A Phase II Study of BMS-354825 in Subjects With Accelerated Phase Chronic Myeloid Leukemia Resistant to or Intolerant of Imatinib Mesylate
- Conditions
- -C921 Chronic myeloid leukaemia [CML], BCR/ABL-positiveChronic myeloid leukaemia [CML], BCR/ABL-positiveC921
- Registration Number
- PER-024-05
- Lead Sponsor
- BRISTOL MYERS SQUIBB COMPANY,
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Not specified
- Target Recruitment
- 0
1) Informed consent in writen and signed.
2) Available for periodic monitoring.
3) Life expectancy of at least 3 months, approximately.
4) Score 0 - 1 in the performance status ECOG.
5) Patients with Ph + CML in chronic phase.
6) Patients must meet at least one of the following criteria: A) Has been previously treated with imatinib at a dose greater than 600 mg / day and developed progressive disease upon receiving such dose of imatinib. 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) Intolerance at any dose of imatinib.
7) Adequate liver function.
8) Adequate renal function.
9) Serum potassium and magnesium levels within the normal institutional limits.
10) Men and women 18 years of age or older
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 within 72 hours before the administration of the study drug.
5) Sexually active men whose sexual partners are MEF who may become pregnant, who are unwilling or unable to use a method of birth control that is acceptable.
6) Previous diagnosis of CML in accelerated phase or in blast crisis.
7) Patients who are eligible and willing to undergo a transplant during the selection period.
8) Severe uncontrolled medical condition or active infection that could impair the possibility of the patient receiving the protocol therapy.
9) Significant or uncontrolled cardiovascular disease.
10) Dementia or altered mental state that would prevent understanding or granting informed consent.
11) History of significant hemorrhagic disorder not associated with CML.
12) Concurrent incurable malignancy in addition to CML.
13) Evidence of organic dysfunction or digestive dysfunction that would prevent the administration of study therapy.
14) Patients who received any of the following: a) Imatinib within 7 days. b) Interferon or cytarabine within 14 days. c) A small molecule anti-cancer agent target within the previous 14 days. d) Any other antineoplastic or investigational drug, except hydroxyurea or anagrelide, within 28 days prior to the start of treatment with BMS-354825.
15) Individuals who are currently taking drugs are generally accepted that there is a risk that they cause Torsade des Pointes.
16) Individuals who are taking drugs that irreversibly inhibit platelet function.
17) Individuals taking drugs recognized as potent inhibitors or inducers of CYP3A4.
18) Previous therapy with BMS-354825.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method