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

• Status: Completed
• Trial end date: 2007-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Amgen
• Treatments: Darbepoetin alfa

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