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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.
Sponsored by: Amgen
Information provided by: Amgen
ClinicalTrials.gov Identifier: NCT00239239
  Purpose

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 II

MedlinePlus related topics: Anemia Cancer
Drug Information available for: Darbepoetin alfa
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Single Group Assignment, Pharmacokinetics/Dynamics Study
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

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

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

Estimated Enrollment: 44
Study Start Date: August 2005
Estimated Study Completion Date: June 2006
  Eligibility

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

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

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00239239

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: 20040232
Study First Received: October 13, 2005
Last Updated: December 20, 2007
ClinicalTrials.gov Identifier: NCT00239239  
Health Authority: United States: Food and Drug Administration

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

Study placed in the following topic categories:
Hematologic Diseases
Darbepoetin alfa
Anemia

Additional relevant MeSH terms:
Neoplasms
Hematinics
Therapeutic Uses
Hematologic Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009