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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
University of Florida
ClinicalTrials.gov Identifier:
NCT01291017
First received: February 1, 2011
Last updated: June 19, 2014
Last verified: June 2014
  Purpose

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 Intervention Phase
Non-small Cell Lung Cancer
Drug: PD0332991
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by University of Florida:

Primary Outcome Measures:
  • Tumor response by direct RECIST measurement [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall Survival [ Time Frame: 14 months ] [ Designated as safety issue: No ]
  • Progression-free survival [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]
    Plasma levels of CDKN2a, CDKS 1,2,4,5, phosphorylated RB, cyclin d1, and E2F in blood

  • Grade of study drug toxicity [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
    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


Enrollment: 19
Study Start Date: February 2011
Estimated Study Completion Date: February 2015
Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PD0332991
PD0332991 125 mg PO days 1 - 21
Drug: PD0332991
PD0332991 125 mg PO days 1 - 21

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01291017

Locations
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
Principal Investigator: Priya Gopalan, MD, PhD University of Florida
  More Information

Additional Information:
No publications provided

Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT01291017     History of Changes
Other Study ID Numbers: PD0332991
Study First Received: February 1, 2011
Last Updated: June 19, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Florida:
Advanced stage

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on October 01, 2014