A Phase II Study to Determine the Activity of BMS-354825 in Subjects with ChronicPhase Philadelphia Chromosome-Positive Chronic Myeloid Leukemia Who HaveDisease that is Resistant to High Dose Imatinib Mesylate (Gleevec) or Who areIntolerant of Imatinib
- Conditions
- Chronic phase Philadelphia chromosome-positive chronic myeloid leukemia
- Registration Number
- EUCTR2004-002601-69-ES
- Lead Sponsor
- Bristol Myers Squibb International Corporation
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 250
1) Available for periodic follow-up
2) Life expectancy of at least approximately 3 months
3) ECOG performance status score 0-1
4) Subjects with chronic phase Ph+ CML, defined as a myeloproliferative disorder with evidence of a Philadelphia chromosome on cytogenetic analysis. Subjects meeting all of the following criteria will be classified as having chronic phase CML:
• < 15% blasts in peripheral blood and in bone marrow
• < 20% basophils in peripheral blood
• < 30% blasts + promyelocytes in peripheral blood and in bone marrow
• Platelets = 100,000/mm3 unless thrombocytopenia is due to recent therapy
• No extramedullary involvement (other than liver or spleen)
5) Subjects must fulfill at least one of the following criteria relating to prior treatment
with imatinib:
A. Previously been treated with imatinib at a dose of > 600 mg/day AND developed
progressive disease while receiving imatinib at that dose.
B. CML with resistance to imatinib =600 mg/d with genetic mutation in the BCR-ABL
gene that is associated with a high level of resistance to imatinib.
C. Intolerant of imatinib at any dose.
6) 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
7) Adequate renal function defined as:
• serum creatinine = 1.5 times the institutional upper normal limit
8) 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.
9) Men and women, ages 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
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 at least 3 months
after completion of the study medication.
3) Previous diagnosis of accelerated phase or blast crisis CML
4) Subjects who are eligible and willing to undergo transplantation during the screening period
5) A serious uncontrolled medical disorder or active infection that would impair the
ability of the subject to receive protocol therapy.
6) Uncontrolled or significant cardiovascular disease
7) History of significant bleeding disorder unrelated to CML,
8) Concurrent incurable malignancy other than CML.
9) Evidence of organ dysfunction or digestive dysfunction that would prevent
administration of study therapy
10) Subjects who received
a) imatinib within 7 days
b) interferon or cytarabine within 14 days
c) a targeted small molecule anti-cancer agent within 14 days,
d) any other investigational or antineoplastic agent other than hydroxyurea or
anagrelide within 4 weeks before starting treatment with BMS-354825
11) Subjects currently taking drugs that are generally accepted to have a risk of causing Torsade de Pointes.
12) Subjects taking medications that irreversibly inhibit platelet function
13) Subjects taking medications known to be potent CYP3A4 inhibitors or inducers
14) Prior therapy with BMS-354825.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method