Overview

Study of SB939 in Subjects With Myelofibrosis

Status:
Completed

Trial end date:
2012-11-01

Target enrollment:
0

Participant gender:
All

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.

Phase:

Phase 2

Accepts Healthy Volunteers?

Details

Lead Sponsor:

M.D. Anderson Cancer Center

Collaborator:

S*BIO

Treatments:

Histone Deacetylase Inhibitors

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.