Back to resultsA Long-Term Study of the Effects of Orally Administered SAR302503 in Patients With Myelofibrosis
Primary Purpose
Myelofibrosis
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
SAR302503 (TG101348)
Sponsored by
About this trial
This is an interventional treatment trial for Myelofibrosis focused on measuring myelofibrosis
Eligibility Criteria
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
Sites / Locations
- Investigational Site Number 840103
- Investigational Site Number 840102
- Investigational Site Number 840105
- Investigational Site Number 840106
- Investigational Site Number 840104
- Investigational Site Number 840101
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
1
Arm Description
Outcomes
Primary Outcome Measures
Safety (i.e. adverse events, effects on laboratory parameters, vital signs and ECGs) and tolerability
Secondary Outcome Measures
Clinical activity and pharmacodynamics
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00724334
Brief Title
A Long-Term Study of the Effects of Orally Administered SAR302503 in Patients With Myelofibrosis
Official Title
An Open-Label Study to Evaluate the Long-Term Effects of Orally Administered SAR302503 in Patients With Primary or Secondary Myelofibrosis
Study Type
Interventional
2. Study Status
Record Verification Date
February 2016
Overall Recruitment Status
Completed
Study Start Date
July 2008 (undefined)
Primary Completion Date
May 2014 (Actual)
Study Completion Date
May 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sanofi
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myelofibrosis
Keywords
myelofibrosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
42 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
SAR302503 (TG101348)
Intervention Description
orally administered, once a day
Primary Outcome Measure Information:
Title
Safety (i.e. adverse events, effects on laboratory parameters, vital signs and ECGs) and tolerability
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Clinical activity and pharmacodynamics
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ayalew Tefferi, MD
Organizational Affiliation
Mayo Clinic, Rochester, MN
Official's Role
Study Chair
Facility Information:
Facility Name
Investigational Site Number 840103
City
La Jolla
State/Province
California
ZIP/Postal Code
92093
Country
United States
Facility Name
Investigational Site Number 840102
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
Facility Name
Investigational Site Number 840105
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Investigational Site Number 840106
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109-0759
Country
United States
Facility Name
Investigational Site Number 840104
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Investigational Site Number 840101
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
12. IPD Sharing Statement
Links:
URL
http://mpdfoundation.org/
Description
MPD Foundation
Learn more about this trial
A Long-Term Study of the Effects of Orally Administered SAR302503 in Patients With Myelofibrosis
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