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An Open-Label Study to Evaluate the Long-Term Effects of Orally Administered SAR302503 in Patients With Primary or Secondary Myelofibrosis


Phase 1/Phase 2
18 Years
N/A
Open (Enrolling)
Both
Myelofibrosis

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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 CenterHouston, Texas  77030-4096
University of Michigan Comprehensive Cancer CenterAnn Arbor, Michigan  48109-0752
Dana Farber Cancer InstituteBoston, Massachusetts  02115
UCSD Moores Cancer CenterLa Jolla, California  93093
Mayo Clinic, RochesterRochester, Minnesota  55905
Stanford Comprehensive Cancer CenterStanford, California  94305