Status:
COMPLETED
Fractionated Dosing Study: Study to Evaluate Darbepoetin Alfa for the Treatment of Anemia in Subjects With Non-Myeloid Malignancies
Lead Sponsor:
Amgen
Conditions:
Non-Myeloid Malignancies
Anemia
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 anemi...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2007
Estimated Enrollment :
44 Patients enrolled
Trial Details
Trial ID
NCT00239239
Start Date
August 1 2005
End Date
March 1 2007
Last Update
March 5 2010
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