A Phase I Trial of Riluzole and Sorafenib in Patients With Advanced Solid Tumors and Melanoma
PRIMARY OBJECTIVES:
I. To define a safe dose of sorafenib tosylate to combine with riluzole in the treatment of
patients with all types of solid tumors refractory to standard therapy or for whom no
standard therapy exists.
SECONDARY OBJECTIVES:
I. To examine the correlation of clinical or radiologic response with signaling through the
MAPK and PI3K/AKT pathways.
II. To determine whether response to therapy with riluzole and sorafenib tosylate correlates
with expression levels of BCL-2, MCL-1, or BIM.
III. To characterize the pharmacokinetics of the combination of riluzole with sorafenib
tosylate and determine if any drug-drug interactions exist.
IV. To evaluate the microvesicle (an inter-cellular communication approach which may cargo
proteins, RNAs and DNAs to its host cell) quantification difference between pre-treatment
and post-treatment peripheral blood samples of patients.
OUTLINE: This is a dose-escalation study of sorafenib tosylate followed by an
expansion-cohort study.
Patients receive riluzole orally (PO) twice daily and sorafenib tosylate PO once daily on
days 1-28. Courses repeat every 28 days in the absence of disease progression or
unacceptable toxicity.
Blood samples are collected at baseline and periodically during course 1 for pharmacokinetic
studies. Some patients undergo tumor biopsies at baseline and prior to course 2 for
correlative studies.
After completion of study therapy, patients are followed up for approximately 2-3 years.
Interventional
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Maximum-tolerated dose of sorafenib tosylate and riluzole in patients with all types of solid tumors
28 days
Yes
Janice Mehnert
Principal Investigator
Cancer Institute of New Jersey
United States: Food and Drug Administration
NCI-2011-02597
NCT01303341
February 2011
Name | Location |
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Cancer Institute of New Jersey | New Brunswick, New Jersey 08901 |