None listed
Conditions
Brief 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.
Interventions
Sponsors
Study design
Eligibility
Inclusion criteria
Advanced / metastatic renal cell (clear cell) carcinoma FFPE tumour tissue available for gene status analysis ECOG PS = 1 Adequate organ function
Exclusion criteria
Uncontrolled brain metastases Another primary malignancy < 3 years prior to starting study treatment Prior systemic anticancer treatment Uncontrolled hypertension Impaired cardiac function; clinically significant cardiac disease Concurrent severe and/or uncontrolled concomitant medical conditions