Unspecified Adult Solid Tumor, Protocol Specific Clinical Trial
Official title:
Phase I Study of the Combination of Irinotecan and MLN8237 in Advanced Solid Tumors With Emphasis on Colorectal Cancer
This phase I trial studies the side effects and best dose of alisertib when given together with irinotecan hydrochloride in treating patients with advanced solid tumors or colorectal cancer. Irinotecan hydrochloride and alisertib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
PRIMARY OBJECTIVES:
I. To investigate the feasibility and safety of MLN8237 (alisertib) when given in combination
with irinotecan (irinotecan hydrochloride) to patients with advanced solid tumors.
SECONDARY OBJECTIVES:
I. To determine the maximum tolerated dose (MTD) of MLN8237 when given in combination with
irinotecan to patients with advanced solid tumors and to recommend a phase II dose for the
combination.
II. To obtain preliminary evidence of efficacy for this combination. III. To compare the
pharmacokinetics of SN-38 (the active metabolite of irinotecan) with and without concurrent
administration of MLN8237 in an expanded cohort of patients with advanced colorectal cancer.
OUTLINE: This is a dose-escalation study of alisertib.
Patients receive irinotecan hydrochloride intravenously (IV) over 30 minutes on days 1 and 8
and alisertib orally (PO) twice daily (BID) on days 1-3 and 8-10. Courses repeat every 21
days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up for 30 days.
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