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

NCT ID: NCT00724334

Last Updated: 2025-03-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-07-31

Study Completion Date

2014-05-31

Brief Summary

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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

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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.

Conditions

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Myelofibrosis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Group Type EXPERIMENTAL

SAR302503 (TG101348)

Intervention Type DRUG

orally administered, once a day

Interventions

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SAR302503 (TG101348)

orally administered, once a day

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bristol-Myers Squibb

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ayalew Tefferi, MD

Role: STUDY_CHAIR

Mayo Clinic, Rochester, MN

Locations

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Investigational Site Number 840103

La Jolla, California, United States

Site Status

Investigational Site Number 840102

Stanford, California, United States

Site Status

Investigational Site Number 840105

Boston, Massachusetts, United States

Site Status

Investigational Site Number 840106

Ann Arbor, Michigan, United States

Site Status

Investigational Site Number 840104

Rochester, Minnesota, United States

Site Status

Investigational Site Number 840101

Houston, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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MF-TG101348-002

Identifier Type: OTHER

Identifier Source: secondary_id

TED12015

Identifier Type: -

Identifier Source: org_study_id

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