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

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

Status

Completed

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00724334

Enrollment

Registered

2008-07-29

Start date

2008-07-31

Completion date

2014-05-31

Last updated

2025-03-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Myelofibrosis

Keywords

myelofibrosis

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.

Interventions

DRUGSAR302503 (TG101348)

orally administered, once a day

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

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

Secondary

Measure	Time frame
Clinical activity and pharmacodynamics	6 months

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 10, 2026