BMS-354825 in Treating Patients With Chronic Phase Chronic Myelogenous Leukemia That Is Resistant to Imatinib Mesylate
- Conditions
- Leukemia
- Registration Number
- NCT00064233
- Lead Sponsor
- Jonsson Comprehensive Cancer Center
- Brief Summary
RATIONALE: BMS-354825 may stop the growth of cancer cells by stopping the enzymes necessary for cancer cell growth.
PURPOSE: This phase I trial is studying the side effects and best dose of BMS-354825 in treating patients with chronic phase chronic myelogenous leukemia that is resistant to imatinib mesylate.
- Detailed Description
OBJECTIVES:
* Determine the maximum tolerated dose, maximum administered dose, dose-limiting toxicity, and a recommended phase II dose of BMS-354825 in patients with chronic phase chronic myelogenous leukemia who have hematologic resistance to imatinib mesylate.
* Determine the safety and tolerability of this drug in these patients.
* Determine the plasma pharmacokinetics of this drug in these patients.
* Determine, preliminarily, the efficacy of this drug, in terms of hematologic, cytogenetic, and molecular responses in these patients.
OUTLINE: This is an open-label, dose-escalation, multicenter study.
Patients receive oral BMS-354825 once daily on days 1-5. Courses repeat every 7 days for at least 3 months in the absence of disease progression or unacceptable toxicity. Patients may receive further treatment in the absence of disease progression.
Cohorts of 3-6 patients receive escalating doses of BMS-354825 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity.
Once the MTD is determined, 20 additional patients receive treatment as in phase I at the MTD of BMS-354825.
Patients are followed for at least 30 days.
PROJECTED ACCRUAL: Approximately 50 patients (30 for phase I and 20 for phase II) will be accrued for this study within 12-18 months.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 42
Not provided
- extramedullary involvement (other than liver or spleen)
- significant bleeding disorder unrelated to CML
- acquired bleeding disorder within the past year (e.g., acquired antifactor VIII antibodies)
- congenital bleeding disorders (e.g., von Willebrand disease)
- uncontrolled or significant cardiovascular disease
- uncontrolled angina within the past 6 months
- congestive heart failure within the past 6 months
- myocardial infarction within the past 12 months
- history of clinically significant ventricular arrhythmias (e.g., ventricular tachycardia, ventricular fibrillation, or torsades de pointes)
- history of second or third degree heart block (may be eligible if patient has a pacemaker)
- diagnosed or suspected congenital long QT syndrome
- prolonged QTc interval on pre-entry EKG (i.e., greater than 450 msec)
- heart rate less than 50/minute on pre-entry EKG
- uncontrolled hypertension
- vasculitis
- pregnant or nursing
- gastrointestinal tract bleeding within the past 6 months
- connective tissue disorders
- other serious uncontrolled medical disorder or active infection that would impair the ability to receive study therapy
- dementia or altered mental status that would preclude giving informed consent
- evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, EKG, or clinical laboratory determinations unrelated to CML
- prisoners or patients who are compulsorily detained (e.g., involuntary incarceration for treatment of either a psychiatric or physical [e.g., infectious disease] illness)
- concurrent drugs accepted to have a risk of causing torsades de pointes
- other concurrent treatment for CML
- concurrent dolasetron or droperidol
- concurrent anticoagulants
- concurrent medications that inhibit platelet function
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Jonsson Comprehensive Cancer Center at UCLA
🇺🇸Los Angeles, California, United States