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NCT00724334 Clinical Trial

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

Myelofibrosis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00724334
Other study ID # TED12015
Secondary ID MF-TG101348-002
Status Completed
Phase Phase 1/Phase 2
First received July 17, 2008
Last updated February 17, 2016
Start date July 2008
Est. completion date May 2014

Study information
Verified date February 2016
Source Sanofi
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 42
Est. completion date May 2014
Est. primary completion date May 2014
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• SAR302503 (TG101348)
orally administered, once a day

Locations
Country Name City State
United States Investigational Site Number 840106 Ann Arbor Michigan
United States Investigational Site Number 840105 Boston Massachusetts
United States Investigational Site Number 840101 Houston Texas
United States Investigational Site Number 840103 La Jolla California
United States Investigational Site Number 840104 Rochester Minnesota
United States Investigational Site Number 840102 Stanford California

Sponsors (1)
Lead Sponsor Collaborator
Sanofi

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Safety (i.e. adverse events, effects on laboratory parameters, vital signs and ECGs) and tolerability 6 months Yes
Secondary Clinical activity and pharmacodynamics 6 months No
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