None listed
Conditions
Interventions
BRANCH 1 Type of group
This group will be treated with BMS-354825 50 mg BID PO until progression of the disease or adverse events.
Group name:BRANCH 4 Type of group
This group will be treated with BMS-354825 140 mg QD PO until progression of the disease or adverse events.
Sponsors
BRISTOL MYERS SQUIBB COMPANY,
Eligibility
Inclusion criteria
Inclusion criteria: 1) Patient agrees to participate in the study and signs informed consent. 2) Subjects with a myeloproliferative disorder defined as Ph + (or BCR / ABL +) CML in CF, whose disease has primary or acquired hematologic resistance to imatinib mesylate, or are intolerant to imatinib mesylate. 3) Score of 0 - 2 in the performance status (PS) ECOG. 4) Adequate liver function. 5) Adequate renal function. 6) Serum levels of Na, K, Mg, P and levels of total serum Ca or ionized Ca should be greater than or equal to the lower normal institutional limit. 7) Men and women 18 years of age or older. 8) Women of childbearing age (FEM) should use a method of birth control that is appropriate. 9) Women of childbearing age must present a negative result in the pregnancy test performed in serum or urine.
Exclusion criteria
Exclusion criteria: 1) MEF that are not willing or able to use a method of birth control that is acceptable. 2) MEF who are using a prohibited contraceptive method. 3) Women who are pregnant or breastfeeding. 4) Women who have obtained a positive result in the pregnancy test. 5) Sexually active men whose sexual partners are MEF, who are unwilling or unable to use a method that is acceptable. 6) Subjects that are eligible for an immediate autologous or allogeneic stem cell transplant. 7) Severe uncontrolled medical disorder or active infection. 8) Significant or uncontrolled cardiovascular disease. 9) History of significant hemorrhagic disorder not associated with CML. 10) Concurrent incurable neoplasia different from CML. 11) Dementia or mental state altered. 12) Evidence of organic dysfunction or digestive dysfunction. 13) Subjects who received any of the following: a) Imatinib mesylate in the 7 days prior to admission. b) Interferon or cytarabine in the 7 days prior to admission. c) A small target antineoplastic molecule within 7 days prior to admission. d) Any investigational or other neoplastic drug. 14) Subjects who are currently taking drugs that are generally accepted that there is a risk that they cause Torsade de Pointes. 15) Subjects who are taking drugs that inhibit platelet function irreversibly. 16) Prisoners or patients who are detained against their will can not be enrolled in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Bone marrow samples, with metaphase cells that are Ph + in a percentage of 0-35% (RCym). Measure:Primary efficacy: Rate of RCym (Major cytogenetic response). Timepoints:Before treatment, in months 1, 2 and 3. Subsequently every 3 months until year 2 and at the end of treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Bone marrow samples, with metaphase cells that are Ph + in a percentage of 0-35% (RCym). Complete blood count. Survival analysis. Measure:Secondary efficacy: rate of RHC, the time that passes to RCyM and RHC and their duration, the PFS and the global survival. Timepoints:Bone marrow samples: Before treatment, in months 1, 2 and 3. Subsequently every 3 months until year 2 and at the end of treatment. Before treatment, every 2 weeks until week 6, every 3 months until year 2, every 6 months until the end of treatment. Survival analysis: Every 3 months until year 2 and later until the end of treatment. ; Outcome name:Clinical evaluation using version 3.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE). Measure:Safety of the treatment . Timepoints:Before the treatment, days 15 and / or 29 and later, when they are presented during the follow-up. | — |
Countries
Argentina, Australia, Austria, Belgium, Brazil, Canada, Denmark, Finland, France, Germany, Hungary, Ireland, Israel, Italy, Korea South, Mexico, Netherlands, Norway, Philippines, Poland, Russian Federation, Singapore, South Africa, Spain, Sweden, Switzerland, Taiwan, United Kindgdom, United States
Outcome results
None listed