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

• Status: Completed
• Trial end date: 2015-02-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Florida
• Treatments: Palbociclib

Criteria

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