A Dose Finding Clinical Trial of Cabozantinib (XL 184) Administered in Combination With Abiraterone in Castration Resistant Prostate Cancer
The following procedures will be performed during this study. On Day 1 for every cycle (28
days/4 weeks)-The following will be undertaken prior to initiating study therapy and on day
1 of every subsequent cycle: A medical history, physical exam, performance status, blood
tests, urine test.
Since we are looking for the highest dose of the study drug that can be administered safely
without severe or unmanageable side effects in participants, not everyone who participates
in this research study will receive the same dose of the study drug. The dose you get will
depend on the number of participants who have been enrolled in the study before you and how
well they have tolerated their doses.
We will actively monitor your condition for up to 30 days after you come off the study. If
you come off study for a side effect we will monitor your condition until the resolution or
stabilization of the side effect
Interventional
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Maximum Tolerated Dose
To define the MTD of cabozantinib in combination with abiraterone
2 years
Yes
United States: Food and Drug Administration
11-441
NCT01574937
September 2012
April 2014
Name | Location |
---|---|
Beth Israel Deaconess Medical Center | Boston, Massachusetts 02215 |
Dana-Farber Cancer Institute | Boston, Massachusetts 02115 |
Brigham and Women's Hospital | Boston, Massachusetts 02115 |
Massahcusetts General Hospital | Boston, Massachusetts 02115 |