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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Study Description
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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.

Condition or disease Intervention/treatment Phase
Non-small Cell Lung Cancer Drug: PD0332991 Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 19 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : February 2011
Actual Primary Completion Date : February 2014
Actual Study Completion Date : February 2015

Resource links provided by the National Library of Medicine

Drug Information available for: Palbociclib

Arms and Interventions
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Arm Intervention/treatment
Experimental: PD0332991
PD0332991 125 mg PO days 1 - 21
 Drug: PD0332991
PD0332991 125 mg PO days 1 - 21
Other Name: Palbociclib


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Overall Survival [ Time Frame: 14 months ]
    Median overall survival

  2. Progression-free Survival [ Time Frame: 12 months ]
    Median progression-free survival.

  3. Plasma Levels [ Time Frame: 6 months ]
    Plasma levels of p16, phosphorylated RB and cyclin d1 in blood.

  4. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01291017


Locations
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United States, Florida
UF Health Cancer Center
Gainesville, Florida, United States, 32610
H. Lee Moffitt Cancer and Research Institute
Tampa, Florida, United States, 33612
Sponsors and Collaborators
University of Florida
Investigators
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Principal Investigator: Priya Gopalan, MD, PhD University of Florida
More Information
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Additional Information:

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Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT01291017    
Other Study ID Numbers: PD0332991
First Posted: February 7, 2011    Key Record Dates
Results First Posted: May 21, 2015
Last Update Posted: May 13, 2016
Last Verified: April 2016
Keywords provided by University of Florida:
Advanced stage
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
 Carcinoma, Bronchogenic
Bronchial Neoplasms
Palbociclib
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action