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

July 19, 2016 updated by: Gemin X

A Phase I/II Study of Obatoclax Mesylate (GX15-070MS) Administered in Combination With Bortezomib to Patients With Relapsed or Refractory Mantle Cell Lymphoma (MCL)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is a multi-center, open-label, Phase I study of Obatoclax administered in combination with bortezomib in 3-week cycles to patients with relapsed or refractory Mantle Cell Lymphoma. Treatment may be administered on an outpatient basis. No investigational or commercial agents or therapies other than those described herein may be administered with the intent to treat the patients's malignancy. Supportive care measures including those directed at controlling symptoms resulting from Mantle Cell Lymphoma are allowed.

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Georgia
      • Marietta, Georgia, United States, 30060
        • NW Georgia Oncology Centers
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Northwestern University Feinberg School of Medicine
    • New Jersey
      • Hackensack, New Jersey, United States, 07601
        • Hackensack University Medical Center
    • New York
      • Buffalo, New York, United States, 14263
        • Roswell Park Medical Center
    • Wisconsin
      • Madison, Wisconsin, United States, 53792
        • University of Wisconsin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
30mg obatoclax, 1.0mg/m2 bortezomib
Drug: Obatoclax mesylate
30 mg, 45 mg
Other Names:
  • (GX15-070MS)
Drug: Bortezomib
1.0mg/m2, 1.3 mg/m2
Experimental: 2
obatoclax 30 mg, bortezomib 1.3 mg/m2
Drug: Obatoclax mesylate
30 mg, 45 mg
Other Names:
  • (GX15-070MS)
Drug: Bortezomib
1.0mg/m2, 1.3 mg/m2
Experimental: 3
Obatoclax 45 mg, Bortezomib 1.3 mg/m2
Drug: Obatoclax mesylate
30 mg, 45 mg
Other Names:
  • (GX15-070MS)
Drug: Bortezomib
1.0mg/m2, 1.3 mg/m2

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Determine the response rate to obatoclax in combination with Bortezomib and characterize the safety profile
Time Frame: 4 weeks to 2 years
4 weeks to 2 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Peripheral blood counts; Bone marrow aspirates and biopsies; Transfusion and growth factor requirements
Time Frame: 4 weeks to 2 years
4 weeks to 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gemin X

Investigators

  • Study Director: Jean Viallet, MD, Gemin X, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2006

Primary Completion (Actual)

March 1, 2009

Study Completion (Actual)

November 1, 2009

Study Registration Dates

First Submitted

December 1, 2006

First Submitted That Met QC Criteria

December 4, 2006

First Posted (Estimate)

December 5, 2006

Study Record Updates

Last Update Posted (Estimate)

July 21, 2016

Last Update Submitted That Met QC Criteria

July 19, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GEM012

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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