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

NCT00359892 | Completed Phase 2

• 1 other identifier: GEM011
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

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.

Conditions

Hodgkin's Lymphoma

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Obatoclax Mesylate

EXPERIMENTAL

Obatoclax Mesylate 60mg

Drug: Obatoclax mesylate (GX15-070MS)

Interventions

Obatoclax mesylate (GX15-070MS) DRUG

60 mg q2wks

Obatoclax Mesylate

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Gemin X: lead

Study Sites (1)

MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Publications (1)

• 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.

  PMID: 22383790 DERIVED

MeSH Terms

Conditions

Hodgkin Disease

Interventions

obatoclax

Condition Hierarchy (Ancestors)

Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Jean Viallet, MD

  Gemin X, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 2, 2006
• First Posted: August 3, 2006
• Study Start: July 1, 2006
• Primary Completion: September 1, 2007
• Study Completion: November 1, 2008
• Last Updated: August 6, 2012

Record last verified: 2012-08

Locations

US (1)