A Multicenter, Randomized, Open Label Dose Finding Study of Mircera in Anemic Patients With Stage IIIB or IV Non-small Cell Lung Cancer Receiving First Line Myelosuppressive Chemotherapy
Phase 2
18 Years
N/A
18 Years
N/A
Not Enrolling
Both
Anemia
Both
Anemia
Trial Information
A Multicenter, Randomized, Open Label Dose Finding Study of Mircera in Anemic Patients With Stage IIIB or IV Non-small Cell Lung Cancer Receiving First Line Myelosuppressive Chemotherapy
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.
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Average Hb change from baseline
Outcome Time Frame:
Weeks 5-13
Safety Issue:
No
Principal Investigator
Clinical Trials
Investigator Role:
Study Director
Investigator Affiliation:
Hoffmann-La Roche
Authority:
United States: Food and Drug Administration
Study ID:
NH19960
NCT ID:
NCT00327535
Start Date:
May 2006
Completion Date:
October 2008
Related Keywords:
- Anemia
- Anemia
- Carcinoma, Non-Small-Cell Lung
- Lung Neoplasms
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