EUCTR2007-003624-37-DE进行中（未招募）不适用
Dasatinib in Chronic Myelogenous Leukemia or Philadelphia Chromosome PositiveAcute Lymphoblastic Leukemic Subjects Who are Experiencing Clinical Benefit onCurrent START or CA180039 Protocols: Long Term Safety and Efficacy Analysis.Revised Protocol Number 02 incorporating Administrative Letter 01 and Amendment 03 & 06 (v1.0, dated 24-Nov-2009)
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 313
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •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
排除标准
- •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.
研究者
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