START Rollover Study

Chronic Myelogenous Leukemia or Philadelphia Chromosome Positive Acute Lymphoblastic Leukemic Subjects who were previously enrolled and treated with dasatinib or imatinib in the START or CA180039 protocols who are experiencing clinical benefit. The primary objective is to determine the long term safety and tolerability of treatment with dasatinib

• Drug: Dasatinib
  Tablets, Oral, 20mg BID/40mg QD to maximum 100 mg BID/180 mg QD to achieve maximum clinical benefit QD or BID dosing Subjects will be treated until progression of disease despite escalation of dose to the highest level deemed safe by available data, until intolerable/unacceptable toxicity or until subject withdrawal from the study or discontinuation of the study
  Other Names:

  • BMS-354825
  • Sprycel
  • Src Kinase
• Drug: Imatinib
  Tablets, Oral, 300 or 400 mg, BID, Subjects will be treated until disease progression, intolerable/unacceptable toxicity or until the subject withdrawal from the study or discontinuation of the study
  Other Name: Gleevec/Glivec

• Dasatinib
  Dependent upon previous dosing from START or CA180-039 trials
  Intervention: Drug: Dasatinib
• Imatinib
  Dependent upon previous dosing from START or CA180-039 trials
  Intervention: Drug: Imatinib

Inclusion Criteria:

• Signed Written Informed Consent

• Target Population (consistent with prior CA180039 and START protocols)

  • Treatment on protocols CA180-005, CA180-006, CA180-013, CA180-015 or CA180-017, or CA180-039
  • Receiving clinical benefit with dasatinib or imatinib (study CA180017) in the opinion of the Investigator
• Age and Sex
• Men and women, ages 18 and older may participate
• Women of childbearing potential (WOCBP) must be using an adequate method of contraception to avoid pregnancy throughout the study and for a period of at least 1 month (4 weeks) before and at least 3 months (12 weeks) after the last dose of investigational product in such a manner that risk of pregnancy is minimized

Exclusion Criteria:

• 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 one month (4 weeks) before and for at least 3 months (12 weeks) after the last dose of study medication
• Women who are pregnant or breastfeeding
• Women with a positive pregnancy test on enrollment or prior to investigational product administration
• Sexually active fertile men whose sexual partner(s) are WOCBP, who are unwilling or unable to use an effective method to avoid pregnancy for the entire study period and for at least 3 months (12 weeks) after completion of study medication

• Medical History and Concurrent Diseases

  • A serious uncontrolled medical disorder or active infection that would impair the ability of the subject to receive protocol therapy
  • Dementia or altered mental status that would prohibit the understanding or rendering of informed consent

• Prohibited Treatments and/or Therapies

  • Subjects currently taking drugs that are generally accepted to have a risk of causing Torsades de Pointes including, but not limited to:

    • quinidine, procainamide, disopyramide
    • amiodarone, sotalol, ibutilide, dofetilide
    • erythromycins, clarithromycin
    • chlorpromazine, haloperidol, mesoridazine, thioridazine, pimozide, ziprasidone
    • cisapride, bepridil, droperidol, methadone, arsenic, chloroquine, domperidone, halofantrine, levomethadyl, pentamidine, sparfloxacin, lidoflazine
  • Subjects taking medications known to be potent CYP3A4 inhibitors (i.e., ketoconazole, ritonavir) or inducers (i.e., rifampin, efavirenz)