drugset / Trial / NCT02826161

A Study of Napabucasin (BBI-608) Plus Weekly Paclitaxel Versus Weekly Paclitaxel Alone in Patients With Advanced, Previously Treated, Non-Squamous Non-Small Cell Lung Cancer

NCT02826161

Phase 3 Terminated 4 enrolled Sumitomo Pharma America, Inc.
RandomizedParallel-groupOpen-labelTreatment

Summary

This is an international, multi-center, prospective, randomized, open-label Phase 3 clinical trial of the cancer stemness inhibitor napabucasin administered with weekly paclitaxel versus weekly paclitaxel alone in patients with advanced non-squamous non-small cell lung cancer who have disease progression following systemic treatment with a platinum-based combination regimen in the metastatic setting, who have received treatment with an immune checkpoint inhibitor if a candidate, additional approved therapies, and for whom weekly paclitaxel is an acceptable treatment option.

Timeline

Start
2016-11
Primary completion
2017-04-24
Completion
2017-04-24

Drugs

EvaluationDrugModalityDoseRoute
Subject Napabucasin Small molecule 240 mg Oral
Subject Paclitaxel Small molecule 80 mg/m2 Intravenous