A Phase 2 Study of Dasatinib (BMS-354825) in Subjects with Accelerated Phase Chronic Myeloid Leukemia Resistant to or Intolerant of Imatinib Mesylate

Not Applicable

• Conditions: -C929 Myeloid leukaemia, unspecified; Myeloid leukaemia, unspecified; C929

• Registration Number: PER-014-05
• Lead Sponsor: BRISTOL MYERS SQUIBB COMPANY,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2005-04-28
• Last Update Posted: 4 September 2023

Recruitment & Eligibility

• Status: Complete
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1) Patients must provide written informed consent.
2) Subjects with accelerated phase chromic leukemia, which are Ph + chromosome (or BGR / ABL +), whose disease has primary or acquired haematological resistance to the imatinib mesylate. or are intolerant to Imatinib mesylate.
3) Available for scheduled follow-up
4) Score of 0 - 2 in the performance status ECOG
5) Adequate liver function.
6) Adequate renal function.
7) Serum levels of potassium and magnesium within normal limits.
8) Men and women 18 years of age or older

Exclusion Criteria

1) MEF that are not willing or able to use a method of birth control.
2) MEF who are using a prohibited contraceptive method.
3) MEF who are pregnant or breast-feeding
4) Women who have obtained a positive result in the pregnancy test performed.
5) Sexually active men whose sexual partners may become pregnant, unwilling or unable to use a method of birth control that is acceptable
6) Subjects that are eligible and willing to undergo a transplant during the selection period
7) Severe uncontrolled medical condition or active infection that could impair the possibility of the subject receiving the protocol therapy;
8) Significant or uncontrolled cardiovascular disease
9) Dementia or mental state altered.
10) History of significant hemorrhagic disorder not associated with CML
11) Concurrent incurable neoplasia different from CML.
12) Evidence of organic dysfunction or dysfunction dlgestiva.
13) Subjects who received any of the following: a) Imatinib mesylate in the previous 7 days b) Interferon or cytarabine in the previous 14 days c) An antineoplastic molecule within the previous 14 days d) Any other antineoplastic or investigational drug within the previous 28 days.
14) Individuals currently taking: Quinidine, procainamide, disopyramide, Amiodarone, sotalol, ibutilide, dofetilide, erythromlcins, clarithromycin, chlorpromazine, haloperidol, mesoridazine, thioridazine, pimozide, cizapride, bepridil, droperidol, methadone, arsenic, c-orochin , domperidone, halofantrine, levomethadyl, panetamidine, sparfloxacin, lidoflazine.
15) Individuals who are taking medications that
irreversibly inhibit platelet function.
16) Previous therapy with BMS-354825
17) Prisoners or patients, who have been detained, may not be enrolled in this study.
against your will

Study & Design

• Study Type: Interventional
• Study Design: Not specified