Sorafenib in Myelodysplastic Syndrome
This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
First received: July 30, 2007
Last updated: October 2, 2012
Last verified: August 2012
The purpose of this study is to evaluate whether sorafenib can increase blood counts, decrease transfusion needs, and slow abnormal blood cell formation or development of leukemia in people with Myelodysplastic Syndrome (MDS).
Leukemia, Myelomonocytic, Chronic
||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
||Phase II Trial of Sorafenib in Patients With Myelodysplastic Syndrome
Primary Outcome Measures:
- Hematological response [ Time Frame: 5 years ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Dose reductions [ Time Frame: while on study drug ] [ Designated as safety issue: Yes ]
- Time to progression [ Time Frame: 5 years ] [ Designated as safety issue: No ]
| Estimated Enrollment:
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||October 2012 (Final data collection date for primary outcome measure)
Experimental: all patients
400 mg twice a day until progression or unacceptable toxicity develops.
Other Name: Nexavar
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- Female subject is pregnant or lactating. Confirmation that the subject is not pregnant must be established by a negative serum B-human chorionic gonadotropin (B-hCG) pregnancy test result within 2 weeks of enrollment. Pregnancy testing is not required for post-menopausal or surgically sterilized women.
- Patient has received other investigational drugs for this disease within 14 days of enrollment
- No growth factor support with erythropoietin, GCSF, or GMCSF within 28 days of enrolling in the study.
- Serious medical or psychiatric illness likely to interfere with participation in this clinical study.
- Patients with another malignancy within the last one year (from documentation of remission) other than basal or squamous cell skin cancer or CIS of the cervix.
- Patients who underwent allogeneic stem cell transplant will be excluded.
- History of leukemia (having more than 20% blasts in blood or marrow)
- Current treatment with coumadin, heparin and its derivatives.
- Major surgery (including needle biopsy of visceral organs) for 1-month prior to study and fully recovered. In addition, no placement of a subcutaneous or tunneled venous access device for 3 days prior to study and adequately healed.
- Significant cardiac or vascular events within 6 months: acute MI, unstable angina, severe peripheral vascular disease (ischemic pain at rest class 3 or worse, non-healing ulcers/wounds, congestive heart failure (NHYA class ≥ 2), uncontrolled cardiac arrhythmias, and disseminated intravascular coagulation.
- No use of hematopoetic growth factors within 4 weeks of starting sorafenib.
- Known severe hypersensitivity to Sorafenib or any component of the formulation.
- Caution should be exercised with the concomitant use of other CYP3A4 inducers, such as rifampin, St. John's Wort, phenytoin, phenobarbital and dexamethasone.
- Uncontrolled hypertension with a systolic blood pressure greater than 160 or a diastolic blood pressure greater than 100 despite treatment.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00510289
|Duke University Medical Center
|Durham, North Carolina, United States, 27710 |
||David A Rizzieri, MD
No publications provided
History of Changes
|Other Study ID Numbers:
|Study First Received:
||July 30, 2007
||October 2, 2012
||United States: Institutional Review Board
Keywords provided by Duke University:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on May 23, 2013
Leukemia, Myelomonocytic, Chronic
Neoplasms by Histologic Type
Bone Marrow Diseases
Protein Kinase Inhibitors
Molecular Mechanisms of Pharmacological Action