NCT00427856

Safety and Efficacy of Single Agent Obatoclax Mesylate (GX15-070MS) Followed by a Combination With Rituximab for Previously-untreated Follicular Lymphoma (FL)

A Multi-Center, Open-Label, Phase II Study of Sequential, Single-Agent Obatoclax Mesylate (GX15-070MS)Followed by a Combination With Rituximab to Patients With Previously-Untreated Follicular Lymphoma (FL)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 7 (actual)
• Sponsor: Gemin X · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Defects in the apoptotic process can lead to the onset of cancer by allowing cells to grow unchecked when an oncogenic signal is present. Obatoclax is designed to restore apoptosis through inhibition of the Bcl-2 family of proteins, thereby reinstating the natural process of cell death that is often inhibited in cancer cells.

Detailed description

This is a multi-center, open-label, Phase II study of obatoclax administered alone as a weekly, 3-hour or 24-hour infusion for 12 weeks followed by a combination with rituximab to patients with previously-untreated Follicular Lymphoma. For purposes of clinical evaluations, treatment cycles will occur in 4-week periods. Treatment may be administered on an outpatient basis. No investigational or commercial agents or therapies other than those described may be administered with the intent to treat the patient's malignancy.

Conditions

• Lymphoma, Follicular

Interventions

Type	Name	Description
DRUG	Obatoclax mesylate	Obatoclax mesylate 40mg, and 60mg
DRUG	Rituximab	Rituximab

Timeline

• Start date: 2007-03-01
• Primary completion: 2009-02-01
• Completion: 2009-07-01
• First posted: 2007-01-29
• Last updated: 2016-07-22

Locations

1 site across 1 country: United States