Clinical trial NCT00413114: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Myelodysplastic Syndromes
Lead sponsor: Teva Branded Pharmaceutical Products R&D, Inc.
Sponsor class: INDUSTRY
First posted: 2006-12-19
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


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

Primary outcomes:
measure: International Working Group (IWG) Response Criteria for MDS
timeFrame: 52 weeks
Secondary outcomes:
measure: Peripheral blood counts; Bone marrow aspirates and biopsies; Transfusions and growth factor requirements
timeFrame: 52 weeks
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University
state: California
city: Washington
country: United States
facility: Georgetown University Medical Center
state: District of Columbia
city: Tampa
country: United States
facility: James A. Haley Veterans Hospital
state: Florida
city: Atlanta
country: United States
facility: Emory University School of Medicine/ Winship Cancer Center
state: Georgia
city: Marietta
country: United States
facility: Northwest Georgia Oncology Centers
state: Georgia
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
city: Worcester
country: United States
facility: University of Massachusetts Medical Center
state: Massachusetts
city: Lansing
country: United States
facility: Michigan State University, Breslin Cancer Center CTO
state: Michigan
city: Billings
country: United States
facility: Hematology-Oncology Centers of the Northern Rockies
state: Montana
city: New York
country: United States
facility: St. Vincent's Comprehensive Cancer Center
state: New York
city: Portland
country: United States
facility: Pacific Oncology
state: Oregon
city: Memphis
country: United States
facility: The West Clinic
state: Tennessee
city: Nashville
country: United States
facility: Sarah Cannon Cancer Research Institute
state: Tennessee
city: Arlington
country: United States
facility: Arlington Cancer Center
state: Texas
city: Dallas
country: United States
facility: Texax Oncology, P.A., Presbyterian/ Mary Crowley Clinical Research Centers
state: Texas
city: Dallas
country: United States
facility: Mary Crowley Medical Research Center
state: Texas
city: Houston
country: United States
facility: MD Anderson Cancer Center (Protocol 2006-0688)
state: Texas
city: Calgary
country: Canada
facility: Tom Baker Cancer Centre
state: Alberta
city: Halifax
country: Canada
facility: QEII HSC
state: Nova Scotia
city: Toronto
country: Canada
facility: Princess Margaret Hospital
state: Ontario
city: Montreal
country: Canada
facility: Hospital Notre-Dame du Chum
state: Quebec
city: Montreal
country: Canada
facility: Maisonneuve-Rosemont Hospital
state: Quebec
Study officials:
affiliation: Gemin X, Inc.
name: Mark Berger, MD
role: STUDY_DIRECTOR
References:
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.