A Phase 2 Study of ZK219477 (ZK-EPO) in Patients With Breast Cancer and Brain Metastases
- Participants will be given ZK219477 intravenously over approximately 30 minutes every
three weeks.
- During all treatment cycles a physical exam and questions about the participants
general health and specific questions about any problems they may be having will be
performed.
- At least every three weeks blood tests will be done to assess the effect of ZK219477 on
the body.
- After every 2 cycles of treatment, participants will have additional scans to assess
the effect of ZK219477 on their cancer. This will include a CT scan of the abdomen,
chest, and pelvis, and an MRI of the brain.
- At the time of the standard MRI, participants will be asked to undergo an additional
MRI sequence, which means they will be in the MRI machine for approximately 15-20 more
minutes.
Interventional
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Objective Response Rate in the Central Nervous System (CNS)
Objective response rate is defined as at least a 50 percent reduction in the Central Nervous system target lesion volume compared to the lesion volume at baseline.
2 years
No
Nancy Lin, MD
Principal Investigator
Dana-Farber Cancer Institute
United States: Food and Drug Administration
06-268
NCT00496379
July 2007
January 2012
Name | Location |
---|---|
Dana-Farber Cancer Institute | Boston, Massachusetts 02115 |