NCT00514696

Study of the Safety of GCS-100 in Subjects With Chronic Lymphocytic Leukemia

Open Label Phase 2 Study of the Safety and Biological Activity of GCS-100 in Subjects With Chronic Lymphocytic Leukemia

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: La Jolla Pharmaceutical Company · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the safety of GCS-100 and the biologic activity of GCS-100 in subjects with chronic lymphocytic leukemia.

Detailed description

The primary objective of this study is to evaluate the safety of GCS-100, and effect of GCS-100 on markers of apoptosis in subjects with chronic lymphocytic leukemia. The secondary objective of this study is to evaluate the effect of GCS-100 on peripheral blood leukocyte count in subjects with chronic lymphocytic leukemia.

Conditions

• Chronic Lymphocytic Leukemia

Interventions

Type	Name	Description
DRUG	GCS-100	GCS-100: 160 mg/m2 IV (in the vein) Study Days 1-5 of each 21-day cycle

Timeline

• Start date: 2007-02-01
• Primary completion: 2009-04-01
• Completion: 2009-04-01
• First posted: 2007-08-10
• Last updated: 2013-06-17

Locations

8 sites across 1 country: United States