Phase II Trial Of ZK-EPO (ZK 219477) (Sagopilone) In Metastatic Melanoma
Status:
Completed
Trial end date:
2013-01-01
Target enrollment:
Participant gender:
Summary
The purpose of this study is to find out how effective an investigational drug named ZK-Epo
is against melanoma. Although ZK-Epo has been studied in the treatment of cancer, it is not
approved for use in treating melanoma. This research is being done because currently there
are only a limited number of treatment options for patients who have melanoma that has spread
to distant organs.
We expect each patient to be in this study for at least 2 cycles. One cycle lasts for 21
days. If their tumor does not grow after 2 cycles and they do not have any major
side-effects, they may receive up to 6 cycles of ZK-Epo.
If after they have received 6 cycles of ZK-Epo and their doctor determines that the tumor is
continuing to shrink, they will continue treatment with ZK-Epo. The number of treatments the
patient receives after 6 cycles will depend upon when their doctor feels there has been
maximum tumor response (tumor shrinkage). Two treatments will be given beyond what their
doctor considers the point of maximum shrinkage. We estimate that they will spend anywhere
from 1 1/2 months to 5 months taking part in this study.
Phase:
Phase 2
Details
Lead Sponsor:
H. Lee Moffitt Cancer Center and Research Institute