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Study of SB939 in Subjects With Myelofibrosis

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.
 
ClinicalTrials.gov Identifier: NCT01200498
Recruitment Status : Completed
First Posted : September 13, 2010
Results First Posted : January 30, 2014
Last Update Posted : January 30, 2014
Sponsor:
Collaborator:
S*BIO
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Study Description
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Brief Summary:
The goal of this clinical research study is to learn if SB939 can help to control myelofibrosis. The safety of this drug will also be studied.

Condition or disease Intervention/treatment Phase
Myeloproliferative Disorders Drug: SB939 Phase 2

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Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 23 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 2, Prospective, Open-Label Study to Determine the Safety and Efficacy of SB939, A Histone Deacetylase Inhibitor, in Subjects With Primary, Post-Polycythemia Vera, or Post-Essential Thrombocythemia Myelofibrosis (PMF; Post-Polycythemia Vera (PV) Myelofibrosis (MF), Or Post- Essential Thrombosis (ET) MF
Study Start Date : November 2010
Actual Primary Completion Date : November 2012
Actual Study Completion Date : November 2012

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Arms and Interventions
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Arm Intervention/treatment
Experimental: SB939
SB939 starting dose 60 mg by mouth every other day, three times weekly for 3 weeks.
 Drug: SB939
Starting dose 60 mg by mouth every other day, three times weekly for 3 weeks.


Outcome Measures
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Primary Outcome Measures :
  1. Participants With an Objective Response [ Time Frame: Baseline to 3 Cycles (84 days) ]
    Objective response defined as Complete, Partial response, and Clinical Improvement based on International Working Group (IWG) Criteria: Complete remission (CR): Absence transfusion & growth factor support AND Complete resolution disease-related symptoms/signs; Peripheral blood count remission; Normal leukocyte differential; Bone marrow histological remission. Partial remission (PR): All CR except bone marrow histological remission. Clinical improvement (CI): No CR/PR, disease progression with one: ≥2 g/dL increase hemoglobin level or transfusion independent; Either ≥50% reduction in palpable splenomegaly of spleen ≥10 cm baseline or spleen palpable at >5 cm baseline becomes not palpable; ≥100% increase in platelet count & absolute platelet count ≥50,000 x 10^9/L; or ≥100% increase in absolute neutrophil count (ANC) & ANC ≥0.5 x 10^9/L. Progressive disease: Progressive splenomegaly or Leukemic transformation confirmed by bone marrow blast of ≥20%; or Increase peripheral blood blast


Eligibility Criteria
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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:

  1. Must be equal to or greater than 18 years of age
  2. Must be diagnosed with Primary Myelofibrosis (PMF) or Post-Essential Thrombocythemia (ET) Myelofibrosis (MF) Post-Polycythemia Vera (PV) MF with intermediate-1, intermediate -2 or high risk disease according to the International Working Group (IWG) prognostic scoring system, or if with low risk disease then with symptomatic splenomegaly that is equal to or greater than 5 cm below left costal margin by physical exam.
  3. Must have adequate organ function as demonstrated by the following: • alanine aminotransferase (ALT) (SGOT) and/or aspartate aminotransferase (AST) (SGPT) equal to or less than 2.5 times upper limit of normal (ULN), [unless upon judgment of the treating physician, it is believed to be due to extramedullary hematopoiesis (EMH) related to MF] • Total bilirubin equal to or less than 1.5 times ULN • Serum creatinine equal to or less than 2.5 mg/dL
  4. Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0, 1, or 2
  5. At least 2 weeks from prior MF-directed treatment (till the start of study drug)
  6. Treatment-related toxicities from prior therapies must have resolved to Grade equal to or less than 1
  7. No other active malignancies.
  8. Females of childbearing potential (a sexually mature woman who: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months)).must have negative pregnancy test.

Exclusion Criteria:

  1. Prolongation of the QTc interval to >470 msec at baseline ECG
  2. Known positive status for HIV, or known active hepatitis A, B, or C infection.
  3. Any serious medical condition or psychiatric illness that would prevent, (as judged by the treating physician) the subject from signing the informed consent form or any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study.
  4. Pregnant or lactating females.
  5. Current use of drugs known to prolong QTc interval.
Contacts and Locations
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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): NCT01200498


Locations
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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
S*BIO
Investigators
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Principal Investigator: Alfonso Quintas-Cardama, MD UT MD Anderson Cancer Center
More Information
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Additional Information:

Publications of Results:

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Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT01200498    
Other Study ID Numbers: 2010-0319
First Posted: September 13, 2010    Key Record Dates
Results First Posted: January 30, 2014
Last Update Posted: January 30, 2014
Last Verified: December 2013
Keywords provided by M.D. Anderson Cancer Center:
Primary Polycythemia Vera
Post Polycythemia Vera
Post Essential Thrombocythemia Myelofibrosis
SB939
 PMF
post-PV MF
post-ET MF
Additional relevant MeSH terms:
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Polycythemia Vera
Primary Myelofibrosis
Polycythemia
Myeloproliferative Disorders
Bone Marrow Diseases
 Hematologic Diseases
Bone Marrow Neoplasms
Hematologic Neoplasms
Neoplasms by Site
Neoplasms