Phase 1 study of trebananib (AMG 386), an angiogenesis targeting angiopoietin-1/2 antagonist, in Japanese patients with advanced solid tumors.

ABSTRACT:

Purpose

To evaluate the safety, tolerability, pharmacokinetics, and antitumor activity of trebananib (AMG 386)--a first-in-class angiopoietin-1/2 antagonist peptide-Fc fusion protein--in Japanese patients, we conducted a phase 1, dose escalation study.

Methods

Eligible patients were men or women, aged between 20 and 74 years, who had histologically or cytologically confirmed advanced solid tumors refractory to standard treatment. Trebananib (3, 10, and 30 mg/kg) was administered intravenously over 60 min in weekly cycles.

Results

From June 2009 to April 2010, a total of 18 patients (6 for each dose cohort) were enrolled into the study. Trebananib was tolerated at all dose levels. No dose-limiting toxicities were observed. The most common adverse events were peripheral

SUBMITTER: Doi T 

PROVIDER: S-EPMC3535401 | biostudies-literature | 2013 Jan

REPOSITORIES: biostudies-literature