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

February 17, 2016 updated by: Sanofi

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

42

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • La Jolla, California, United States, 92093
        • Investigational Site Number 840103
      • Stanford, California, United States, 94305
        • Investigational Site Number 840102
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Investigational Site Number 840105
    • Michigan
      • Ann Arbor, Michigan, United States, 48109-0759
        • Investigational Site Number 840106
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Investigational Site Number 840104
    • Texas
      • Houston, Texas, United States, 77030
        • Investigational Site Number 840101

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Drug: SAR302503 (TG101348)
orally administered, once a day

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
Clinical activity and pharmacodynamics
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sanofi

Investigators

  • Study Chair: Ayalew Tefferi, MD, Mayo Clinic, Rochester, MN

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2008

Primary Completion (Actual)

May 1, 2014

Study Completion (Actual)

May 1, 2014

Study Registration Dates

First Submitted

July 17, 2008

First Submitted That Met QC Criteria

July 25, 2008

First Posted (Estimate)

July 29, 2008

Study Record Updates

Last Update Posted (Estimate)

March 17, 2016

Last Update Submitted That Met QC Criteria

February 17, 2016

Last Verified

February 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TED12015
  • MF-TG101348-002 (Other Identifier: Targegen)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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