Unspecified Adult Solid Tumor, Protocol Specific Clinical Trial
Official title:
A Phase I Study of Sorafenib in Combination With the Histone Deacetylase Inhibitor, Entinostat in Patients With Advanced Cancers
This phase I trial is studying the side effects and the best dose of entinostat when given together with sorafenib tosylate in treating patients with advanced or metastatic solid tumors or refractory or relapsed acute myeloid leukemia. Entinostat and sorafenib tosylate may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.
PRIMARY OBJECTIVES:
I. To determine the maximum-tolerated dose of entinostat in combination with sorafenib
tosylate in patients with advanced, inoperable, or metastatic solid tumors.
II. To determine the safety and tolerability of this regimen in these patients.
SECONDARY OBJECTIVES:
I. To determine the pharmacokinetic profile of this regimen in patients with
refractory/relapsed acute myeloid leukemia (AML).
II. To assess the preliminary anti-tumor activity of this regimen in patients with advanced,
inoperable, or metastatic solid tumors or refractory/relapsed AML.
III. To evaluate histone deacetylase (HDAC) inhibition of histone acetylation in leukemia
blast cells.
TERTIARY OBJECTIVES (EXPLORATORY):
I. To evaluate the expression of downstream markers of drug activity such as p38, MCL-1,
FLT-3, and VEGFR-2 in leukemia blast cells.
II. To evaluate SNDX-induced expression of p21^WAF1/CIP1 in leukemia blast cells.
OUTLINE: This is a multicenter, dose-escalation study of entinostat.
Patients receive oral entinostat once daily on days 1 and 15 and oral sorafenib tosylate
twice daily on days 1-28 (days 15-28 only of course 1). Courses repeat every 28 days in the
absence of disease progression or unacceptable toxicity.
Patients in the expansion cohort undergo blood, bone marrow aspiration, or biopsy for
pharmacokinetic studies and biomarker analysis.
After completion of study therapy, patients are followed up for up to 24 months.
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Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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