The purpose of this study is to determine the efficacy and the toxicities of the study drug PD0332991 in the treatment of patients with Stage IV non-small cell lung cancer with wildtype retinoblastoma protein (RB) and inactivated cyclin dependent kinase (CDK) N2A in the tumor.
The oral drug PD0332991 is a highly selective reversible inhibitor of cyclin-dependent kinases 4 \& 6 that is being studied for use in the treatment of advanced non-small cell lung cancer.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
19
PD0332991 125 mg PO days 1 - 21
UF Health Cancer Center
Gainesville, Florida, United States
H. Lee Moffitt Cancer and Research Institute
Tampa, Florida, United States
Tumor Response by Direct RECIST Measurement
Response is a decrease in the sum of the longest diameters of the target lesions by more than 30% compared to the baseline.
Time frame: 6 months
Overall Survival
Median overall survival
Time frame: 14 months
Progression-free Survival
Median progression-free survival.
Time frame: 12 months
Plasma Levels
Plasma levels of p16, phosphorylated RB and cyclin d1 in blood.
Time frame: 6 months
Grade of Study Drug Toxicity
The number of all toxicities and grades 3 and 4 (per CTCAE v3.0) toxicities that occured during the administration of the drug and during the follow up period.
Time frame: 24 months
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