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

Phase 1

Completed

• Conditions: Myelofibrosis
• Interventions: Drug: SAR302503 (TG101348)

• Registration Number: NCT00724334
• Lead Sponsor: Bristol-Myers Squibb

Brief 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.

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.

Study Timeline

• Study Start: 2008-07
• Study First Submitted: 2008-07-17
• Study First Submitted QC: 2008-07-25
• Study First Posted: 2008-07-29
• Primary Completion: 2014-05
• Study Completion: 2014-05
• Status Verified: 2016-02
• Disposition First Submitted: 2016-02-17
• Disposition First Submitted QC: 2016-02-17
• Disposition First Posted: 2016-03-17
• Last Update Submitted: 2025-03-03
• Last Update Posted: 2025-03-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 42

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	SAR302503 (TG101348)	-

Primary Outcome Measures

Name	Time	Method
Safety (i.e. adverse events, effects on laboratory parameters, vital signs and ECGs) and tolerability	6 months

Secondary Outcome Measures

Name	Time	Method
Clinical activity and pharmacodynamics	6 months

Trial Locations

Locations (6)

Investigational Site Number 840105; 🇺🇸 Boston, Massachusetts, United States

Investigational Site Number 840102; 🇺🇸 Stanford, California, United States

Investigational Site Number 840103; 🇺🇸 La Jolla, California, United States

Investigational Site Number 840104; 🇺🇸 Rochester, Minnesota, United States

Investigational Site Number 840106; 🇺🇸 Ann Arbor, Michigan, United States

Investigational Site Number 840101; 🇺🇸 Houston, Texas, United States