NCT01234038

Safety and Tolerability Study of ISIS EIF4E Rx in Combination With Carboplatin and Paclitaxel

A Phase 1b/2 Study of Carboplatin-Paclitaxel, With or Without ISIS 183750 (an eIF4E Inhibitor), in Patients With Stage IV Non-Small Cell Lung Cancer

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 116 (actual)
• Sponsor: Ionis Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to examine the overall survival of patients with Stage IV non-small cell lung cancer (NSCLC) treated with ISIS EIF4E Rx in combination with carboplatin and paclitaxel.

Conditions

• Non-small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	ISIS EIF4E Rx	800 mg ISIS EIF4E Rx administered as a 3-hour intravenous infusion on Days 1, 8 and 15 of each 21 day cycle
DRUG	ISIS EIF4E Rx	1000 mg ISIS EIF4E Rx administered as a 3-hour intravenous infusion on Days 1, 8 and 15 of each 21 day cycle
DRUG	ISIS EIF4E Rx	(Dose identified in Part 1)ISIS EIF4E Rx administered as a 3-hour intravenous infusion on Days 1, 8, and 15 of each 21 day cycle
DRUG	Paclitaxel	200 mg/m2 administered as a 3-hour intravenous infusion on Day 1 of each 21 day cycle
DRUG	Carboplatin	AUC 6.0 mg/mL/min administered as a 1-hour intravenous infusion on Day 1 of each 21 day cycle

Timeline

• Start date: 2010-11-01
• Primary completion: 2012-10-01
• Completion: 2013-01-01
• First posted: 2010-11-04
• Last updated: 2018-06-27

Locations

29 sites across 4 countries: United States, Hungary, Poland, Russia