Cyclin Dependent Kinase (CDK)4/6 Inhibitor, PD0332991 in Advanced Non-small Cell Lung Cancer NSCLC.
Condition: Non-small Cell Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Intervention: PD0332991
Intervention description: PD0332991 125 mg PO days 1 - 21
Intervention MeSH terms: Palbociclib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 19.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Advanced stage

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.
    

Eligibility 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