Dasatinib in Chronic Myelogenous Leukemia or Philadelphia Chromosome Positive Acute Lymphoblastic Leukemic Subjects Who are Experiencing Clinical Benefit on Current START Protocols: Long Term Safety and Efficacy Analysis - ND

• Conditions: Chronic Myelogenous Leukemia or Philadelphia Chromosome Positive Acute Lymphoblastic Leukemic Subjects; MedDRA version: 9.1Level: HLGTClassification code 10024324Term: Leukaemias

• Registration Number: EUCTR2007-003624-37-IT
• Lead Sponsor: Bristol Myers Squibb International Corporation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-10-25
• Last Update Posted: 16 November 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 313

Inclusion Criteria

1) Signed Written Informed Consent 2) Target Population (consistent with prior START protocols) a) Treatment on protocols CA180005, CA180006, CA180013, CA180015 or CA180017. 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

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified