Study of SB939 in Subjects With Myelofibrosis

This study has been completed.
Sponsor:
Collaborator:
S*BIO
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT01200498
First received: September 9, 2010
Last updated: December 13, 2013
Last verified: December 2013
  Purpose

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 Intervention Phase
Myeloproliferative Disorders
Drug: SB939
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • Participants With an Objective Response [ Time Frame: Baseline to 3 Cycles (84 days) ] [ Designated as safety issue: No ]
    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


Enrollment: 23
Study Start Date: November 2010
Study Completion Date: November 2012
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01200498

Locations
United States, Texas
UT MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
S*BIO
Investigators
Principal Investigator: Alfonso Quintas-Cardama, MD UT MD Anderson Cancer Center
  More Information

Additional Information:
Publications:
Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT01200498     History of Changes
Other Study ID Numbers: 2010-0319
Study First Received: September 9, 2010
Results First Received: December 13, 2013
Last Updated: December 13, 2013
Health Authority: United States: Food and Drug Administration

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:
Primary Myelofibrosis
Myeloproliferative Disorders
Polycythemia
Polycythemia Vera
Thrombocythemia, Essential
Thrombocytosis
Bone Marrow Diseases
Hematologic Diseases
Blood Coagulation Disorders
Blood Platelet Disorders
Hemorrhagic Disorders
Histone Deacetylase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 26, 2014