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

NCT ID: NCT00438178

Last Updated: 2014-05-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 44 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-10-31

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.

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.

Conditions

Hematological Malignancies

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

Obatoclax mesylate (GX15-070MS)

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Gemin X

INDUSTRY

Sponsor Role: lead

Responsible Party

Gemin X Pharmaceuticals

Principal Investigators

Jean Viallet, MD

Role: STUDY_DIRECTOR

Gemin X, Inc.

Locations

Georgetown University Medical Center

Washington D.C., District of Columbia, United States

MD Anderson Cancer Center

Houston, Texas, United States

Princess Margaret Hospital

Toronto, Ontario, Canada

Countries

United States; Canada

References

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.

Reference Type: RESULT

PMID: 19088047 (View on PubMed)

Other Identifiers

GX006

Identifier Type: -

Identifier Source: org_study_id