Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase I	Treatment	Completed	18 and over	Pharmaceutical / Industry	GX006 NCT00438178

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.

Further Study Information

This is a multi-center, open-label, Phase I study of obatoclax administered every 2-week or weekly cycles, or as a Prolonged Infusion every 2 to 3 weeks to patients with Acute Myeloid Leukemia (AML), Myelodysplastic Syndrome (MDS), Chronic Myeloid Leukemia (CML)in Myeloid Blast Phase, Myelofibrosis, Previously-Treated Chronic Lymphocytic Leukemia (CLL), or Aplastic Anemia. Due to the PK/PD sampling schedule Cycle 1 will require overnight hospitalization. For the following cycles treatment may be administered on an outpatient basis but is at the discretion of the investigator. No investigational or commercial agents or therapies other than those described within the protocol may be administered with the intent to treat the patient's malignancy. Supportive care measures including those directed at controlling symptoms resulting from hematological malignancies are allowed.

Eligibility Criteria

Inclusion Criteria:

• Histologically or cytologically confirmation of AML, MDS, CML in blast phase, myelofibrosis, CLL, or aplastic anemia

• There are no limitations on additional, allowable type and amount of prior therapy as long as acute toxicities have resolved to the allowable grade.

• Must have normal organ functions

• Must be willing to submit to blood sampling for the planned PK and PD analyses.

• Must have the ability to understand and willingness to sign a written informed consent form

Exclusion Criteria:

• No other agents or therapies administered for 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

Jean Viallet, MD

Study Director

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00438178
Information obtained from ClinicalTrials.gov on March 18, 2009