A Phase II Study of BMS-354825 in Subjects with Myeloid Blast Phase Chronic MyeloidLeukemia Resistant to or Intolerant of Imatinib MesylateProtocol version 1.0 dated 2004-10-05, andAmendment 01 country specific version 1.0 dated 2005-03-14

• Conditions: Myeloid Blast Phase Chronic Myeloid Leukemia

• Registration Number: EUCTR2004-002516-28-DK
• Lead Sponsor: Bristol Myers Squibb International Corporation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-02-28
• Last Update Posted: 28 August 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 256

Inclusion Criteria

1) Subjects with Ph+ (or BCR/ABL+) myeloid blast 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 myeloid blast phase CML if they meet at least one of
the following criteria:
• = 30% myeloid blasts in peripheral blood or in bone marrow
• Extramedullary infiltrates of leukemic cells (other than in spleen or liver) with eripheral blood myeloid blast morphology
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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified