Recurrent Adult Acute Myeloid Leukemia Clinical Trial
Official title:
Phase I Dose Escalation Trial of the Raf Kinase Inhibitor BAY 43-9006 (NSC #724772) as Single Agent for Adults With Relapsed and Refractory Acute Leukemias and Chronic Myeloid Leukemia in Blast Crisis
This phase I trial is studying the side effects and best dose of sorafenib in treating patients with relapsed or refractory acute myeloid leukemia, acute lymphoblastic leukemia, or chronic myelogenous leukemia. Sorafenib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the cancer
PRIMARY OBJECTIVES:
I. To determine the dose-limiting toxicity(s) (DLTs) and maximally tolerated dose (MTD) of
BAY 43-9006 given orally.
SECONDARY OBJECTIVES:
I. To obtain preliminary evidence of tumor response to BAY 43-9006 in patients. II. To
assess the pharmacokinetic profile of BAY 43-9006. III. To characterize the preliminary
profile of adverse events and changes in laboratory parameters in patients treated with BAY
43-9006.
IV. To assess effects of BAY 43-9006 on various cellular properties of leukemic blasts
exposed to drug in vivo and in vitro.
OUTLINE: This is an open-label, dose-escalation study.
Patients receive oral sorafenib twice daily on days 1-14 or 1-21. Treatment repeats every 28
days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Patients achieving a complete remission (CR) may be considered for retreatment with
sorafenib for up to an additional 6 courses upon disease recurrence provided the duration of
CR is longer than 1 month.
Cohorts of 3-6 patients receive escalating doses of sorafenib until the maximum tolerated
dose (MTD) is determined. The MTD is defined as the dose preceding that which 2 of 3 or 2 of
6 patients experience dose-limiting toxicity. A total of 12 patients are treated at the MTD.
After completion of study treatment, patients are followed monthly for up to 1 year.
;
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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