Anemia, Non-Myeloid Malignancies
Conditions
Keywords
Non-myeloid malignancy, Darbepoetin alfa, Clinical Trial
Brief summary
The purpose of this study is to evaluate the efficacy of darbepoetin alfa as 500ug once every 3 weeks to show that the dose and schedule are not inferior to darbepoetin alfa administered as 2.25ug/kg once per week in the treatment of anemia in subjects with non-myeloid malignancies.
Interventions
DRUGDarbepoetin alfa - 2.25 mcg/kg
Darbepoetin alfa 2.25 mcg/kg QW dosing/ placebo Q3W
DRUGDarbepoetin alfa - 500mcg
Darbepoetin alfa 500mcg Q3W dosing / placebo QW
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
* Non-myeloid malignancy * At least 12 additional weeks of cyclic cytotoxic chemotherapy anticipated regardless of schedule * Eastern Cooperative Oncology Group performance status of 0-2 * Hemoglobin concentration of less than 11 g/dL within 24 hours before randomization * Of legal age at the time written informed consent is obtained
Exclusion criteria
* Known history of seizure disorder * Known primary hematologic disorder, which could cause anemia, other than a non-myeloid malignancy * Unstable or uncontrolled disease/condition, related to or affecting cardiac function * Clinically significant inflammatory disease * Inadequate renal and/or liver function * Known positive HIV test * Previously suspected of or confirmed to have neutralizing antibodies to rHuEPO * Received more than 2 red blood cell (RBC) transfusions within 4 weeks before 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 before randomization or any planned erythropoietic therapy between randomization and study day 1 * Other investigational procedures * Subject is currently enrolled in or less than 30 days since receipt of any investigational drug or device that is not approved by the applicable regulatory authority * Pregnant or breast feeding * Not using adequate contraceptive precautions * Known sensitivity to any of the products to be administered during dosing * Previously randomized in this study * Concerns for subject's compliance with protocol procedures
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of at least one RBC transfusion from week 5 to End of Treatment Period (EOTP) | from week 5 to EOTP |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of at least one RBC transfusion from week 1 (day 1) to EOTP | from week 1 (day 1) to EOTP |
| Incidence of achieving a hemoglobin concentration greater than or equal to 11.0 g/dL, in the absence of RBC transfusions in the preceding 28 days, from week 1 to EOTP | from week 1 to EOTP |
| Change in FACT-G Physical Well-being subscale from baseline to EOTP | from baseline to EOTP |
| Change in hemoglobin from baseline to EOTP | from baseline to EOTP |
| Change in FACT-Fatigue subscale score from baseline to EOTP | from baseline to EOTP |
| Change in FACT-G total score from baseline to EOTP | from baseline to EOTP |
| Change in EQ-5D Thermometer from baseline to EOTP | from baseline to EOTP |
| Incidence of achieving a hemoglobin concentration of greater than or equal to 11.0 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 BSI Depression scale score 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 number of caregiver hours from baseline to EOTP | from baseline to EOTP |
| 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 |
| Incidence of an increase in hemoglobin concentration of greater than or equal to 1 g/dL in a 14-day window and any negative clinical consequences | throughout study |
| Incidence of a confirmed antibody formation to darbepoetin alfa | throughout study |
| Change in BSI Anxiety scale score from baseline to EOTP | from baseline to EOTP |
Outcome results
None listed