Anemia, Cancer
Conditions
Keywords
Oncology, Cancer-related anemia
Brief summary
The purpose of this study is to determine the safety of darbepoetin alfa beyond 16 weeks of treatment in subjects with anemia of cancer who are not receiving chemotherapy.
Interventions
DRUGPlacebo
Q4W
DRUGDarbepoetin alfa
Q4W
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 completing the planned 16 weeks of treatment on the 20010103 Anemia of Cancer protocol
Exclusion criteria
* Subjects currently receiving or planned to receive cytotoxic chemotherapy or myelosuppressive radiotherapy * Subjects who have other diagnoses not related to the cancer which can cause anemia * Known history of seizure disorder * Cardiac condition: uncontrolled angina, congestive heart failure, known ejection fraction less than 40%, or uncontrolled cardiac arrhythmia * Uncontrolled hypertension * Clinically significant systemic infection or chronic inflammatory disease present at the time of enrollment * Subject of reproductive potential who is not using adequate contraceptive precautions * Concerns for subject's compliance with the protocol procedures
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of adverse events | throughout study |
Secondary
| Measure | Time frame |
|---|---|
| Confirmed antibody formation to investigational product | throughout study |
| Deaths on study | on study |
| Laboratory parameters | throughout study |
| Vital signs (blood pressure) | throughout study |
| Change in PRO scores | from baseline to end of treatment |
Outcome results
None listed