A Randomized Two-by-Two, Multicenter, Open-Label Phase III Study of BMS-354825 Administered Orally at a Dose of 50 mg or 70 mg Twice Daily or 100 mg or 140 mg Once Daily in Subjects With Chronic Phase Philadelphia Chromosome or BCR-ABL Positive Chronic Myelogenous Leukemia Who Are Resistant or Intolerant to Imatinib Mesylate (Gleevec)

CompletadoFase 3ClinicalTrials.gov

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

Traducción no disponible, mostrando original

Resumen

This is a phase III study of BMS-354825 in subjects with chronic phase Philadelphia chromosome or BCR-ABL positive chronic myelogenous leukemia, who are resistant or intolerant to imatinib mesylate (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

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
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

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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