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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Hodgkin's Lymphoma

Intervention / Treatment
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* Drug: Obatoclax mesylate (GX15-070MS)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

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