Safety and Efficacy of Obatoclax Mesylate (GX15-070MS) for the Treatment of Hematological Malignancies

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ClinicalTrials.gov Identifier: NCT00438178

Recruitment Status : Completed

First Posted : February 22, 2007

Last Update Posted : May 12, 2014

Sponsor:

Information provided by:

Teva Pharmaceutical Industries

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Hematological Malignancies	Drug: Obatoclax mesylate (GX15-070MS)	Phase 1

Detailed Description:

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.

Study Design


Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	44 participants
Allocation:	Non-Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	A Phase I Study of Obatoclax Mesylate (GX15-070MS) in 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
Study Start Date :	October 2005
Actual Primary Completion Date :	October 2007

Resource links provided by the National Library of Medicine

Genetics Home Reference related topics: Chronic myeloid leukemia Core binding factor acute myeloid leukemia Cytogenetically normal acute myeloid leukemia Familial acute myeloid leukemia with mutated CEBPA Primary myelofibrosis

Genetic and Rare Diseases Information Center resources: Myelodysplastic Syndromes Myeloid Leukemia Acute Myeloid Leukemia Acute Non Lymphoblastic Leukemia Chronic Myeloid Leukemia Chronic Lymphocytic Leukemia Leukemia, B-cell, Chronic Myelofibrosis Aplastic Anemia

U.S. FDA Resources

Arms and Interventions

Outcome Measures

Primary Outcome Measures :

Determine the recommended Phase II dose of GX15-070MS; Characterize the DLTs of GX15-070MS; Determine the PK/PD response to GX15-070MS

Secondary Outcome Measures :

Describe any clinical responses of patient with hematological malignancies.

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00438178

Locations


United States, District of Columbia
Georgetown University Medical Center
Washington, District of Columbia, United States, 20007
United States, Texas
MD Anderson Cancer Center
Houston, Texas, United States, 77030
Canada, Ontario
Princess Margaret Hospital
Toronto, Ontario, Canada, M5G 2M9

Sponsors and Collaborators

Gemin X

Investigators


Study Director:	Jean Viallet, MD	Gemin X, Inc.

More Information

Publications of Results:

Schimmer AD, O'Brien S, Kantarjian H, Brandwein J, Cheson BD, Minden MD, Yee K, Ravandi F, Giles F, Schuh A, Gupta V, Andreeff M, Koller C, Chang H, Kamel-Reid S, Berger M, Viallet J, Borthakur G. A phase I study of the pan bcl-2 family inhibitor obatoclax mesylate in patients with advanced hematologic malignancies. Clin Cancer Res. 2008 Dec 15;14(24):8295-301. doi: 10.1158/1078-0432.CCR-08-0999.


Responsible Party:	Jean Viallet, MD / Chief Medical Officer, Gemin X Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00438178 History of Changes
Other Study ID Numbers:	GX006
First Posted:	February 22, 2007 Key Record Dates
Last Update Posted:	May 12, 2014
Last Verified:	May 2014

Additional relevant MeSH terms:


Neoplasms

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