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

Sponsored by:	Gemin X
Information provided by:	Gemin X
ClinicalTrials.gov Identifier:	NCT00413114

Purpose

Defects in the apoptotic process can lead to the onset of cancer by allowing cells to grow unchecked when an oncogneic 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	Intervention	Phase
Myelodysplastic Syndromes	Drug: Obatoclax mesylate (GX15-070MS)	Phase II

MedlinePlus related topics: Anemia Cancer

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	A Phase II Study of Obatoclax Mesylate (GX15-070MS) in Patients With Previously-Untreated Myelodysplastic Syndromes (MDS) With Anemia and/or Thrombocytopenia

Further study details as provided by Gemin X:

Primary Outcome Measures:

Determine the response rate to obatoclax and characterize the safety profile.

Secondary Outcome Measures:

Peripheral blood counts; Bone marrow aspirates and biopsies; Transfusions and growth factor requirements

Estimated Enrollment:	55
Study Start Date:	December 2006
Estimated Study Completion Date:	August 2009
Estimated Primary Completion Date:	August 2009 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00413114

Show 22 Study Locations

Sponsors and Collaborators

Gemin X

Investigators

Study Director:

Mark Berger, MD

Gemin X, Inc.

More Information

Study ID Numbers:	GEM013
Study First Received:	December 18, 2006
Last Updated:	September 12, 2008
ClinicalTrials.gov Identifier:	NCT00413114
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Myelodysplastic syndromes
Preleukemia
Thrombocytopenia
Precancerous Conditions
Hematologic Diseases

Myelodysplasia
Myelodysplastic Syndromes
Anemia
Bone Marrow Diseases

Additional relevant MeSH terms:

Neoplasms
Pathologic Processes
Disease
Syndrome

ClinicalTrials.gov processed this record on January 14, 2009