A phase I study of indoximod in patients with advanced malignancies.

ABSTRACT:

Purpose

Indoximod is an oral inhibitor of the indoleamine 2,3-dioxygenase pathway, which causes tumor-mediated immunosuppression. Primary endpoints were maximum tolerated dose (MTD) and toxicity for indoximod in patients with advanced solid tumors. Secondary endpoints included response rates, pharmacokinetics, and immune correlates.

Experimental design

Our 3+3 phase I trial comprised 10 dose levels (200, 300, 400, 600, and 800 mg once/day; 600, 800, 1200, 1600, and 2000 mg twice/day). Inclusion criteria were measurable metastatic solid malignancy, age ≥18 years, and adequate organ/marrow function. Exclusion criteria were chemotherapy ≤ 3 weeks prior, untreated brain metastases, autoimmune disease, or malabsorption.

Results

In 48 patients, MTD was not reached at 2000 m

SUBMITTER: Soliman HH 

PROVIDER: S-EPMC5008412 | biostudies-literature | 2016 Apr

REPOSITORIES: biostudies-literature