Obatoclax for Systemic Mastocytosis

NCT00918931 | Terminated Phase 2 Results

• 1 other identifier: 2008-0792
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

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.

Conditions

Leukemia; Systemic Mastocytosis

Keywords

Leukemia; Systemic Mastocytosis; SM; Obatoclax mesylate; GX15-070MS

Outcome Measures

Primary Outcomes (1)

• Response Rate

  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).

  3-Month Response Evaluation

Study Arms (1)

Obatoclax Mesylate

EXPERIMENTAL

30 mg by vein over 3 hours Days 1-3, 14-day cycle

Drug: Obatoclax Mesylate

Interventions

Obatoclax Mesylate DRUG

30 mg given by vein over 3 hours on Days 1-3 of each 14-day study cycle.

Obatoclax Mesylate

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with Systemic Mastocytosis (SM); including mast cell leukemia.
• Age equal to or greater than 18 years
• Minimum of two weeks since any major surgery or completion of radiation
• Eastern Cooperative Oncology Group (ECOG) performance status equal to or less than 2
• 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.
• Signed informed consent

You may not qualify if:

• 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.
• Treatment with any conventional (specifically, interferon or cladribine) or investigational medicine for SM within the preceding 4 weeks
• Chronic treatment with systemic steroids (unless limited to 10 mg prednisone equivalent per day or less) or another immunosuppressive agent
• 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).
• 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)
• A known history of human immunodeficiency virus (HIV) seropositivity
• 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.
• Patients with a known hypersensitivity to obatoclax mesylate or to its excipients (PEG 300 and Tween 20)
• Patients unwilling to or unable to comply with the protocol

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• Gemin X: collaborator

Study Sites (1)

UT MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• UT MD Anderson Cancer Center website

MeSH Terms

Conditions

Leukemia; Mastocytosis, Systemic

Interventions

obatoclax

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Mastocytosis; Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Mast Cell Activation Disorders; Immune System Diseases

Results Point of Contact

• Title: Srdan Verstovsek M.D./Associate Professor
• Organization: Organization: The University of Texas M. D. Anderson Cancer Center

eharriso@mdanderson.org

713-792-7305

Study Officials

• Srdan Verstovsek, MD

  UT MD Anderson Cancer Center

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 9, 2009
• First Posted: June 11, 2009
• Study Start: June 1, 2009
• Primary Completion: October 1, 2010
• Study Completion: October 1, 2010
• Last Updated: November 4, 2011
• Results First Posted: April 25, 2011

Record last verified: 2011-10

Locations

US (1)