Dasatinib in Chronic Myelogenous Leukemia or Philadelphia Chromosome Positive Acute Lymphoblastic Leukemic Subjects Who Are Experiencing Clinical Benefit on Current START or CA180-039 Protocols: Long Term Safety and Efficacy Analysis

CompletadoFase 2ClinicalTrials.gov

ID: NCT00982488Tipo: INTERVENTIONALInicio: 1 de oct de 2007Fin estimado: 1 de dic de 2014

Traducción no disponible, mostrando original

Resumen

This study assesses the long-term safety and tolerability of dasatinib administered to patients with chronic myelogenous leukemia or Philadelphia chromosome positive acute lymphoblastic leukemia and experienced clinical benefit from treatment with dasatinib or imatinib in previous protocols.

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

Signed written informed consent
Received treatment in protocols CA180-005, CA180-006, CA180-013, CA180-015 or CA180-017, or CA180-039
Received clinical benefit with dasatinib or imatinib (study CA180017) in the opinion of the Investigator
Men and women, ages 18 and older

Criterios de exclusión

A serious uncontrolled medical disorder or active infection that would impair the ability of the patient to receive protocol therapy
Dementia or altered mental status that would prohibit the understanding or rendering of informed consent
Patients currently taking drugs, 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, and lidoflazine, which are generally accepted to have a risk of causing Torsades de Pointes
Patients taking medications known to be potent CYP3A4 inhibitors (ketoconazole, ritonavir) or inducers (rifampin, efavirenz)

Intervenciones

drug

Dasatinib

Dasatinib was supplied as 20- and 50-mg tablets.

drug

Imatinib

Imatinib was supplied as 100- and 400-mg tablets.

Ubicaciones

Local Institution

Buenos Aires, Buenos Aires, Argentina

Local Institution

Buenos Aires, Buenos Aires, Argentina

Local Institution

Capital Federal, Buenos Aires, Argentina

Patrocinadores

PrincipalBristol-Myers Squibb

Aviso: La información de este ensayo proviene de fuentes públicas y tiene carácter exclusivamente informativo. No constituye asesoramiento médico, regulatorio ni de ningún otro tipo. Las traducciones son automatizadas y no poseen validez oficial. Consultá siempre con un profesional de la salud. Ver Términos de Uso.

Dasatinib in Chronic Myelogenous Leukemia or Philadelphia... | EligiMed