Chronic Myelogenous Leukemia or Philadelphia Chromosome Positive Acute Lymphoblastic Leukemic Subjects. MedDRA version: 9.1 Level: LLT Classification code 10009012 Term: Chronic myelogenous leukemia MedDRA version: 9.1 Level: LLT Classification code 10034877 Term: Philadelphia chromosome positive MedDRA version: 9.1 Level: LLT Classification code 10000845 Term: Acute lymphoblastic leukemia
Conditions
Sponsors
Bristol Myers Squibb International Corporation
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Signed Written Informed Consent 2) Target Population (consistent with prior CA180039 and START protocols) a) Treatment on protocols CA180005, CA180006, CA180013, CA180015, CA180017, or CA180039 b) Receiving clinical benefit with dasatinib or imatinib (study CA180017) in the opinion of the Investigator. 3) 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. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1) Sex and Reproductive Status a) 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. b) WOCBP using a prohibited contraceptive method (Not applicable for this study). c) Women who are pregnant or breastfeeding d) Women with a positive pregnancy test on enrollment or prior to investigational product administration. e) 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. 2) Medical History and Concurrent Diseases a) A serious uncontrolled medical disorder or active infection that would impair the ability of the subject to receive protocol therapy b) Dementia or altered mental status that would prohibit the understanding or rendering of informed consent 3) Prohibited Treatments and/or Therapies a) 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 * chloropromazine, haloperidol, mesoridazine, thioridazine, pimozide, zyprasidone * cisapride, bepridil, droperidol, methadone, arsenic, chloroquine, domperidone, halofantrine, levomethadyl, pentamidine, sparfloxacin, lidoflazine b) Subjects taking medications known to be potent CYP3A4 inhibitors (i.e.ketoconazole, ritonavir) or inducers (i.e., rifampin, efavirenz). 4) Other Exclusion Criteria a) Prisoners or subjects who are involuntarily incarcerated b) Subjects who are compulsorily detained for treatment of either a psychiatric or physical (eg, infectious disease) illness Eligibility criteria for this study have been carefully considered to ensure the safety of the study subjects and to ensure that the results of the study can be used. It is imperative that subjects fully meet all eligibility criteria.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is to determine the long term safety and tolerability of dasatinib. ;Secondary Objective: Not applicable;Primary end point(s): Safety In this study, all SAEs, Grade 5 AEs, AEs previously not reported, AEs leading to discontinuation and nonserious AEs of special interest, which include: fluid retention, cardiac events, skin toxicity, hemorrhage, and myelosuppression will be collected. The exception will be in certain countries where all AEs are required to be collected and reported per local regulations. Adverse events will be graded according to the National Cancer Institute’s Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 Efficacy Efficacy analysis will include major molecular response assessments. BCR-ABL transcripts in peripheral blood will be evaluated using real time quantitative polymerase chain reaction (RQ-PCR). Cytogenetic assessments are not required and will be performed at the Investigators' discretion - cytogenetic data will not be collected. | — |
Countries
Belgium, Finland, Germany, Hungary, Ireland, Italy, Spain, United Kingdom
Outcome results
None listed