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

Hodgkin's Lymphoma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00359892
• Other study ID #: GEM011
• Status: Completed
• Phase: Phase 2
• First received: August 2, 2006
• Last updated: August 3, 2012
• Start date: July 2006
• Est. completion date: November 2008

Study information

• Verified date: August 2012
• Source: Teva Pharmaceutical Industries
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationCanada: Health Canada
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: November 2008
• Est. primary completion date: September 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hodgkin Disease
• Hodgkin's Lymphoma
• Lymphoma

Intervention

Drug:
• Obatoclax mesylate (GX15-070MS)
60 mg q2wks

Locations

Country	Name	City	State
United States	MD Anderson Cancer Center	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Gemin X

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes