A Long-Term Study of the Effects of Orally Administered SAR302503 in Patients With Myelofibrosis

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT00724334
First received: July 17, 2008
Last updated: April 7, 2014
Last verified: April 2014

July 17, 2008
April 7, 2014
July 2008
April 2014   (final data collection date for primary outcome measure)
Safety (i.e. adverse events, effects on laboratory parameters, vital signs and ECGs) and tolerability [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00724334 on ClinicalTrials.gov Archive Site
Clinical activity and pharmacodynamics [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Clinical activity and pharacodynamics [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
A Long-Term Study of the Effects of Orally Administered SAR302503 in Patients With Myelofibrosis
An Open-Label Study to Evaluate the Long-Term Effects of Orally Administered SAR302503 in Patients With Primary or Secondary Myelofibrosis

The purpose of this study is to evaluate the long-term effects of orally administered SAR302503 (TG101348) in patients with myelofibrosis who have completed the MF-TG101348-001 study.

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.

Interventional
Phase 1
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Myelofibrosis
Drug: SAR302503 (TG101348)
orally administered, once a day
Experimental: 1
Intervention: Drug: SAR302503 (TG101348)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
60
April 2014
April 2014   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00724334
TED12015, MF-TG101348-002
No
Sanofi
Sanofi
Not Provided
Study Chair: Ayalew Tefferi, MD Mayo Clinic, Rochester, MN
Sanofi
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP