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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


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Non-small Cell Lung Cancer

Thank you

Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Tumor response by direct RECIST measurement

Outcome Time Frame:

6 months

Safety Issue:

No

Principal Investigator

Priya Gopalan, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Florida

Authority:

United States: Food and Drug Administration

Study ID:

PD0332991

NCT ID:

NCT01291017

Start Date:

February 2011

Completion Date:

February 2015

Related Keywords:

  • Non-Small Cell Lung Cancer
  • Advanced stage
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

Name

Location

University of Florida Shands Cancer CenterGainesville, Florida  32610-0232
H. Lee Moffitt Cancer and Research InstituteTampa, Florida  33612