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

Sponsor
Gemin X (Industry)
Overall Status
Completed
CT.gov ID
NCT00413114
Collaborator
(none)
24
Enrollment
22
Locations
1
Arm
35
Duration (Months)
1.1
Patients Per Site
0
Patients Per Site Per Month

Study Details

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

Condition or Disease Intervention/Treatment Phase
  • Drug: Obatoclax mesylate (GX15-070MS)
 Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
24 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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 Start Date :
Dec 1, 2006
Actual Primary Completion Date :
Feb 1, 2009
Actual Study Completion Date :
Nov 1, 2009

Arms and Interventions

Arm Intervention/Treatment
Experimental: Obatoclax Mesylate

Obatoclax Mesylate 30mg

Drug: Obatoclax mesylate (GX15-070MS)

Outcome Measures

Primary Outcome Measures

  1. International Working Group (IWG) Response Criteria for MDS [52 weeks]

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

Secondary Outcome Measures

  1. Peripheral blood counts; Bone marrow aspirates and biopsies; Transfusions and growth factor requirements [52 weeks]

    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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Stanford University Stanford California United States 00000
2 Georgetown University Medical Center Washington District of Columbia United States 20007
3 James A. Haley Veterans Hospital Tampa Florida United States 33612
4 Emory University School of Medicine/ Winship Cancer Center Atlanta Georgia United States 30322
5 Northwest Georgia Oncology Centers Marietta Georgia United States 30060
6 University of Chicago Chicago Illinois United States 60637
7 University of Massachusetts Medical Center Worcester Massachusetts United States 01605
8 Michigan State University, Breslin Cancer Center CTO Lansing Michigan United States 48910
9 Hematology-Oncology Centers of the Northern Rockies Billings Montana United States 59101
10 St. Vincent's Comprehensive Cancer Center New York New York United States 01605
11 Pacific Oncology Portland Oregon United States 97210
12 The West Clinic Memphis Tennessee United States 38120
13 Sarah Cannon Cancer Research Institute Nashville Tennessee United States 37203
14 Arlington Cancer Center Arlington Texas United States 76012
15 Texax Oncology, P.A., Presbyterian/ Mary Crowley Clinical Research Centers Dallas Texas United States 75231
16 Mary Crowley Medical Research Center Dallas Texas United States 75246
17 MD Anderson Cancer Center (Protocol 2006-0688) Houston Texas United States 77030
18 Tom Baker Cancer Centre Calgary Alberta Canada
19 QEII HSC Halifax Nova Scotia Canada B3H 2Y9
20 Princess Margaret Hospital Toronto Ontario Canada M5G 2M9
21 Hospital Notre-Dame du Chum Montreal Quebec Canada H2L4M1
22 Maisonneuve-Rosemont Hospital Montreal Quebec Canada

Sponsors and Collaborators

  • Gemin X

Investigators

  • Study Director: Mark Berger, MD, Gemin X, Inc.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Gemin X
ClinicalTrials.gov Identifier:
NCT00413114
Other Study ID Numbers:
  • GEM013
First Posted:
Dec 19, 2006
Last Update Posted:
Aug 26, 2013
Last Verified:
Aug 1, 2013
Additional relevant MeSH terms:
Preleukemia
Myelodysplastic Syndromes
Syndrome
Obatoclax

Study Results

No Results Posted as of Aug 26, 2013