Title
|
Enzalutamide efficacy (part 1) |
Number of Patients Enrolled
|
16 |
Number of Patients Evaluable for Toxicity
|
16 |
Number of Patients Evaluated for Efficacy
|
15 |
Evaluation Method
|
RECIST 1.1 |
Response Assessment CR
|
n = 0 (0%) |
Response Assessment PR
|
n = 0 (0%) |
Response Assessment SD
|
n = 7 (44%) |
Response Assessment PD
|
n = 8 (50%) |
Response Assessment OTHER
|
n = 1 (6%) |
(Median) Duration Assessments PFS
|
1.76 months, CI: 1.61–3.55 |
(Median) Duration Assessments OS
|
7.03 months, CI: 3.55–NR |
Outcome Notes
|
One patient did not complete 80% of dosing in cycle 1 and was replaced for DLT per protocol. The patient clinically deteriorated on study and was evaluable for toxicity and survival but not for response. |