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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


Phase 2
18 Years
N/A
Not Enrolling
Both
Hodgkin's Lymphoma

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Trial Information

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


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.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Determine the response rate to obatoclax and characterize the safety profile; Determine the steady-state pharmacokinetic parameters and pharmacodynamic response.

Outcome Time Frame:

4 weeks to 1 year

Safety Issue:

Yes

Principal Investigator

Jean Viallet, MD

Investigator Role:

Study Director

Investigator Affiliation:

Gemin X, Inc.

Authority:

United States: Food and Drug Administration

Study ID:

GEM011

NCT ID:

NCT00359892

Start Date:

July 2006

Completion Date:

November 2008

Related Keywords:

  • Hodgkin's Lymphoma
  • Hodgkin Disease
  • Lymphoma

Name

Location

MD Anderson Cancer Center Houston, Texas  77030-4096