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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
  Purpose
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.

Condition Intervention Phase
Myelofibrosis Drug: SAR302503 (TG101348) Phase 1 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-Label Study to Evaluate the Long-Term Effects of Orally Administered SAR302503 in Patients With Primary or Secondary Myelofibrosis

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Safety (i.e. adverse events, effects on laboratory parameters, vital signs and ECGs) and tolerability [ Time Frame: 6 months ]

Secondary Outcome Measures:
  • Clinical activity and pharmacodynamics [ Time Frame: 6 months ]

Enrollment: 42
Study Start Date: July 2008
Study Completion Date: May 2014
Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: SAR302503 (TG101348)
orally administered, once a day

Detailed Description:
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.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00724334


Locations
United States, California
Investigational Site Number 840103
La Jolla, California, United States, 92093
Investigational Site Number 840102
Stanford, California, United States, 94305
United States, Massachusetts
Investigational Site Number 840105
Boston, Massachusetts, United States, 02115
United States, Michigan
Investigational Site Number 840106
Ann Arbor, Michigan, United States, 48109-0759
United States, Minnesota
Investigational Site Number 840104
Rochester, Minnesota, United States, 55905
United States, Texas
Investigational Site Number 840101
Houston, Texas, United States, 77030
Sponsors and Collaborators
Sanofi
Investigators
Study Chair: Ayalew Tefferi, MD Mayo Clinic, Rochester, MN
  More Information

Additional Information:
Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT00724334     History of Changes
Other Study ID Numbers: TED12015
MF-TG101348-002 ( Other Identifier: Targegen )
First Submitted: July 17, 2008
First Posted: July 29, 2008
Last Update Posted: March 17, 2016
Last Verified: February 2016

Keywords provided by Sanofi:
myelofibrosis

Additional relevant MeSH terms:
Primary Myelofibrosis
Myeloproliferative Disorders
Bone Marrow Diseases
Hematologic Diseases