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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:
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT00724334
First received: July 17, 2008
Last updated: July 17, 2014
Last verified: July 2014
  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
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Clinical activity and pharmacodynamics [ Time Frame: 6 months ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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:
No publications provided

Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT00724334     History of Changes
Other Study ID Numbers: TED12015, MF-TG101348-002
Study First Received: July 17, 2008
Last Updated: July 17, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Sanofi:
myelofibrosis

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

ClinicalTrials.gov processed this record on November 25, 2014