Anemia, Non-Myeloid Malignancies
Conditions
Keywords
Non-myeloid malignancy, Chemotherapy-induced anemia
Brief summary
The purpose of this study is to compare the effect of darbepoetin alfa against placebo for the treatment of anemia in subjects with non-myeloid malignancies receiving multicycle chemotherapy.
Interventions
DRUGDarbepoetin alfa
Q3W 300 mcg darbepoetin alfa
DRUGPlacebo
Q3W dosing of placebo
Sponsors
Amgen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subjects with non-myeloid malignancy * At least 12 additional weeks of cyclic cytotoxic chemotherapy anticipated regardless of schedule * Hemoglobin concentration less than 11.0 g/dL within 24 hours before randomization * Adequate serum folate and vitamin B12 * Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 * Of legal age at the time written informed consent is obtained
Exclusion criteria
* Known history of seizure disorder * Known primary hematologic disorder causing anemia other than non-myeloid malignancies * Unstable/uncontrolled cardiac condition * Clinically significant inflammatory disease * Other diagnoses not related to the cancer which can cause anemia * Inadequate renal and liver function * Iron deficiency * Known positive test for HIV infection * Previously suspected of or confirmed to have neutralizing antibodies to rHuEPO * Received more than 2 red blood cell (RBC) transfusions within 4 weeks of randomization; or any RBC transfusion within 14 days before randomization; or any planned RBC transfusion between randomization and study day 1 * Received any erythropoietic therapy within 4 weeks of study day 1 or any planned erythropoietic therapy between randomization and study day 1 * Other investigational procedures * Currently enrolled in or has not yet completed at least 30 days since ending other investigational device or drug trial(s), or subject receiving other investigational agent(s) * Pregnant or breast feeding * Not using adequate contraceptive precautions * Previously randomized into this study * Known hypersensitivity to any products to be administered * Concerns for subject's compliance
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of red blood cell (RBC) transfusion from week 5 to End of Treatment Period (EOTP) | from week 5 to EOTP |
Secondary
| Measure | Time frame |
|---|---|
| Number of RBC transfusions from week 5 to EOTP | from week 5 to EOTP |
| Change in FACT-Fatigue subscale score from baseline to EOTP | from baseline to EOTP |
| Change in FACT-G Physical Well-being subscale from baseline to EOTP | from baseline to EOTP |
| Incidence and severity of adverse events | throughout study |
| Incidence of hemoglobin concentration greater than 13.0 g/dL at any time on study | at any time on study |
| Change in FACT-G total score from baseline to EOTP | from baseline to EOTP |
| Incidence of achieving a hemoglobin concentration of greater than or equal to 11 g/dL in the absence of RBC transfusions in the preceding 28 days from week 5 to EOTP | from week 5 to EOTP |
| Change in EQ-5D Thermometer from baseline to EOTP | from baseline to EOTP |
| Change in BSI Anxiety scale score from baseline to EOTP | from baseline to EOTP |
| Change in BSI Depression scale score from baseline to EOTP | from baseline to EOTP |
| Change in number of caregiver hours from baseline to EOTP | from baseline to EOTP |
| Incidence of a confirmed antibody formation to darbepoetin alfa | throughout study |
| Incidence of an increase in hemoglobin concentration greater than or equal to 2 g/dL in a 28-day window and any negative clinical consequences | throughout study |
Outcome results
None listed