Clinical trial NCT00564876 (phase 2, status: terminated)
Conditions: carcinoma, non-small-cell lung
ICD codes: D02.20, D02.21, D02.22
Drugs: dasatinib
SMILES: CC1=NC(NC2=NC=C(S2)C(=O)NC2=C(C)C=CC=C2Cl)=CC(=N1)N1CCN(CCO)CC1
Reason stopped: 
    lack of accrual, study closed.
  
Eligibility criteria:

        Inclusion Criteria:

          -  Suspected or histological/cytological diagnosis of Non-Small Cell Lung Cancer (NSCLC),
             Stage IB (≥4 cm per CT) or Stage IIA or IIB, amenable to surgical resection

          -  Must be deemed a surgical candidate

          -  Tumors ≥2 cm in maximum diameter without radiographic, bronchoscopic or pathologic
             evidence of nodal metastases are eligible for biopsy

          -  Fresh tissue biopsy material must be available for genomics analysis prior to
             initiating dasatinib therapy

          -  Age ≥18 years

          -  Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2

          -  No prior chemotherapy, immunotherapy, radiation therapy or biologic/targeted therapy
             for any malignancy

          -  Adequate Organ Function:

               -  Total bilirubin <institutional upper limit normal (ULN)

               -  Hepatic enzymes (AST, ALT) ≤2.5x institutional ULN

               -  Serum creatinine <1.5x institutional ULN

               -  Hemoglobin ≥9 gm/dL

               -  Neutrophil count (ANC or AGC) ≥1500 per μL

               -  Platelets ≥100,000 per μL

               -  Prothrombin time (PT)/a partial thromboplastin time (PTT) ≤1.5x control

          -  No other serious medical or psychiatric illness

          -  Ability to take oral medication (dasatinib must be swallowed whole)

          -  Women of childbearing potential (WOCBP) must have a negative serum pregnancy test
             preferably within 72 hours and no later than 7 days, prior to the start of study drug
             administration

          -  Both sexually active males and females of reproductive potential must agree to use an
             adequate method of contraception throughout treatment and for at least 4 weeks after
             study drug is stopped

          -  Signed written informed consent including Health Insurance Portability and
             Accountability Act (HIPAA) according to institutional guidelines

        Exclusion Criteria:

          -  Previous or concomitant malignancy in the past 2 years other than curatively treated
             carcinoma in situ of the cervix, basal cell or squamous cell carcinoma of the skin

          -  Prior dasatinib therapy

          -  Evidence of pleural or pericardial effusion of any grade

          -  Cardiac Symptoms:

               -  Uncontrolled angina, congestive heart failure (CHF), or myocardial infarction
                  (MI) within 6 months

               -  Diagnosed congenital long QT syndrome

               -  Any history of clinically significant ventricular arrhythmias (such as
                  ventricular tachycardia, ventricular fibrillation, or Torsades de Pointes)

               -  Prolonged QT corrected (QTc) interval on pre-entry EKG (>450 msec)

               -  Uncontrolled hypertension defined as >160/90 on a regimen of antihypertensive
                  therapy

          -  Subjects with hypokalemia or hypomagnesaemia if it cannot be corrected

          -  History of diagnosed congenital acquired bleeding disorders (e.g., von Willebrand's
             disease)

          -  Ongoing or recent (≤3 months) significant (≥grade 3) gastrointestinal bleeding

          -  Concomitant Medications:

               -  Drugs that are generally accepted to have a risk of causing Torsades de Pointes
                  including: (Patients must discontinue drug 7 days prior to starting dasatinib)

                  **quinidine, procainamide, disopyramide, amiodarone, sotalol, ibutilide,
                  dofetilide, erythromycin, clarithromycin, chlorpromazine, haloperidol,
                  mesoridazine, thioridazine, pimozide, cisapride, bepridil, droperidol, methadone,
                  arsenic, chloroquine, domperidone, halofantrine, levomethadyl, pentamidine,
                  sparfloxacin, lidoflazine

               -  Current therapeutic dose heparin or coumadin therapy

               -  St. John's Wort and all herbal supplements must be stopped while on dasatinib

               -  IV bisphosphonates will be withheld for 2 weeks prior and 6 weeks after dasatinib
                  administration due to risk of hypocalcaemia

          -  Prisoners or subjects who are compulsorily detained (involuntarily incarcerated) for
             treatment of either a psychiatric or physical (e.g., infectious) illness

          -  Pregnant or breastfeeding

          -  Active or uncontrolled infection requiring intravenous antibiotics

          -  Impairment of gastrointestinal (GI) function or GI disease that may significantly
             alter the absorption of dasatinib (e.g., ulcerative diseases, uncontrolled nausea,
             vomiting, diarrhea, malabsorption syndrome, or small bowel resection)

          -  Patients who have received investigational drugs ≤4 weeks prior to starting study drug
             and/or who have not recovered from side effects of such therapy