Safety and Efficacy of Obatoclax Mesylate (GX15-070MS) in the Treatment of Hodgkin's Lymphoma

August 3, 2012 updated by: Gemin X

A Multi-Center, Open-Label Phase II Study of Single-Agent GX15-070MS Administered as a 24-Hour Infusion Every 2 Weeks to Patients With Relapsed or Refractory Hodgkin's Lymphoma

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.

This is a multi-center, open-label, Phase II study of single-agent obatoclax administered in 2-week cycles as a 24-hour infusion every 2 weeks at a fixed dose of 60 mg to patients with relapsed or refractory Hodgkin's Lymphoma. Infusions may be administered on an out-patient basis. No investigational or commercial agents or therapies other than those described in the protocol may be administered with the intent to treat the patient's malignancy. Supportive care measures including those directed at controlling symptoms resulting from Hodgkin's Lymphoma (blood products, growth factor, etc.) are allowed.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

13

Phase

  • Phase 2

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
    • Texas
      • Houston, Texas, United States, 77030
        • MD Anderson Cancer Center

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Pathological confirmation of Hodgkin's Lymphoma.
  • Must have measurable disease.
  • Evidence of progressive disease following at least one prior line of combination therapy.
  • Must have failed, refused, or otherwise not a candidate for stem cell transplant.
  • Patient's must have normal organ function.
  • Willing to submit to blood sampling for planned PK and PD analyses.
  • 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.
  • Prior allogeneic stem cell transplant if evidence of graft versus host disease, or requirement for steroids or other immunosuppressive therapy.
  • 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: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Obatoclax Mesylate
Obatoclax Mesylate 60mg
Drug: Obatoclax mesylate (GX15-070MS)
60 mg q2wks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Determine the response rate to obatoclax and characterize the safety profile; Determine the steady-state pharmacokinetic parameters and pharmacodynamic response.
Time Frame: 4 weeks to 1 year
4 weeks to 1 year

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.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

July 1, 2006

Primary Completion (Actual)

September 1, 2007

Study Completion (Actual)

November 1, 2008

Study Registration Dates

First Submitted

August 2, 2006

First Submitted That Met QC Criteria

August 2, 2006

First Posted (Estimate)

August 3, 2006

Study Record Updates

Last Update Posted (Estimate)

August 6, 2012

Last Update Submitted That Met QC Criteria

August 3, 2012

Last Verified

August 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GEM011

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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