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

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ClinicalTrials.gov Identifier: NCT00359892
Recruitment Status : Completed
First Posted : August 3, 2006
Last Update Posted : August 6, 2012
Sponsor:
Information provided by (Responsible Party):
Teva Pharmaceutical Industries ( Gemin X )

Study Description
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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.

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.


Condition or disease Intervention/treatment Phase
Hodgkin's Lymphoma Drug: Obatoclax mesylate (GX15-070MS) Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 13 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : July 2006
Actual Primary Completion Date : September 2007
Actual Study Completion Date : November 2008

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Obatoclax Mesylate
Obatoclax Mesylate 60mg
 Drug: Obatoclax mesylate (GX15-070MS)
60 mg q2wks


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00359892


Locations
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United States, Texas
MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
Gemin X
Investigators
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Study Director: Jean Viallet, MD Gemin X, Inc.
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Gemin X
ClinicalTrials.gov Identifier: NCT00359892    
Other Study ID Numbers: GEM011
First Posted: August 3, 2006    Key Record Dates
Last Update Posted: August 6, 2012
Last Verified: August 2012
Additional relevant MeSH terms:
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Lymphoma
Hodgkin Disease
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
 Immunoproliferative Disorders
Immune System Diseases
Obatoclax
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action