identifier: NCT00239239     History of Changes
Other Study ID Numbers: 20040232
Study First Received: October 13, 2005
Last Updated: March 4, 2010

Keywords provided by Amgen:
Non-myeloid malignancy
Chemotherapy-induced anemia
Clinical Trials
Darbepoetin alfa

Additional relevant MeSH terms:
Hematologic Diseases
Darbepoetin alfa
Hematinics processed this record on August 18, 2017