EUCTR2004-002515-89-SEActive, not recruitingNot Applicable
A Phase II Study of BMS-354825 in Subjects with Accelerated Phase Chronic MyeloidLeukemia Resistant to or Intolerant of Imatinib MesylateRevised Protocol 01: Incorporates Amendment 03 and Administrative Letter dated 01-March-2005.Amendment 01 country specific version 1.0 dated 2005-03-14
Bristol Myers Squibb International Corporation0 sites256 target enrollmentStarted: November 8, 2004Last updated:
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Enrollment
- 256
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •1) Subjects with Ph+ (or BCR/ABL+) accelerated phase chronic myeloid leukemia whose disease has primary or acquired hematologic resistance to imatinib mesylate or who are intolerant of imatinib mesylate.
- •Subjects are considered to have accelerated phase CML if they meet at least one of
- •the following criteria:
- •At least 15% to < 30% blasts in peripheral blood or 15% to < 30% blasts in bone
- •The sum of the percent blasts plus percent promyelocytes in peripheral blood or in
- •the bone marrow is = 30% (but the percent blasts alone is < 30%) and in bone
- •= 20% basophils in peripheral blood or in bone marrow
- •Platelets < 100,000/mm3 unrelated to drug therapy
- •2) ECOG performance status score 0 - 2 (See Appendix 1)
- •3) Adequate hepatic function defined as:
- •total bilirubin = 2.0 times the institutional upper limit of normal
- •alanine aminotransferase (ALT) and aspartate aminotransferase (AST) = 2.5 times the institutional upper limit of normal
- •4) Adequate renal function defined as:
- •serum creatinine = 1.5 times the institutional upper normal limit
- •5) Serum potassium and magnesium levels within institutional normal limits. Total serum calcium or ionized calcium level must be greater than or equal to the lower
- •limit of normal.
- •6) Men and women, 18 years of age or older.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
Exclusion Criteria
- •1) Women who are pregnant or breastfeeding.
- •2) WOCBP who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period of at least 1 month before and for at least 3 months after completion of the study medication.
- •3) Subjects who are eligible and willing to undergo transplantation during the screening period.
- •4) A serious uncontrolled medical disorder or active infection that would impair the ability of the subject to receive protocol therapy.
- •5) Uncontrolled or significant cardiovascular disease
- •6) Subjects who received:
- •- imatinib mesylate within 7 days
- •- interferon or cytarabine within 14 days
- •- a targeted small molecule anti-cancer agent within 14 days,
- •- any other investigational or antineoplastic agent other than hydroxyurea within 28 days before starting treatment with BMS-354825
- •7) Subjects currently taking drugs that are generally accepted to have a risk of causing Torsades de Pointes
- •8) Subjects taking medications that irreversibly inhibit platelet function
- •9) Prior therapy with BMS-354825.
Investigators
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