Clinical trial NCT00239239: Fractionated Dosing Study: Study to Evaluate Darbepoetin Alfa for the Treatment of Anemia in Subjects With Non-Myeloid Malignancies
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Non-Myeloid Malignancies
Anemia
Cancer
Keywords: Non-myeloid malignancy
Chemotherapy-induced anemia
Oncology
Clinical Trials
Pharmacokinetics
Darbepoetin alfa
Aranesp
Amgen
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2005-10-17
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: 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
timeFrame: 18 weeks
Secondary outcomes:
measure: 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
timeFrame: 18 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References: