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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00724334
First Posted: July 29, 2008
Last Update Posted: March 17, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Sanofi
July 17, 2008
July 29, 2008
March 17, 2016
July 2008
May 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 ]
Same as current
Complete list of historical versions of study NCT00724334 on ClinicalTrials.gov Archive Site
Clinical activity and pharmacodynamics [ Time Frame: 6 months ]
Clinical activity and pharacodynamics [ Time Frame: 6 months ]
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
Intervention Model: Single Group Assignment
Masking: None (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.
 
Completed
42
May 2014
May 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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00724334
TED12015
MF-TG101348-002 ( Other Identifier: Targegen )
No
Not Provided
Not Provided
Sanofi
Sanofi
Not Provided
Study Chair: Ayalew Tefferi, MD Mayo Clinic, Rochester, MN
Sanofi
February 2016

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