Adult Solid Neoplasm Clinical Trial
Official title:
A Phase 1 Study of ARQ 197 in Combination With Temsirolimus in Advanced Solid Tumors
This phase I trial studies the side effects and best dose of tivantinib when given in combination with temsirolimus in treating patients with solid tumors that have spread to other parts of the body or cannot be removed by surgery. Tivantinib and temsirolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
PRIMARY OBJECTIVES:
I. To determine the maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D) of
ARQ197 (tivantinib) in combination with temsirolimus in adult subjects with advanced solid
tumors who are extensive cytochrome P450, family 2, subfamily C, polypeptide 19 (CYP2C19)
metabolizers.
SECONDARY OBJECTIVES:
I. To characterize the tolerability and/or MTD of ARQ 197 and in combination with
temsirolimus in adult subjects who are poor CYP2C19 metabolizers (CYP2C19*2/*2, *2/*3 or
*3/*3 polymorphisms).
II. To identify the pharmacokinetic parameters of ARQ 197 after a single dose and at steady
state in extensive and poor CYP2C19 metabolizers.
III. To assess the steady state pharmacokinetics of ARQ 197 alone and in combination with
temsirolimus.
IV. To determine impact of cytochrome P450, family 3, subfamily A, polypeptide 4/cytochrome
P450, family 3, subfamily A, polypeptide 5 (CYP3A4/5) polymorphisms on ARQ 197
pharmacokinetic parameters.
V. To determine the pharmacokinetics of temsirolimus and its active metabolite sirolimus in
combination with ARQ 197 and compare to historical pharmacokinetic data.
VI. To determine impact of CYP3A4/5 polymorphisms on temsirolimus pharmacokinetic
parameters.
VII. To describe the dose-limiting toxicities and determine the safety profile of the
combination of ARQ 197 and temsirolimus.
VIII. To evaluate the preliminary anti-tumor activity of ARQ197 and temsirolimus in patients
with advanced solid tumors.
IX. To correlate archived tumor tissue expression of c-Met with objective response to ARQ
197 and temsirolimus therapy.
OUTLINE: This is a dose-escalation study of tivantinib.
Patients receive tivantinib orally (PO) twice daily (BID) and temsirolimus intravenously
(IV) over 30 minutes on days 1, 8, 15, and 22 (days 8, 15, 22, and 29 of course 1). Courses
repeat every 28 days (35 days in course 1) in the absence of disease progression or
unacceptable toxicity.
After completion of study treatment, patients are followed up for at least 4 weeks.
;
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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