An Open-Label Study to Evaluate the Long-Term Effects of Orally Administered SAR302503 in Patients With Primary or Secondary Myelofibrosis
18 Years
N/A
Both
Myelofibrosis
Trial Information
An Open-Label Study to Evaluate the Long-Term Effects of Orally Administered SAR302503 in Patients With Primary or Secondary Myelofibrosis
SAR302503 (TG101348) is a potent small molecule inhibitor of Janus kinase 2 (JAK2). This is
an extension study for a first-in-man, dose escalation study (MF-TG101348-001). The safety,
tolerability and clinical activity of SAR302503 (TG101348) in subjects with myelofibrosis
will be evaluated.
Inclusion Criteria:
- Completion of MF-TG101348-001 study
- Diagnosis of myelofibrosis
- At least 18 years of age
Exclusion Criteria:
- Any acute or chronic medical abnormality that may increase the risk associated with
study participation
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Safety (i.e. adverse events, effects on laboratory parameters, vital signs and ECGs) and tolerability
Outcome Time Frame:
6 months
Safety Issue:
Yes
Principal Investigator
Ayalew Tefferi, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Mayo Clinic, Rochester, MN
Authority:
United States: Food and Drug Administration
Study ID:
TED12015
NCT ID:
NCT00724334
Start Date:
July 2008
Completion Date:
December 2013
Related Keywords:
- Myelofibrosis
- myelofibrosis
- Primary Myelofibrosis
Name | Location |
|---|---|
| MD Anderson Cancer Center | Houston, Texas 77030-4096 |
| University of Michigan Comprehensive Cancer Center | Ann Arbor, Michigan 48109-0752 |
| Dana Farber Cancer Institute | Boston, Massachusetts 02115 |
| UCSD Moores Cancer Center | La Jolla, California 93093 |
| Mayo Clinic, Rochester | Rochester, Minnesota 55905 |
| Stanford Comprehensive Cancer Center | Stanford, California 94305 |
