Cyclin Dependent Kinase (CDK)4/6 Inhibitor, PD0332991 in Advanced Non-small Cell Lung Cancer NSCLC.

University of Florida

Status and phase

Completed

Phase 2

Conditions

Non-small Cell Lung Cancer

Treatments

Drug: PD0332991

Study type

Interventional

Funder types

Other

Identifiers

NCT01291017

PD0332991

Details and patient eligibility

About

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.

Full description

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.

Enrollment

19 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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