The JET Study: a Phase I Trial of Cabazitaxel, Radiotherapy and Long-term Androgen Deprivation
Status:
Withdrawn
Trial end date:
1969-12-31
Target enrollment:
Participant gender:
Summary
This study utilizes a conventional phase I study design with a '3+3 cohort expansion'
design(15), to determine the maximum tolerated dose(MTD) of 1) Cabazitaxel, in Part A, and 2)
Radiotherapy, in Part B. The determination of the MTD is given in Section 5.2, Definition of
Dose - Limiting Toxicity. All patients who enter the study, and begin concurrent
chemo-radiation are analyzable for the primary endpoint of the study.