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Obatoclax for Systemic Mastocytosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00918931
Recruitment Status : Terminated
First Posted : June 11, 2009
Results First Posted : April 25, 2011
Last Update Posted : November 4, 2011
Gemin X
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Brief Summary:
The goal of this clinical research study is to learn if obatoclax mesylate can help to control systemic mastocytosis. The safety of this drug will also be tested.

Condition or disease Intervention/treatment Phase
Leukemia Systemic Mastocytosis Drug: Obatoclax Mesylate Phase 2

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of Obatoclax Mesylate as Therapy for Patients With Systemic Mastocytosis
Study Start Date : June 2009
Actual Primary Completion Date : October 2010
Actual Study Completion Date : October 2010

Arm Intervention/treatment
Experimental: Obatoclax Mesylate
30 mg by vein over 3 hours Days 1-3, 14-day cycle
Drug: Obatoclax Mesylate
30 mg given by vein over 3 hours on Days 1-3 of each 14-day study cycle.

Primary Outcome Measures :
  1. Response Rate [ Time Frame: 3-Month Response Evaluation ]
    Response rate is defined as number of participants with objective response divided by number of participants evaluated. Objective response is complete response and partial response where 'complete response' constitutes total elimination of a symptom or sign of the disease; 'partial response' constitutes at least 50% improvement in a symptom or sign of the disease. Objective response definitions of response evaluated following guidelines proposed by Valent et al. (International working group consensus 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

Inclusion Criteria:

  1. Patients with Systemic Mastocytosis (SM); including mast cell leukemia.
  2. Age equal to or greater than 18 years
  3. Minimum of two weeks since any major surgery or completion of radiation
  4. Eastern Cooperative Oncology Group (ECOG) performance status equal to or less than 2
  5. Adequate liver function as shown by serum bilirubin equal to or less than 1.5 * upper limit of normal (ULN), and serum alanine aminotransferase (ALT) equal to or less than 3 * ULN.
  6. Signed informed consent

Exclusion Criteria:

  1. Patients with low blood cell counts (Grade 3 or 4), unless it is known that the low blood cell count is due to systemic mastocytosis.
  2. Treatment with any conventional (specifically, interferon or cladribine) or investigational medicine for SM within the preceding 4 weeks
  3. Chronic treatment with systemic steroids (unless limited to 10 mg prednisone equivalent per day or less) or another immunosuppressive agent
  4. Other malignancies within the past 3 years except for adequately treated carcinoma of the cervix or basal or squamous cell carcinomas of the skin. Patient may have SM-associated clonal hematologic disease that does not require therapy, as judged by the treating physician and approved by the principal investigator).
  5. Other concurrent severe and/or uncontrolled medical disease which could compromise participation in the study as judged by the Principal Investigator (i.e., severely impaired lung function, uncontrolled diabetes, uncontrolled hypertension, severe infection, severe malnutrition, unstable angina, or congestive heart failure - New York Heart Association Class III or IV, ventricular arrhythmias, active ischemic heart disease, myocardial infarction within six months, chronic liver or renal disease, active upper GI tract ulceration)
  6. A known history of human immunodeficiency virus (HIV) seropositivity
  7. Women who are pregnant or breast feeding,or women/men able to conceive and unwilling to practice an effective method of birth control. Women of childbearing potential must have a negative urine or serum pregnancy test within 48 hours prior to administration of obatoclax. Women of childbearing potential is defined as women who have not undergone a hysterectomy or bilateral oophorectomy, has not been naturally postmenopausal for at least 24 consecutive months.
  8. Patients with a known hypersensitivity to obatoclax mesylate or to its excipients (PEG 300 and Tween 20)
  9. Patients unwilling to or unable to comply with the protocol

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 identifier (NCT number): NCT00918931

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United States, Texas
UT MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Gemin X
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Study Chair: Srdan Verstovsek, MD UT MD Anderson Cancer Center

Additional Information:
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Responsible Party: M.D. Anderson Cancer Center Identifier: NCT00918931     History of Changes
Other Study ID Numbers: 2008-0792
First Posted: June 11, 2009    Key Record Dates
Results First Posted: April 25, 2011
Last Update Posted: November 4, 2011
Last Verified: October 2011
Keywords provided by M.D. Anderson Cancer Center:
Systemic Mastocytosis
Obatoclax mesylate
Additional relevant MeSH terms:
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Mastocytosis, Systemic
Neoplasms by Histologic Type
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Skin Diseases
Immune Complex Diseases
Immune System Diseases
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action