Cancer
Conditions
Keywords
oncology, darbepoetin alfa, Aranesp®, Amgen, Non-myeloid malignancy
Brief summary
The study is designed to assess if the addition of intravenous (IV) iron to 500 mcg every 3 week (Q3W) darbepoetin alfa treatment enhances response as compared to the standard practice (oral iron or no iron administration).
Interventions
DRUGdarbepoetin alfa
Sponsors
Amgen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
- Subjects with non-myeloid malignancy (chronic myeloid leukemia \[CML\], acute leukemia \[acute myelogenous leukemia (AML) and acute lymphocytic leukemia (ALL)\], hairy cell leukemia, Burkitt's lymphoma and lymphoblastic lymphoma are specifically excluded) - Planned to receive at least 8 weeks of cyclic cytotoxic chemotherapy regardless of schedule (chemotherapy may already be ongoing at time of screening) - Hemoglobin concentration less than 11 g/dL within 24 hours before randomization - Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
Exclusion criteria
- Known (documented in medical records) history of seizure disorder (subjects with a previous history of seizure disorders will be eligible for the study, if they have had no evidence of seizure activity, and have not been taking anti-seizure medication for the previous 5 years) - Known (documented in medical records) history of thromboembolism - Known primary hematologic disorder which could cause anemia other than a non-myeloid malignancy (e.g., sickle cell anemia, thalassemia) - Radiotherapy within 4 weeks before randomization in which the radiation is administered to greater than 25% of the marrow - Unstable or uncontrolled disease/condition, related to or affecting cardiac function (e.g., unstable angina, congestive heart failure, uncontrolled hypertension and/or unstable cardiac arrhythmia) - Chronic inflammatory disease that is not stable (e.g., rheumatoid arthritis, Crohn's disease, peptic ulcer, ulcerative disease, etc) - Inadequate renal and/or liver function - Received any red blood cell transfusion within 14 days before randomization or any planned red blood cell 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 - Known sensitivity to iron administration - Subject of reproductive potential is evidently pregnant (e.g., positive serum HCG test) or is breast feeding - Subject of reproductive potential who is not using adequate contraceptive precautions - Subject has any kind of disorder that compromises the ability of the subject to give written informed consent and/or to comply with study procedures
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of subjects achieving a hematopoietic response (hemoglobin [hgb] greater than or equal to 12 g/dL or rise in hgb of greater than 2 g/dL) during the treatment period | — |
Secondary
| Measure | Time frame |
|---|---|
| The proportion of subjects with at least one red blood cell (RBC) transfusion from week 5 (day 29) to end of treatment period (EOTP) | — |
| Change in hemoglobin from baseline to EOTP | — |
| The proportion of subjects 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 5 to EOTP | — |
| The average hgb after achieving a hgb level greater than or equal to 11.0 g/dL | — |
| Time to hematopoietic response in days | — |
| Change in FACT-G Physical Well-being subscale from baseline to EOTP | — |
| Change in FACT-G total score from baseline to EOTP | — |
| Change in EuroQoL (EQ-5D) thermometer and ED-5D scores from baseline to EOTP | — |
| Patient reported outcomes: Change in Functional Assessment of Cancer Therapy (FACT)-Fatigue subscale score from baseline to EOTP | — |
Outcome results
None listed