Research and Clinical Trials

Brief Description  
The primary purpose of this is study is to evaluate the progression-free survival (PFS) using Imetelstat as maintenance therapy for patients with advanced non-small cell lung cancer (NSCLC) who received previous treatment with four cycles of standard chemotherapy with or without Bevacizumab and did not have tumor progression. The study will compare treatment with Imetelstat plus standard of care (Bevacizumab or observation alone are both considered standard of care) versus standard of care alone
Who may be Eligible  

KEY INCLUSION
  • Male or female, age 18 or over.
  • Histologically or cytologically confirmed diagnosis of NSCLC
  • Stage IIIb with pleural effusion, Stage IV, or recurrent disease
  • Patients have completed four cycles of platinum-based chemotherapy doublet for first line, advanced NSCLC, with no evidence of disease progression. Adjuvant chemotherapy greater than one year prior to progression is allowed.
  • Patients are willing and able to continue treatment with Bevacizumab, if they received it with their platinum based chemotherapy based.
  • ECOG performance status 0-1
  • No other obvious related major organ toxicities which would compromise the patient’s ability to participate in a clinical trial of a novel agent.
  • Patients may have received prior radiation therapy for local or locally advanced disease providing that any clinically significant adverse effects associated with prior therapy have recovered.

Exclusion Criteria:

  • Patients receiving Bevacizumab must not have a history of hemoptysis or squamous cell histology, or urinary protein
  • History of pulmonary hemorrhage (> 1 teaspoon) within the previous 4 weeks
  • Active central nervous system (CNS) metastatic disease. Patients with stable CNS disease following completion of radiation therapy and/or surgery are eligible.
  • Any other active malignancy
  • Active or chronically recurrent bleeding (for example, peptic ulcer disease)
  • Clinically significant cardiovascular disease or condition including:
    • Congestive heart failure (CHF) requiring therapy
    • Need for antiarrhythmic therapy for a ventricular arrhythmia
    • Severe conduction disturbance
    • Angina pectoris requiring therapy
    • Medically uncontrolled hypertension per the Investigator’s discretion
    • Myocardial infarction within 6 months prior to first study drug administration
    • New York Heart Association Class II, III, or IV cardiovascular disease
Speciality/Disorder  
Non-small cell lung cancer (NSCLC)
IRB Number  
07-10-05A
Principal Investigator  
Carrizosa, Daniel

For More Information, Contact  Mary  K, Tipton
Phone:  (704) 355-8289  Fax:  (704) 355-1353  
Email:  mary.tipton@carolinashealthcare.org
Address:1100 South Tryon Street Suite 220 Charlotte, NC 28204
Close