NCT01138163

Study of Bavituximab Plus Docetaxel in Patients With Locally Advanced or Metastatic Non-Squamous Non Small-Cell Lung Cancer

A Randomized, Double-Blind, Placebo-Controlled Phase 2 Trial of Bavituximab Plus Docetaxel in Patients With Previously Treated Locally Advanced or Metastatic Non-Squamous Non Small-Cell Lung Cancer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 121 (actual)
• Sponsor: Peregrine Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The primary purpose of this research study is to see whether adding bavituximab (an investigational drug) to the standard chemotherapy drug docetaxel, will improve the results of the treatment for non-small-cell lung cancer.

Conditions

• Non-small-cell Lung Cancer

Interventions

Type	Name	Description
DRUG	Docetaxel plus bavituximab or placebo	Patients will be randomized to receive docetaxel plus placebo, docetaxel plus 1 mg/kg bavituximab, or docetaxel plus 3 mg/kg bavituximab in the Combination Therapy Period. The Combination Treatment Period for each patient will begin on Study Day 1. Docetaxel, 75 mg/m2, will be given on Day 1 of each 21 day cycle for up to 6 cycles, and placebo or the assigned dose of bavituximab will be given weekly. Docetaxel administration will occur every 21 days. All patients who complete the Combination Therapy Period (or discontinue for any reason other than disease progression or toxicity) will be eligible to enter the Monotherapy Period. Patients will continue to receive assigned blinded treatment (placebo or 1 or 3 mg/kg bavituximab) weekly until progression or toxicity.

Timeline

• Start date: 2010-06-01
• Primary completion: 2012-10-01
• Completion: 2013-05-01
• First posted: 2010-06-07
• Last updated: 2017-04-19

Locations

53 sites across 5 countries: United States, Georgia, India, Russia, Ukraine