Phase I Dose-Escalation Study of Ramucirumab in Chinese Patients with Advanced Solid Tumors.

ABSTRACT:

Lessons learned

Ramucirumab was well tolerated in Chinese patients with advanced solid tumors, and adverse events were manageable in this study.Pharmacokinetics characteristics in Chinese patients were similar to those in other populations. Immunogenicity was not detected.No efficacy conclusion could be drawn, and further randomized studies are warranted.

Background

This single-arm, nonrandomized, open-label, dose-escalation, phase I study was designed to evaluate the safety, tolerability, and pharmacokinetics (PK) of ramucirumab in Chinese patients with advanced solid tumors that were resistant to standard therapy or no standard therapy was available.

Methods

Dose escalation was a 3 + 3 design, with expansion in Cohorts 2 and 3 for PK. Ramucirumab was given intraveno

SUBMITTER: Cao J 

PROVIDER: S-EPMC5469595 | biostudies-literature | 2017 Jun

REPOSITORIES: biostudies-literature