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

NCT ID: NCT00359892

Last Updated: 2012-08-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

13 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-07-31

Study Completion Date

2008-11-30

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.

Detailed Description

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Conditions

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Hodgkin's Lymphoma

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Obatoclax Mesylate

Obatoclax Mesylate 60mg

Group Type EXPERIMENTAL

Obatoclax mesylate (GX15-070MS)

Intervention Type DRUG

60 mg q2wks

Interventions

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Obatoclax mesylate (GX15-070MS)

60 mg q2wks

Intervention Type DRUG

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Gemin X

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jean Viallet, MD

Role: STUDY_DIRECTOR

Gemin X, Inc.

Locations

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MD Anderson Cancer Center

Houston, Texas, United States

Site Status

Countries

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United States

References

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Oki Y, Copeland A, Hagemeister F, Fayad LE, Fanale M, Romaguera J, Younes A. Experience with obatoclax mesylate (GX15-070), a small molecule pan-Bcl-2 family antagonist in patients with relapsed or refractory classical Hodgkin lymphoma. Blood. 2012 Mar 1;119(9):2171-2. doi: 10.1182/blood-2011-11-391037. No abstract available.

Reference Type DERIVED
PMID: 22383790 (View on PubMed)

Other Identifiers

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GEM011

Identifier Type: -

Identifier Source: org_study_id