Anemia
Conditions
Brief summary
This 4 arm study will assess the optimal starting dose of Mircera in the treatment of anemia in patients with non-small cell lung cancer receiving first line myelosuppressive chemotherapy. Patients will be randomized to receive either Mircera 6.3 micrograms/kg, 9 micrograms/kg or 12 micrograms/kg s.c. every 3 weeks or darbepoetin alfa according to the approved local label (either 6.75 micrograms/kg s.c. every 3 weeks, or 2.25 micrograms/kg every week). The anticipated time on study treatment is \<3 months and the target sample size is 100-500 individuals.
Interventions
DRUGDarbepoetin alfa
According to the approved local label (6.75 micrograms/kg every 3 weeks, or 2.25 micrograms/kg every week)
DRUGmethoxy polyethylene glycol-epoetin beta [Mircera]
6.3 micrograms/kg every 3 weeks
Sponsors
Hoffmann-La Roche
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
* \>=18 years of age; * stage III or IV non-small cell lung cancer receiving first line myelosuppressive chemotherapy; * myelosuppressive chemotherapy scheduled for at least 9 weeks; * anemia at screening visit.
Exclusion criteria
* transfusion of red blood cells during the 4 weeks prior to first planned dose of study medication; * iron deficiency anemia, or anemia caused by gastrointestinal bleeding; * prior treatment with Mircera.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Average Hb change from baseline | Weeks 5-13 |
Secondary
| Measure | Time frame |
|---|---|
| Target Hb therapeutic range, average Hb values, hematopoietic response. | Days 2-85 |
| Red blood cell (RBC) transfusions | Weeks 5-13 |
| Adverse events (AEs), laboratory parameters, premature withdrawals | Throughout study |
Countries
Australia, Austria, Belgium, Canada, Czechia, Estonia, Finland, France, Germany, Greece, Hong Kong, Hungary, Italy, Poland, Spain
Outcome results
None listed