A Long-Term Study of the Effects of Orally Administered SAR302503 in Patients With Myelofibrosis
Sponsor
Sanofi (Industry)
Overall Status
Completed
CT.gov ID
NCT00724334
Collaborator
(none)
42
6
1
70
7
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Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1/Phase 2 |
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 Design
Study Type:
Interventional
Actual Enrollment
:
42 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
An Open-Label Study to Evaluate the Long-Term Effects of Orally Administered SAR302503 in Patients With Primary or Secondary Myelofibrosis
Study Start Date
:
Jul 1, 2008
Actual Primary Completion Date
:
May 1, 2014
Actual Study Completion Date
:
May 1, 2014
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 1
|
Drug: SAR302503 (TG101348)
orally administered, once a day
|
Outcome Measures
Primary Outcome Measures
- Safety (i.e. adverse events, effects on laboratory parameters, vital signs and ECGs) and tolerability [6 months]
Secondary Outcome Measures
- Clinical activity and pharmacodynamics [6 months]
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Investigational Site Number 840103 | La Jolla | California | United States | 92093 |
| 2 | Investigational Site Number 840102 | Stanford | California | United States | 94305 |
| 3 | Investigational Site Number 840105 | Boston | Massachusetts | United States | 02115 |
| 4 | Investigational Site Number 840106 | Ann Arbor | Michigan | United States | 48109-0759 |
| 5 | Investigational Site Number 840104 | Rochester | Minnesota | United States | 55905 |
| 6 | Investigational Site Number 840101 | Houston | Texas | United States | 77030 |
Sponsors and Collaborators
- Sanofi
Investigators
- Study Chair: Ayalew Tefferi, MD, Mayo Clinic, Rochester, MN
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.Responsible Party:
Sanofi
ClinicalTrials.gov Identifier:
NCT00724334
Other Study ID Numbers:
- TED12015
- MF-TG101348-002
First Posted:
Jul 29, 2008
Last Update Posted:
Mar 17, 2016
Last Verified:
Feb 1, 2016