Basic Trial Information
Trial Description
     Summary
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Treatment	Closed	18 and over	Pharmaceutical / Industry	GEM013 NCT00413114

Trial Description

Summary

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

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

Trial Contact Information

Trial Lead Organizations/Sponsors

Gemin X Biotechnologies

Mark Stanley Berger

Study Director

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00413114
Information obtained from ClinicalTrials.gov on March 18, 2009