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

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ClinicalTrials.gov Identifier: NCT01291017
Recruitment Status : Completed
First Posted : February 7, 2011
Results First Posted : May 21, 2015
Last Update Posted : May 13, 2016
Sponsor:
Information provided by (Responsible Party):
University of Florida

Tracking Information
First Submitted Date  ICMJE February 1, 2011
First Posted Date  ICMJE February 7, 2011
Results First Submitted Date  ICMJE March 12, 2015
Results First Posted Date  ICMJE May 21, 2015
Last Update Posted Date May 13, 2016
Study Start Date  ICMJE February 2011
Actual Primary Completion Date February 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 4, 2015)
Tumor Response by Direct RECIST Measurement [ Time Frame: 6 months ]
Response is a decrease in the sum of the longest diameters of the target lesions by more than 30% compared to the baseline.
Original Primary Outcome Measures  ICMJE
 (submitted: February 4, 2011)
Tumor Response by Direct RECIST Measurement [ Time Frame: 6 months ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 4, 2015)
  • Overall Survival [ Time Frame: 14 months ]
    Median overall survival
  • Progression-free Survival [ Time Frame: 12 months ]
    Median progression-free survival.
  • Plasma Levels [ Time Frame: 6 months ]
    Plasma levels of p16, phosphorylated RB and cyclin d1 in blood.
  • Grade of Study Drug Toxicity [ Time Frame: 24 months ]
    The number of all toxicities and grades 3 and 4 (per CTCAE v3.0) toxicities that occured during the administration of the drug and during the follow up period.
Original Secondary Outcome Measures  ICMJE
 (submitted: February 4, 2011)
  • Overall Survival [ Time Frame: 14 months ]
  • Progression-free Survival [ Time Frame: 12 months ]
    Duration of time from start of treatment to time of progression or death
  • Type of study drug toxicities based on adverse events [ Time Frame: 24 months ]
    Type of study drug related toxicities based on adverse events that are documented during and after the study drug.
  • Plasma Levels [ Time Frame: 6 months ]
    Plasma levels of CDKN2a, CDKS 1,2,4,5, phophorylated RB, cyclin d1, and E2F in blood
  • Grade of Study Drug Toxicity [ Time Frame: 24 months ]
    Document the grade of each toxicity that is related to the study drug during the administration of the drug and during the follow up period
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Cyclin Dependent Kinase (CDK)4/6 Inhibitor, PD0332991 in Advanced Non-small Cell Lung Cancer NSCLC.
Official Title  ICMJE A Phase II Clinical Trail of the Cyclin Dependent Kinase (CDK)4/6 Inhibitor, PD0332991 in Previously Treated, Advanced NSCLC Patients With Wildtype Retinoblastoma Protein (RB) and Inactive Cyclin Dependent Kinase (CDK)N2a
Brief 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.
Detailed 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Non-small Cell Lung Cancer
Intervention  ICMJE Drug: PD0332991
PD0332991 125 mg PO days 1 - 21
Other Name: Palbociclib
Study Arms  ICMJE Experimental: PD0332991
PD0332991 125 mg PO days 1 - 21
Intervention: Drug: PD0332991
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 19, 2014)
19
Original Estimated Enrollment  ICMJE
 (submitted: February 4, 2011)
48
Actual Study Completion Date  ICMJE February 2015
Actual Primary Completion Date February 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01291017
Other Study ID Numbers  ICMJE PD0332991
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of Florida
Study Sponsor  ICMJE University of Florida
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Priya Gopalan, MD, PhD University of Florida
PRS Account University of Florida
Verification Date April 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP