A Long-Term Study of the Effects of Orally Administered SAR302503 in Patients With Myelofibrosis
This study is ongoing, but not recruiting participants.
Sponsor:
Sanofi
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT00724334
First received: July 17, 2008
Last updated: February 12, 2013
Last verified: February 2013
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Myelofibrosis |
Drug: SAR302503 (TG101348) |
Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: 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 |
Resource links provided by NLM:
Further study details as provided by Sanofi:
Primary Outcome Measures:
- Safety (i.e. adverse events, effects on laboratory parameters, vital signs and ECGs) and tolerability [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Clinical activity and pharmacodynamics [ Time Frame: 6 months ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 60 |
| Study Start Date: | July 2008 |
| Estimated Study Completion Date: | December 2013 |
| Estimated Primary Completion Date: | December 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 |
Drug: SAR302503 (TG101348)
orally administered, once a day
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00724334
Locations
| United States, California | |
| UCSD Moores Cancer Center | |
| San Diego, California, United States, 92093 | |
| Stanford Comprehensive Cancer Center | |
| Stanford, California, United States, 94305 | |
| United States, Massachusetts | |
| Dana Farber Cancer Institute | |
| Boston, Massachusetts, United States, 02115 | |
| United States, Michigan | |
| University of Michigan Comprehensive Cancer Center | |
| Ann Arbor, Michigan, United States, 48109 | |
| United States, Minnesota | |
| Mayo Clinic, Rochester | |
| Rochester, Minnesota, United States, 55905 | |
| United States, Texas | |
| MD Anderson Cancer Center | |
| Houston, Texas, United States, 77030 | |
Sponsors and Collaborators
Sanofi
Investigators
| Study Chair: | Ayalew Tefferi, MD | Mayo Clinic, Rochester, MN |
More Information
Additional Information:
No publications provided
| Responsible Party: | Sanofi |
| ClinicalTrials.gov Identifier: | NCT00724334 History of Changes |
| Other Study ID Numbers: | TED12015, MF-TG101348-002 |
| Study First Received: | July 17, 2008 |
| Last Updated: | February 12, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Sanofi:
|
myelofibrosis |
Additional relevant MeSH terms:
|
Primary Myelofibrosis Myeloproliferative Disorders Bone Marrow Diseases Hematologic Diseases |
ClinicalTrials.gov processed this record on June 17, 2013