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

This study has been completed.
Sponsor:
Information provided by:
Gemin X
ClinicalTrials.gov Identifier:
NCT00438178
First received: February 21, 2007
Last updated: September 15, 2010
Last verified: September 2010
History of Changes
  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.


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

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Gemin X:

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.

Enrollment: 44
Study Start Date: October 2005
Primary Completion Date: October 2007 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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:

Responsible Party: Jean Viallet, MD / Chief Medical Officer, Gemin X Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00438178     History of Changes
Other Study ID Numbers: GX006
Study First Received: February 21, 2007
Last Updated: September 15, 2010
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Neoplasms
Leukemia, Lymphocytic, Chronic, B-Cell
Leukemia, Myeloid
Myelodysplastic Syndromes
Hematologic Neoplasms
Leukemia, B-Cell
Leukemia, Lymphoid
Leukemia
 Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Bone Marrow Diseases
Hematologic Diseases
Neoplasms by Site

ClinicalTrials.gov processed this record on May 19, 2013