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

Lymphoma, Follicular Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00427856
• Other study ID #: GEM014
• Status: Completed
• Phase: Phase 2
• First received: January 25, 2007
• Last updated: July 20, 2016
• Start date: March 2007
• Est. completion date: July 2009

Study information

• Verified date: July 2016
• Source: Teva Pharmaceutical Industries
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7
• Est. completion date: July 2009
• Est. primary completion date: February 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Pathological confirmation of Follicular Lymphoma (FL)

• Must have advanced stage disease

• Must not have received any prior chemotherapy or immunotherapy for lymphoma, including steroids

• Must have adequate organ function

• Must have the ability to understand and willingness to sign a written informed consent form

Exclusion Criteria:

• No other agents or therapies administered with the intent to treat malignancy

• Uncontrolled, intercurrent illness

• Pregnant women and women who are breast feeding

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, Follicular

Intervention

Drug:
• Obatoclax mesylate
Obatoclax mesylate 40mg, and 60mg
• Rituximab
Rituximab

Locations

Country	Name	City	State
United States	The Cancer Center at Hackensack University Medical Center	Hackensack	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Gemin X

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response rate		12 weeks	Yes
Secondary	Time to Tumor Progression.		20 weeks	No