Study of SB939 in Subjects With Myelofibrosis
This study has been completed.
Sponsor:
M.D. Anderson Cancer Center
Collaborator:
S*BIO
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT01200498
First received: September 9, 2010
Last updated: November 14, 2012
Last verified: November 2012
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Myeloproliferative Disorders |
Drug: SB939 |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase 2, Prospective, Open-Label Study to Determine the Safety and Efficacy of SB939, A Histone Deacetylase Inhibitor, in Subjects With Primary, Post-Polycythemia Vera, or Post-Essential Thrombocythemia Myelofibrosis (PMF; Post-PV MF, Or Post-ET MF |
Resource links provided by NLM:
Genetics Home Reference related topics:
essential thrombocythemia
polycythemia vera
primary myelofibrosis
U.S. FDA Resources
Further study details as provided by M.D. Anderson Cancer Center:
Primary Outcome Measures:
- Objective Response Rate [ Time Frame: Every 4-week cycle ] [ Designated as safety issue: Yes ]Objective response rate is complete and partial response, and clinical improvement.
| Enrollment: | 23 |
| Study Start Date: | November 2010 |
| Primary Completion Date: | November 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: SB939
SB939 starting dose 60 mg by mouth every other day, 3 times weekly for 3 weeks.
|
Drug: SB939
Starting dose 60 mg by mouth every other day, 3 times weekly for 3 weeks.
|
Show Detailed Description
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Must be equal to or greater than 18 years of age
- Must be diagnosed with PMF or post ET/PV MF with intermediate-1, intermediate -2 or high risk disease according to the 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: • ALT (SGOT) and/or AST (SGPT) equal to or less than 2.5x 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 x ULN • Serum creatinine equal to or less than 2.5 mg/dL
- 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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01200498
Locations
| United States, Texas | |
| UT MD Anderson Cancer Center | |
| Houston, Texas, United States, 77030 | |
Sponsors and Collaborators
M.D. Anderson Cancer Center
S*BIO
Investigators
| Principal Investigator: | Alfonso Quintas-Cardama, MD | UT MD Anderson Cancer Center |
More Information
Additional Information:
No publications provided
| Responsible Party: | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT01200498 History of Changes |
| Other Study ID Numbers: | 2010-0319 |
| Study First Received: | September 9, 2010 |
| Last Updated: | November 14, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by M.D. Anderson Cancer Center:
|
Primary Polycythemia Vera Post Polycythemia Vera Post Essential Thrombocythemia Myelofibrosis SB939 |
PMF post-PV MF post-ET MF |
Additional relevant MeSH terms:
|
Primary Myelofibrosis Myeloproliferative Disorders Polycythemia Polycythemia Vera Thrombocythemia, Essential Thrombocytosis Bone Marrow Diseases Hematologic Diseases |
Blood Coagulation Disorders Blood Platelet Disorders Hemorrhagic Disorders Histone Deacetylase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 22, 2013