Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
University of Florida
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.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Histologically or cytologically proven non small cell lung cancer
Stage IV (M1a or M1b) disease. Patients may also have recurrence of early-stage disease or locally advanced disease with the presence of new distant metastases.
Cyclin dependent kinase (CDK)N2a (p16) protein absent or expressed at a low level in tumor biopsy specimen
Failed or intolerant of at least one prior systemic chemotherapy regimen (there is no maximum number of prior chemotherapy regimens)
Eastern cooperative oncology group (ECOG) performance status 0-2
Age \>18 years.
Adequate organ and bone marrow function
Measurable disease by standard RECIST v1.1 criteria
Life expectancy of greater than 3 months
You may not be if
Inability to understand or sign the informed consent document
Inability or unwillingness to take oral medications
No available tissue specimen for p16 analysis
Chemotherapy or radiotherapy within 3 weeks prior to beginning the study drug
Other investigational agents within 4 weeks prior to beginning the study drug
All side effects from previous chemotherapy, radiotherapy or investigational agents not resolved, returned to baseline or returned to Grade 1 toxicity (exceptions are grade 2 alopecia and grade 2 peripheral neuropathy)
Major surgery within 4 weeks prior to beginning the study drug
Surgical scar from previous surgery not healed prior to beginning the study drug
High-dose or chronic steroid use
High-dose statins within 7 days
History of rhabdomyolysis
Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, uncontrolled diabetes, stroke or myocardial infarction within 3 months, or psychiatric illness/social situations that would limit compliance with study requirements.
Baseline corrected QT interval (QTc) \>470ms
Pre-existing clinically significant cardiac, hepatic or renal dysfunction at the discretion of the treating physician
Untreated or uncontrolled (symptomatic or asymptomatic) brain metastases
Leptomeningeal carcinomatosis
Inability or unwillingness to use contraception during the treatment period by patients with reproductive potential.
Pregnant or breastfeeding women
HIV-positive patients on combination antiretroviral therapy
Clareo Health | Cyclin Dependent Kinase (CDK)4/6 Inhibitor, PD0332991 in Advanced Non-small Cell Lung Cancer NSCLC.
