Efficacy, Safety and Pharmacokinetics Study of Antroquinonol to Treat NSCLC

Summary

This is a single arm, open label, Phase II study in KRAS-positive and KRAS-negative patients with stage IV (including pleural effusion) non squamous NSCLC who have failed two lines of anti-cancer therapy. A maximum of 60 evaluable patients with NSCLC will receive antroquinonol, of which 30 patients will be KRAS-positive and 30 patients KRAS-negative. An evaluable patient will have received at least one dose of antroquinonol and have a valid baseline tumor assessment. Enrollment will continue until the target number of evaluable patients has been enrolled.

Timeline

Start

2013-10

Primary completion

2018-12-07

Completion

2018-12-07

Drugs

Indications