NCT00310895

Safety and Dose Study of GRN163L Administered to Patients With Refractory or Relapsed Solid Tumor Malignancies

A Phase I, Sequential Cohort, Dose Escalation Trial to Determine the Safety, Tolerability, and MTD of GRN163L in Patients With Refractory or Relapsed Solid Tumor Malignancies

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 85 (estimated)
• 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 of GRN163L administration in treating patients with refractory or relapsed solid tumor malignancies.

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

• Solid Tumor Malignancies

Interventions

Type	Name	Description
DRUG	Imetelstat Sodium (GRN163L)	Dose increase by 25% if tolerated infused over 2 hours

Timeline

• Start date: 2006-03-01
• Primary completion: 2013-03-01
• Completion: 2013-03-01
• First posted: 2006-04-05
• Last updated: 2015-12-24

Locations

2 sites across 1 country: United States