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

NCT ID: NCT01291017

Last Updated: 2016-05-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 19 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-02-28
• Study Completion Date: 2015-02-28

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.

Conditions

Non-small Cell Lung Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

PD0332991

PD0332991 125 mg PO days 1 - 21

Group Type: EXPERIMENTAL

PD0332991

Intervention Type: DRUG

PD0332991 125 mg PO days 1 - 21

Interventions

PD0332991

PD0332991 125 mg PO days 1 - 21

Intervention Type: DRUG

Other Intervention Names

Palbociclib

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Florida

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Priya Gopalan, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Florida

Locations

UF Health Cancer Center

Gainesville, Florida, United States

H. Lee Moffitt Cancer and Research Institute

Tampa, Florida, United States

Countries

United States

Related Links

http://cancer.ufl.edu/

UF Health Cancer Center

Other Identifiers

PD0332991

Identifier Type: -

Identifier Source: org_study_id