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
|
- Study Details
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Non-small Cell Lung Cancer | Drug: PD0332991 | Phase 2 |
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 |

Arm | Intervention/treatment |
---|---|
Experimental: PD0332991
PD0332991 125 mg PO days 1 - 21
|
Drug: PD0332991
PD0332991 125 mg PO days 1 - 21
Other Name: Palbociclib |
- 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.
- 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.

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, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

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
United States, Florida | |
UF Health Cancer Center | |
Gainesville, Florida, United States, 32610 | |
H. Lee Moffitt Cancer and Research Institute | |
Tampa, Florida, United States, 33612 |
Principal Investigator: | Priya Gopalan, MD, PhD | University of Florida |
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 |
Advanced stage |
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 |