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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00239239
Recruitment Status : Completed
First Posted : October 17, 2005
Last Update Posted : March 5, 2010
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Brief Summary:
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 or disease Intervention/treatment Phase
Non-Myeloid Malignancies Anemia Cancer Drug: Darbepoetin alfa Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 44 participants
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
Study Start Date : August 2005
Actual Primary Completion Date : January 2007
Actual Study Completion Date : March 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anemia

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. 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 :
  1. 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 ]

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00239239

Sponsors and Collaborators
Study Director: MD Amgen

Additional Information:
Responsible Party: Global Development Leader, Amgen Inc. Identifier: NCT00239239     History of Changes
Other Study ID Numbers: 20040232
First Posted: October 17, 2005    Key Record Dates
Last Update Posted: March 5, 2010
Last Verified: March 2010

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

Additional relevant MeSH terms:
Hematologic Diseases
Darbepoetin alfa