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Phase 2 N=22 Treatment

Study of SB939 in Subjects With Myelofibrosis

Myeloproliferative Disorders

Enrolled (actual)
22
Serious AEs
4.6%
Results posted
Jan 2014
Primary outcome: Primary: Participants With an Objective Response — 0; 0; 2 Participants

Study Design & Population

Study type
Interventional
Phase
Phase 2
Interventions
SB939 (Drug)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
M.D. Anderson Cancer Center
Primary completion
Nov 2012

Outcome Measures

OutcomeResultp-value
PRIMARY
Participants With an Objective Response
0; 0; 2

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.

Eligibility Criteria

Inclusion Criteria

  • 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 Criteria

  • 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.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01200498). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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