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

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 2; Phase 1

Conditions: Myelofibrosis

Treatments: Drug: SAR302503 (TG101348)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00724334

MF-TG101348-002 (Other Identifier)

TED12015

Details and patient eligibility

About

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.

Full 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.

Enrollment: 42 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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42 participants in 1 patient group

1

Experimental group

Treatment:

Drug: SAR302503 (TG101348)