Status:
COMPLETED
Study of SB939 in Subjects With Myelofibrosis
Lead Sponsor:
M.D. Anderson Cancer Center
Collaborating Sponsors:
S*BIO
Conditions:
Myeloproliferative Disorders
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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.
Detailed Description
The Study Drug: SB939 is designed to change the DNA (genetic material) of cancer cells. This may keep the cells from growing and cause them to die. This is the first study in which SB939 is given to...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
November 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2012
Estimated Enrollment :
23 Patients enrolled
Trial Details
Trial ID
NCT01200498
Start Date
November 1 2010
End Date
November 1 2012
Last Update
January 30 2014
Active Locations (1)
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1
UT MD Anderson Cancer Center
Houston, Texas, United States, 77030