NCT00510445

Study of GRN163L With Paclitaxel and Carboplatin in Patients With Advanced or Metastatic Non Small Cell Lung Cancer

A Phase I Study of GRN163L in Combination With Paclitaxel and Carboplatin in Patients With Advanced or Metastatic Non-Small Cell Lung Cancer

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 27 (actual)
• Sponsor: Geron Corporation · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine the safety and the maximum tolerated dose (MTD) of GRN163L when administered in combination with a standard paclitaxel/carboplatin regimen to patients with advanced or metastatic non-small cell lung cancer.

Detailed description

GRN163L is a telomerase template antagonist with in vitro and in vivo activity in a variety of tumor model systems. Telomerase is an enzyme that is active primarily in tumor cells and is crucial for the indefinite growth of tumor cells. Inhibition of telomerase may result in antineoplastic effects.

Conditions

• Lung Cancer

Interventions

Type	Name	Description
DRUG	Imetelstat Sodium (GRN163L)	The starting dose of GRN163L for this study will be 3.2 mg/kg. Subsequent dose levels will be 4.8, 6, 7.5, 9, 11, and 13.5 mg/kg. The maximum dose to be administered will not exceed 13.5 mg/kg. Paclitaxel and carboplatin will be administered on Day 2 of each 21-day cycle.

Timeline

• Start date: 2007-07-01
• Primary completion: 2011-04-01
• Completion: 2011-04-01
• First posted: 2007-08-02
• Last updated: 2015-12-24

Locations

4 sites across 1 country: United States