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

Sponsor

Gemin X (Industry)

Overall Status

Completed

CT.gov ID

NCT00359892

Collaborator

(none)

Enrollment

Location

Arm

28.1

Duration (Months)

0.5

Patients Per Site Per Month

Study Details

Study Description

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

Study Type:

Interventional

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 :

Jul 1, 2006

Actual Primary Completion Date :

Sep 1, 2007

Actual Study Completion Date :

Nov 1, 2008

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: Obatoclax Mesylate

Obatoclax Mesylate 60mg

Drug: Obatoclax mesylate (GX15-070MS)

60 mg q2wks

Outcome Measures

Primary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	MD Anderson Cancer Center	Houston	Texas	United States	77030

Sponsors and Collaborators

Gemin X

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Gemin X

ClinicalTrials.gov Identifier:

NCT00359892

Other Study ID Numbers:

GEM011

First Posted:

Aug 3, 2006

Last Update Posted:

Aug 6, 2012

Last Verified:

Aug 1, 2012

Additional relevant MeSH terms:

Lymphoma

Hodgkin Disease

Obatoclax

Study Results

No Results Posted as of Aug 6, 2012