1st-line Activity of Dovitinib and Correlation With Genetic Changes in RCC
Status:
Unknown status
Trial end date:
2015-06-01
Target enrollment:
Participant gender:
Summary
The main purpose of this study is to find out how useful dovitinib is when given as the
initial treatment to participants with advanced kidney cancer, that has spread to other parts
of the body. The usefulness of dovitinib will be assessed by: how long the disease is
controlled while participants are receiving the drug, the proportion of participants who get
a reduction in the size of their tumours and how long participants live (both while on
dovitinib and on any subsequent therapy they may receive).
If participants have secondary disease in the bones, the study will evaluate how useful
dovitinib is in controlling this site of disease. In addition, this study will look for
changes in the genetic makeup of tumour cells and see if some of these changes are associated
with a benefit from dovitinib. The study will also compare and contrast the genetic changes
in the primary tumour cells with cells from secondary tumour specimens, and with cells from
tumour specimens taken if a participant's disease has worsened. The purpose of the latter is
to identify possible ways in which the tumour becomes resistant to the study drug.
Phase:
Phase 2
Details
Lead Sponsor:
Auckland District Health Board
Collaborators:
IGENZ, Ltd., Auckland Novartis University of Auckland, New Zealand