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A Phase II Study of Obatoclax Mesylate (GX15-070MS) in Patients With Previously-Untreated Myelodysplastic Syndromes (MDS) With Anemia and/or Thrombocytopenia


Phase 2
18 Years
N/A
Not Enrolling
Both
Myelodysplastic Syndromes

Thank you

Trial Information

A Phase II Study of Obatoclax Mesylate (GX15-070MS) in Patients With Previously-Untreated Myelodysplastic Syndromes (MDS) With Anemia and/or Thrombocytopenia


Inclusion Criteria:



- Pathological confirmation of Myelodysplastic Syndromes (MDS)

- Patients must have had no prior systemic therapy

- Must have normal organ functions

- Must have the ability to understand and willingness to sign a written informed
consent form

Exclusion Criteria:

- Must not be a result of prior chemotherapy and/or radiotherapy for another malignancy

- No other agents or therapies administered in the intent to treat

- Uncontrolled, intercurrent illness

- Pregnant women and women who are breast feeding

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

International Working Group (IWG) Response Criteria for MDS

Outcome Description:

Determine the response rate according to bone marrow blast count less than or equal to 10%

Outcome Time Frame:

52 weeks

Safety Issue:

No

Principal Investigator

Mark Berger, MD

Investigator Role:

Study Director

Investigator Affiliation:

Gemin X, Inc.

Authority:

United States: Food and Drug Administration

Study ID:

GEM013

NCT ID:

NCT00413114

Start Date:

December 2006

Completion Date:

November 2009

Related Keywords:

  • Myelodysplastic Syndromes
  • Myelodysplastic Syndromes
  • Preleukemia

Name

Location
Stanford University Stanford, California  94305
Arlington Cancer Center Arlington, Texas  76012
Mary Crowley Medical Research Center Dallas, Texas  75246
St. Vincent's Comprehensive Cancer Center New York, New York  10011
University of Chicago Chicago, Illinois  60637
Georgetown University Medical Center Washington, District of Columbia  20007
Hematology-Oncology Centers of the Northern Rockies Billings, Montana  59101
The West Clinic Memphis, Tennessee  38120
James A. Haley Veterans Hospital Tampa, Florida  33612
Northwest Georgia Oncology Centers Marietta, Georgia  30060
University of Massachusetts Medical Center Worcester, Massachusetts  01605
Sarah Cannon Cancer Research Institute Nashville, Tennessee  37203
Emory University School of Medicine/ Winship Cancer Center Atlanta, Georgia  30322
Michigan State University, Breslin Cancer Center CTO Lansing, Michigan  48910
Pacific Oncology Portland, Oregon  97210
Texax Oncology, P.A., Presbyterian/ Mary Crowley Clinical Research Centers Dallas, Texas  75231
MD Anderson Cancer Center (Protocol 2006-0688) Houston, Texas  77030