Study of Dasatinib and All-Trans Retinoic Acid for Relapsed/Refractory and/or Elderly Patients With Acute Myelogenous Leukemia (AML) or Myelodysplastic Syndrome

Who cannot join

• Sex and Reproductive Status: WOCBP who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for at least 4 weeks after the last dose of study drug. Women who are pregnant or breastfeeding. Women with a positive pregnancy test. Sexually active fertile men not using effective birth control if their partners are WOCBP.
• Target Disease Exceptions: Subjects with a diagnosis of Acute Promyelocytic Leukemia, Known or clinically suspected CNS involvement, HIV Positivity, A diagnosis of another active malignancy with the exception of non-melanoma skin cancer or cervical cancer in situ., Gastrointestinal conditions that could affect drug absorption including post surgical states such as gastric bypass, History of psychiatric disorder which may compromise compliance, Stem cell transplant within 60 days., Subjects who have undergone stem cell transplant who are undergoing treatment or prophylaxis for Graft versus host disease
• Medical History and Concurrent Diseases: Concurrent medical condition which may increase the risk of toxicity, including: Pleural or pericardial effusion of any grade, Cardiac Symptoms; any of the following will be considered for exclusion: Uncontrolled angina, congestive heart failure or 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 QTc interval on pre-entry electrocardiogram (> 470 msec), Subjects with hypokalemia or hypomagnesemia if it cannot be corrected prior to dasatinib administration
• Physical and Laboratory Test Findings: Chronic diarrhea, Uncontrolled, life-threatening infection that is not responding to antimicrobial therapy
• Allergies and Adverse Drug Reactions: History of allergic reaction to ATRA, History of allergic reaction to dasatinib
• Prohibited Treatments and/or Therapies: Category I drugs that are generally accepted to have a risk of causing Torsades de Pointes or prolonge QT interval including: (Patients must discontinue drug 7 days prior to starting dasatinib) (See section 5.6.1.2) 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, azithromycin, citalopram, escitalopram, flecainide, mesoridazine, sevoflurane. Potent inhibitors of CYP3A4 (see section 5.6.1.1 for more details). Proton pump inhibitors and H2 inhibitors (see section 5.6.2.3). St. John's Wort (see section 5.6.2.4). Medications that inhibit platelet function and anticoagulants (see section 5.6.2.5). Currently receiving anticancer therapy. Use of hydroxyurea within 7 days prior to screening labs. Treatment with a an investigational agent within 30 days prior to the first dose of dasatinib/ATRA or planning to receive an investigational agent during the study. Growth factors within 14 days prior to screening labs
• Other Exclusion Criteria: Prisoners, or subjects who are involuntarily incarcerated. Subjects who are compulsorily detained for treatment of either a psychiatric or physical (eg, infectious disease) illness.