Study of SB939 in Subjects With Myelofibrosis

NCT01200498 | Completed Phase 2 Results

• 1 other identifier: 2010-0319
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

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.

Conditions

Myeloproliferative Disorders

Keywords

Primary Polycythemia Vera; Post Polycythemia Vera; Post Essential Thrombocythemia Myelofibrosis; SB939; PMF; post-PV MF; post-ET MF

Outcome Measures

Primary Outcomes (1)

• Participants With an Objective Response

  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

  Baseline to 3 Cycles (84 days)

Study Arms (1)

SB939

EXPERIMENTAL

SB939 starting dose 60 mg by mouth every other day, three times weekly for 3 weeks.

Drug: SB939

Interventions

SB939 DRUG

Starting dose 60 mg by mouth every other day, three times weekly for 3 weeks.

SB939

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• S*BIO: collaborator

Study Sites (1)

UT MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Publications (1)

• Quintas-Cardama A, Kantarjian H, Estrov Z, Borthakur G, Cortes J, Verstovsek S. Therapy with the histone deacetylase inhibitor pracinostat for patients with myelofibrosis. Leuk Res. 2012 Sep;36(9):1124-7. doi: 10.1016/j.leukres.2012.03.003. Epub 2012 Apr 2.

  PMID: 22475363 RESULT

Related Links

• UT MD Anderson Cancer Center official website

MeSH Terms

Conditions

Myeloproliferative Disorders

Condition Hierarchy (Ancestors)

Bone Marrow Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases

Results Point of Contact

• Title: Alfonso Quintas-Cardama, MD/Assistant Professor
• Organization: The University of Texas MD Anderson Cancer Center

eharriso@mdanderson.org

713-745-4009

Study Officials

• Alfonso Quintas-Cardama, MD

  UT MD Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

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

Study Record Dates

• First Submitted: September 9, 2010
• First Posted: September 13, 2010
• Study Start: November 1, 2010
• Primary Completion: November 1, 2012
• Study Completion: November 1, 2012
• Last Updated: January 30, 2014
• Results First Posted: January 30, 2014

Record last verified: 2013-12

Locations

US (1)