Estudio de fase III, aleatorizado, dos por dos, multicént... | EligiMed

Estudio de fase III, aleatorizado, dos por dos, multicéntrico, abierto, de BMS-354825 administrado por vía oral a una dosis de 50 mg o 70 mg dos veces al día o de 100 mg o 140 mg una vez al día en sujetos con leucemia mieloide crónica en fase crónica con cromosoma Filadelfia positivo o BCR-ABL positivo resistentes o intolerantes a mesilato de imatinib (Gleevec)

CompletadoFase 3ClinicalTrials.gov

ID: NCT00123474Tipo: INTERVENTIONALInicio: 1 de jul de 2005Fin estimado: 1 de jul de 2014

Resumen

Se trata de un estudio de fase III de BMS-354825 en sujetos con leucemia mieloide crónica en fase crónica con cromosoma Filadelfia positivo o BCR-ABL positivo, resistentes o intolerantes a mesilato de imatinib (Gleevec).

Elegibilidad

Edad mínima: 18 YearsEdad máxima: 90 YearsSexo: ALL

Criterios de inclusión

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com.
Subjects with Philadelphia chromosome positive (Ph+) (or BCR/ABL+) chronic phase chronic myeloid leukemia whose disease has primary or acquired hematologic resistance to imatinib mesylate or who are intolerant of imatinib mesylate.
Men and women, 18 years or older
Adequate hepatic function
Adequate renal function
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 before and at least 3 months after the study in such a manner that the risk of pregnancy is minimized.

Criterios de exclusión

Women who are pregnant or breastfeeding
Subjects who are eligible and willing to undergo transplantation during the screening period
A serious uncontrolled medical disorder or active infection that would impair the ability of the subject to receive protocol therapy
Uncontrolled or significant cardiovascular disease
Medications that increase bleeding risk
Medications that change heart rhythms
Dementia or altered mental status that would prohibit the understanding or rendering of informed consent
History of significant bleeding disorder unrelated to CML
Concurrent incurable malignancy other than CML
Evidence of organ dysfunction or digestive dysfunction that would prevent administration of study therapy
Prisoners or subjects who are compulsorily detained (involuntarily incarcerated) for treatment of either a psychiatric or physical (e.g., infectious disease) illness must not be enrolled into this study

Intervenciones

drug

dasatinib

Tablets, Oral, 50 mg BID, indefinitely, survival study

drug

dasatinib

Tablets, Oral, 70 mg BID, indefinitely, survival study

drug

dasatinib

Tablets, Oral, 100 mg QD, indefinitely, survival study

drug

dasatinib

Tablets, Oral, 140 mg QD, indefinitely, survival study

Ubicaciones

Local Institution

La Plata, Buenos Aires, Argentina

Local Institution

Buenos Aires, Argentina

Local Institution

Capital Federal, Argentina

Local Institution

Córdoba, Argentina

Patrocinadores

PrincipalBristol-Myers Squibb

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