A Phase 1/2 Study Of Bosutinib (Ski-606) In Philadelphia Chromosome Positive Leukemias
A Phase 1/2 Study Of Bosutinib (Ski-606) In Philadelphia Chromosome Positive Leukemias
This is an open-label, continuous daily dosing, two-part safety and efficacy study of SKI-606 (bosutinib) in Philadelphia chromosome positive leukemias (Ph+). Part 1 is a dose-escalation study in chronic phase Chronic Myelogenous Leukemia (CML) subjects to establish the maximum tolerated dose (MTD) in this subject population. Part 2 has begun after the completion of Part 1 and after a dose has been established for the compound in chronic phase subjects. Part 2 is a study of the the efficacy of 500mg daily oral SKI-606 (bosutinib) in patients with all phases of Ph+ CML and Ph+ Acute Lymphocytic Leukemia (ALL). The protocol will test the hypotheses that oral daily dosing of bosutinib at 500 mg will attain (1) Major Cytogenetic Response (MCyR) in chronic phase CML patients and (2) Overall Hematological Response (OHR) in advanced leukemia patients. Each phase of the disease will be evaluated as a separate cohort.
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Exclusion Criteria:
Rochester, New York 14642, United States
Pcia de Buenos Aires, Argentina B1629ODT, Argentina
Buenos Aires, 1425, Argentina
Queensland, 4029, Australia
Queensland, 4101, Australia
Jardim Paulista, Sao Paulo/sp - Brazil CEP: 01401-901, Brazil
Santo André, Sp - Brazil CEP 09060-650, Brazil
São Paulo, Sp Brazil 05403-000, Brazil
Zhejiang, P.r China 310003, China
Beijing, P.r. China 100730, China
Shanghai, 200025, China
Bogota, Cundinamarca, Colombia
Toluca Estado de Mexico, CP50180, Mexico
The Netherlands, Netherlands
Kirov, 610027, Russia
Newcastle upon Tyne, North East England NE7 7DN, United Kingdom
University Upon Tyne, North East England NE1 7RU, United Kingdom