Title
|
Overall Response Rate |
Number of Patients Screened
|
21 |
Number of Patients Enrolled
|
21 |
Number of Patients Evaluable for Toxicity
|
21 |
Number of Patients Evaluated for Efficacy
|
17 |
Evaluation Method
|
RECIST version 1.1 |
Response Assessment CR
|
n = 0 (0%) |
Response Assessment PR
|
n = 0 (0%) |
Response Assessment SD
|
n = 5 (29%) |
Response Assessment PD
|
n = 12 (71%) |
(Median) Duration Assessments PFS
|
1.8 months; confidence interval, 1.1–4.9 |
(Median) Duration Assessments OS
|
3.0 months; confidence interval, 1.9–6.6 |
Outcome Notes
|
|
Overall response rate and progression‐free survival were assessed using RECIST criteria version 1.1. Subjects were assessed at baseline and approximately every 9 weeks (±4 days) from the first dose of palbociclib until documented progression or withdrawal from the study. |