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

• ClinicalTrials.gov Identifier: NCT00359892
• Recruitment Status: Completed
• First Posted: August 3, 2006
• Last Update Posted: August 6, 2012
• Sponsor: Gemin X
• Information provided by (Responsible Party): Teva Pharmaceutical Industries ( Gemin X )

Tracking Information

• First Submitted Date: August 2, 2006
• First Posted Date: August 3, 2006
• Last Update Posted Date: August 6, 2012
• Study Start Date: July 2006
• Actual Primary Completion Date: September 2007 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: January 3, 2008): Determine the response rate to obatoclax and characterize the safety profile; Determine the steady-state pharmacokinetic parameters and pharmacodynamic response. [ Time Frame: 4 weeks to 1 year ]
• Original Primary Outcome Measures (submitted: August 2, 2006): Determine the response rate to obatoclax and characterize the safety profile; Determine the steady-state pharmacokinetic parameters and pharmacodynamic response.
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

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

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.

• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: Non-Randomized; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Hodgkin's Lymphoma

Intervention

Drug: Obatoclax mesylate (GX15-070MS)

60 mg q2wks

Study Arms

Experimental: Obatoclax Mesylate

Obatoclax Mesylate 60mg

Intervention: Drug: Obatoclax mesylate (GX15-070MS)

• Publications *: 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: September 13, 2010): 13
• Original Enrollment (submitted: August 2, 2006): 29
• Actual Study Completion Date: November 2008
• Actual Primary Completion Date: September 2007 (Final data collection date for primary outcome measure)

Eligibility Criteria

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT00359892
• Other Study ID Numbers: GEM011
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Teva Pharmaceutical Industries ( Gemin X )
• Study Sponsor: Gemin X
• Collaborators: Not Provided

Investigators

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

• PRS Account: Teva Pharmaceutical Industries
• Verification Date: August 2012