Study of SB939 in Subjects With Myelofibrosis

Completed · Phase 2

Conditions studied: Myeloproliferative Disorders

In brief

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.

Key facts

Study ID

NCT01200498

Run by

M.D. Anderson Cancer Center

People needed

23

Starts

2010-11-01

Expected to finish

2012-11-01

Last updated by the study team

2014-01-30

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

• UT MD Anderson Cancer Center — Houston, Texas, United States

Full record on ClinicalTrials.gov

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