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

Phase 2

Completed

• Conditions: Non-Myeloid Malignancies; Anemia; Cancer
• Interventions: Drug: Darbepoetin alfa

• Registration Number: NCT00239239
• Lead Sponsor: Amgen

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-08
• Study First Submitted: 2005-10-13
• Study First Submitted QC: 2005-10-13
• Study First Posted: 2005-10-17
• Primary Completion: 2007-01
• Study Completion: 2007-03
• Status Verified: 2010-03
• Last Update Submitted: 2010-03-04
• Last Update Posted: 2010-03-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 44

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
test treatment period	Darbepoetin alfa	-

Primary Outcome Measures

Name	Time	Method
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	18 weeks

Secondary Outcome Measures

Name	Time	Method
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	18 weeks