NCT01291017

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
19

participants targeted

Target at below P25 for phase_2 nonsmall-cell-lung-cancer

Timeline
Completed

Started Feb 2011

Typical duration for phase_2 nonsmall-cell-lung-cancer

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 1, 2011

Completed
Same day until next milestone

Study Start

First participant enrolled

February 1, 2011

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 7, 2011

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2014

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2015

Completed
4 months until next milestone

Results Posted

Study results publicly available

May 21, 2015

Completed
Last Updated

May 13, 2016

Status Verified

April 1, 2016

Enrollment Period

3 years

First QC Date

February 1, 2011

Results QC Date

March 12, 2015

Last Update Submit

April 8, 2016

Conditions

Non-small Cell Lung Cancer

Keywords

Advanced stage

Outcome Measures

Primary Outcomes (1)

  • Tumor Response by Direct RECIST Measurement

    Response is a decrease in the sum of the longest diameters of the target lesions by more than 30% compared to the baseline.

    6 months

Secondary Outcomes (4)

  • Overall Survival

    14 months

  • Progression-free Survival

    12 months

  • Plasma Levels

    6 months

  • Grade of Study Drug Toxicity

    24 months

Study Arms (1)

PD0332991

EXPERIMENTAL

PD0332991 125 mg PO days 1 - 21

Drug: PD0332991

Interventions

PD0332991DRUG

PD0332991 125 mg PO days 1 - 21

Also known as: Palbociclib
PD0332991

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

UF Health Cancer Center

Gainesville, Florida, 32610, United States

Location

H. Lee Moffitt Cancer and Research Institute

Tampa, Florida, 33612, United States

Location

Related Links

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

palbociclib

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Results Point of Contact

Title
Priya K Gopalan, MD
Organization
University of Florida
gopalpk@ufl.edu
352-273-8699

Study Officials

  • Priya Gopalan, MD, PhD

    University of Florida

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 1, 2011

First Posted

February 7, 2011

Study Start

February 1, 2011

Primary Completion

February 1, 2014

Study Completion

February 1, 2015

Last Updated

May 13, 2016

Results First Posted

May 21, 2015

Record last verified: 2016-04

Locations

US(2)