Study of SB939 in Subjects With Myelofibrosis
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|ClinicalTrials.gov Identifier: NCT01200498|
Recruitment Status : Completed
First Posted : September 13, 2010
Results First Posted : January 30, 2014
Last Update Posted : January 30, 2014
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|Condition or disease||Intervention/treatment||Phase|
|Myeloproliferative Disorders||Drug: SB939||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||23 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
SB939 starting dose 60 mg by mouth every other day, three times weekly for 3 weeks.
Starting dose 60 mg by mouth every other day, three times weekly for 3 weeks.
- 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
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- Must be equal to or greater than 18 years of age
- 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.
- 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
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0, 1, or 2
- At least 2 weeks from prior MF-directed treatment (till the start of study drug)
- Treatment-related toxicities from prior therapies must have resolved to Grade equal to or less than 1
- No other active malignancies.
- 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.
- Prolongation of the QTc interval to >470 msec at baseline ECG
- Known positive status for HIV, or known active hepatitis A, B, or C infection.
- 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.
- Pregnant or lactating females.
- Current use of drugs known to prolong QTc interval.
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
|United States, Texas|
|UT MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Alfonso Quintas-Cardama, MD||UT MD Anderson Cancer Center|
Publications of Results:
|Responsible Party:||M.D. Anderson Cancer Center|
|Other Study ID Numbers:||
|First Posted:||September 13, 2010 Key Record Dates|
|Results First Posted:||January 30, 2014|
|Last Update Posted:||January 30, 2014|
|Last Verified:||December 2013|
Primary Polycythemia Vera
Post Polycythemia Vera
Post Essential Thrombocythemia Myelofibrosis
Bone Marrow Diseases
Bone Marrow Neoplasms
Neoplasms by Site