Cyclin Dependent Kinase (CDK)4/6 Inhibitor, PD0332991 in Advanced Non-small Cell Lung Cancer NSCLC.
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.
Ask AI to explain this studyKey things to know
This describes the study’s primary purpose.
The study team can explain what participation involves.
These are broad labels—not an eligibility decision.
Checked against the public recordLast updated May 13, 2016 · Source: ClinicalTrials.gov
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Interventional
Locations may change over time.
Study sponsor
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 2
- Sponsor
- University of Florida
- Interventions being studied
- Drug: PD0332991
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.
- 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
- 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
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- UF Health Cancer CenterGainesville, Florida
- H. Lee Moffitt Cancer and Research InstituteTampa, Florida
Source and freshness
Processed from ClinicalTrials.gov. Last public update: May 13, 2016. Always confirm current availability with the study team.