Safety and Efficacy of Obatoclax Mesylate (GX15-070MS) in Combination With Bortezomib for the Treatment of Relapsed or Refractory Mantle Cell Lymphoma (MCL)

NCT00407303 | Completed Phase 1

• 1 other identifier: GEM012
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 5

Brief 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.

Conditions

Mantle-Cell Lymphoma

Outcome Measures

Primary Outcomes (1)

• Determine the response rate to obatoclax in combination with Bortezomib and characterize the safety profile

  4 weeks to 2 years

Secondary Outcomes (1)

• Peripheral blood counts; Bone marrow aspirates and biopsies; Transfusion and growth factor requirements

  4 weeks to 2 years

Study Arms (3)

1

EXPERIMENTAL

30mg obatoclax, 1.0mg/m2 bortezomib

Drug: Obatoclax mesylate; Drug: Bortezomib

2

EXPERIMENTAL

obatoclax 30 mg, bortezomib 1.3 mg/m2

Drug: Obatoclax mesylate; Drug: Bortezomib

3

EXPERIMENTAL

Obatoclax 45 mg, Bortezomib 1.3 mg/m2

Drug: Obatoclax mesylate; Drug: Bortezomib

Interventions

Obatoclax mesylate DRUG

30 mg, 45 mg

Also known as: (GX15-070MS)

1; 2; 3

Bortezomib DRUG

1.0mg/m2, 1.3 mg/m2

1; 2; 3

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Pathological confirmation of Mantle Cell Lymphoma (ML)
• Must have documented relapse or progression following 1 or 2 prior lines of antineoplastic therapy
• Must have normal organ function
• Must have the ability to understand and willingness to sign a written informed consent form

You may not qualify if:

• No other agents or therapies administered with the intent to treat malignancy
• Patients with prior exposure to obatoclax
• Uncontrolled, intercurrent illness
• Pregnant women and women who are breast feeding

Sponsors & Collaborators

• Gemin X: lead

Study Sites (5)

NW Georgia Oncology Centers

Marietta, Georgia, 30060, United States

Location

Northwestern University Feinberg School of Medicine

Chicago, Illinois, 60611, United States

Location

Hackensack University Medical Center

Hackensack, New Jersey, 07601, United States

Location

Roswell Park Medical Center

Buffalo, New York, 14263, United States

Location

University of Wisconsin

Madison, Wisconsin, 53792, United States

Location

MeSH Terms

Conditions

Lymphoma, Mantle-Cell

Interventions

obatoclax; Bortezomib

Condition Hierarchy (Ancestors)

Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Boronic Acids; Acids, Noncarboxylic; Acids; Inorganic Chemicals; Boron Compounds; Organic Chemicals; Pyrazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Jean Viallet, MD

  Gemin X, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 1, 2006
• First Posted: December 5, 2006
• Study Start: October 1, 2006
• Primary Completion: March 1, 2009
• Study Completion: November 1, 2009
• Last Updated: July 21, 2016

Record last verified: 2016-07

Locations

US (5)