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Safety and Efficacy of Obatoclax Mesylate (GX15-070MS)for the Treatment of Myelodysplastic Syndromes (MDS)

Primary Purpose

Myelodysplastic Syndromes

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Obatoclax mesylate (GX15-070MS)
Sponsored by
Gemin X
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myelodysplastic Syndromes

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Stanford University
  • Georgetown University Medical Center
  • James A. Haley Veterans Hospital
  • Emory University School of Medicine/ Winship Cancer Center
  • Northwest Georgia Oncology Centers
  • University of Chicago
  • University of Massachusetts Medical Center
  • Michigan State University, Breslin Cancer Center CTO
  • Hematology-Oncology Centers of the Northern Rockies
  • St. Vincent's Comprehensive Cancer Center
  • Pacific Oncology
  • The West Clinic
  • Sarah Cannon Cancer Research Institute
  • Arlington Cancer Center
  • Texax Oncology, P.A., Presbyterian/ Mary Crowley Clinical Research Centers
  • Mary Crowley Medical Research Center
  • MD Anderson Cancer Center (Protocol 2006-0688)
  • Tom Baker Cancer Centre
  • QEII HSC
  • Princess Margaret Hospital
  • Hospital Notre-Dame du Chum
  • Maisonneuve-Rosemont Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Obatoclax Mesylate

Arm Description

Obatoclax Mesylate 30mg

Outcomes

Primary Outcome Measures

International Working Group (IWG) Response Criteria for MDS
Determine the response rate according to bone marrow blast count less than or equal to 10%

Secondary Outcome Measures

Peripheral blood counts; Bone marrow aspirates and biopsies; Transfusions and growth factor requirements
hemoglobin level less than 10 g/dL and or platelets less than 50 x 10 9/L. Eastern Cooperative Onocology Group (ECOG) performance status: 0 fully active-2 ambulatory 50% of the time; and total bilirubin less than or equal to 2 mg/dL; normal limits of SGOT/SGPT and creatinine according to laboratory standards

Full Information

First Posted
December 18, 2006
Last Updated
August 16, 2013
Sponsor
Gemin X
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1. Study Identification

Unique Protocol Identification Number
NCT00413114
Brief Title
Safety and Efficacy of Obatoclax Mesylate (GX15-070MS)for the Treatment of Myelodysplastic Syndromes (MDS)
Official Title
A Phase II Study of Obatoclax Mesylate (GX15-070MS) in Patients With Previously-Untreated Myelodysplastic Syndromes (MDS) With Anemia and/or Thrombocytopenia
Study Type
Interventional

2. Study Status

Record Verification Date
August 2013
Overall Recruitment Status
Completed
Study Start Date
December 2006 (undefined)
Primary Completion Date
February 2009 (Actual)
Study Completion Date
November 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Gemin X

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Defects in the apoptotic process can lead to the onset of cancer by allowing cells to grow unchecked when an oncogeneic 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 obatoclax administered in 2-week cycles to patients with previously-untreated Myelodysplastic Syndromes with anemia and/or thrombocytopenia. Treatment may be administered on an outpatient basis. No investigational or commercial agents or therapies other than those described herein may be administered with the intent to treat the patient's malignancy. Supportive care measures including those directed at controlling symptoms resulting from Myelodysplastic Syndromes are allowed

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myelodysplastic Syndromes

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Obatoclax Mesylate
Arm Type
Experimental
Arm Description
Obatoclax Mesylate 30mg
Intervention Type
Drug
Intervention Name(s)
Obatoclax mesylate (GX15-070MS)
Primary Outcome Measure Information:
Title
International Working Group (IWG) Response Criteria for MDS
Description
Determine the response rate according to bone marrow blast count less than or equal to 10%
Time Frame
52 weeks
Secondary Outcome Measure Information:
Title
Peripheral blood counts; Bone marrow aspirates and biopsies; Transfusions and growth factor requirements
Description
hemoglobin level less than 10 g/dL and or platelets less than 50 x 10 9/L. Eastern Cooperative Onocology Group (ECOG) performance status: 0 fully active-2 ambulatory 50% of the time; and total bilirubin less than or equal to 2 mg/dL; normal limits of SGOT/SGPT and creatinine according to laboratory standards
Time Frame
52 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark Berger, MD
Organizational Affiliation
Gemin X, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Stanford University
City
Stanford
State/Province
California
ZIP/Postal Code
00000
Country
United States
Facility Name
Georgetown University Medical Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20007
Country
United States
Facility Name
James A. Haley Veterans Hospital
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Facility Name
Emory University School of Medicine/ Winship Cancer Center
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Northwest Georgia Oncology Centers
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30060
Country
United States
Facility Name
University of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
University of Massachusetts Medical Center
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01605
Country
United States
Facility Name
Michigan State University, Breslin Cancer Center CTO
City
Lansing
State/Province
Michigan
ZIP/Postal Code
48910
Country
United States
Facility Name
Hematology-Oncology Centers of the Northern Rockies
City
Billings
State/Province
Montana
ZIP/Postal Code
59101
Country
United States
Facility Name
St. Vincent's Comprehensive Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
01605
Country
United States
Facility Name
Pacific Oncology
City
Portland
State/Province
Oregon
ZIP/Postal Code
97210
Country
United States
Facility Name
The West Clinic
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38120
Country
United States
Facility Name
Sarah Cannon Cancer Research Institute
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
Arlington Cancer Center
City
Arlington
State/Province
Texas
ZIP/Postal Code
76012
Country
United States
Facility Name
Texax Oncology, P.A., Presbyterian/ Mary Crowley Clinical Research Centers
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
Mary Crowley Medical Research Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
Facility Name
MD Anderson Cancer Center (Protocol 2006-0688)
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Tom Baker Cancer Centre
City
Calgary
State/Province
Alberta
Country
Canada
Facility Name
QEII HSC
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H 2Y9
Country
Canada
Facility Name
Princess Margaret Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2M9
Country
Canada
Facility Name
Hospital Notre-Dame du Chum
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2L4M1
Country
Canada
Facility Name
Maisonneuve-Rosemont Hospital
City
Montreal
State/Province
Quebec
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
25052051
Citation
Arellano ML, Borthakur G, Berger M, Luer J, Raza A. A phase II, multicenter, open-label study of obatoclax mesylate in patients with previously untreated myelodysplastic syndromes with anemia or thrombocytopenia. Clin Lymphoma Myeloma Leuk. 2014 Dec;14(6):534-9. doi: 10.1016/j.clml.2014.04.007. Epub 2014 Jun 12.
Results Reference
derived

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Safety and Efficacy of Obatoclax Mesylate (GX15-070MS)for the Treatment of Myelodysplastic Syndromes (MDS)

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