Anemia, Cancer, Non-Myeloid Malignancies
Conditions
Keywords
Non-myeloid malignancy, Chemotherapy-induced anemia, Oncology, Clinical Trials, Pharmacokinetics, Darbepoetin alfa, Aranesp, 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.
Interventions
DRUGDarbepoetin alfa
darbepoetin alfa SC dosing 0.45 mcg/kg 3 times per week through study day 40. Optional extended treatment period: 200 mcg Q2W through study day 110
Sponsors
Amgen
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 |
Outcome results
None listed