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A Phase 1 study evaluating AMG 337 in Asian patients with advanced solid tumors.

Abstract：

:AMG 337, a selective small-molecule MET inhibitor, was evaluated in Asian patients with advanced solid tumors. Eligible patients orally self-administered AMG 337; the initial dose of 150 mg once daily (QD) was escalated to 300 mg QD (modified 3+3+3 design). Treatment continued until disease progression, intolerability, or death. The primary endpoint was adverse events (AEs) and clinical abnormalities defined as dose-limiting toxicities (DLTs). Secondary endpoints included other AEs, pharmacokinetics and tumor response. Eleven patients were enrolled. No DLTs occurred. The most common treatment-emergent AEs were headache (73%) and nausea (45%). Cmax and AUC0-24 exposures increased proportionally with dose; t1/2 was comparable between groups; plasma accumulation was minimal over 28 days. One patient (150 mg) had partial response; one patient (300 mg) had stable disease. Safety, tolerability, pharmacokinetics and efficacy of AMG 337 in Asian patients were consistent with those observed in Western patient populations. The study was terminated early.

journal_name

Jpn J Clin Oncol

journal_title

Japanese journal of clinical oncology

authors

Yasui H,Go N,Yang H,Amore BM,Jung AS,Doi T

doi

10.1093/jjco/hyx067

subject

Has Abstract

pub_date

2017-08-01 00:00:00

pages

772-776

issue

8

eissn

0368-2811

issn

1465-3621

pii

3861340

journal_volume

47

pub_type

杂志文章

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