MyelofibrosisPhase 1/2NCT00724334
A Long-Term Study of the Effects of Orally Administered SAR302503 in Patients With Myelofibrosis
A Phase 1/2 study testing SAR302503 (TG101348) in people with Myelofibrosis, run by Bristol-Myers Squibb at 6 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myelofibrosis
- What is being tested?
- SAR302503 (TG101348)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 6 sitesUnited States
- Study dates
- 31 Jul 2008to 28 May 2014
- Phase
- Phase 1/2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Completion of MF-TG101348-001 study
- Diagnosis of myelofibrosis
- At least 18 years of age
Who cannot join
- Any acute or chronic medical abnormality that may increase the risk associated with study participation
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Investigational Site Number 840106
Ann Arbor, Michigan, 48109-0759
Investigational Site Number 840105
Boston, Massachusetts, 02115
Investigational Site Number 840101
Houston, Texas, 77030
Investigational Site Number 840103
La Jolla, California, 92093
Investigational Site Number 840104
Rochester, Minnesota, 55905
Investigational Site Number 840102
Stanford, California, 94305
About this study
Official title: 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.
Read the 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.
- Conditions
- Myelofibrosis
- Being tested
- SAR302503 (TG101348)
- Keywords
- myelofibrosis
- Medical subject headings
- Primary Myelofibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SAR302503 (TG101348)Drug
orally administered, once a day
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: SAR302503 (TG101348) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Response (IWG-MRT) - Best Overall Response
Best response categories per IWG-MRT response criteria across studies TED12037 and TED12015 combined. Responses were assessed using IWG-MRT criteria and categorized as complete remission (CR), partial remission (PR), clinical improvement (CI), stable disease (SD), or progressive disease (PD). CR and PR reflect disease modification with resolution or partial resolution of disease features; CI reflects improvement in key clinical parameters without full remission; SD indicates no meaningful change; and PD indicates disease worsening.
Measured: From enrollment to date of first objective response, or death due to any cause (up to approximately 52 months)
Secondary outcomes (4)
Time to Any Response
Time to any first response (CR/PR/CI); median and range. Responses were assessed using IWG-MRT criteria and categorized as complete remission (CR), partial remission (PR), clinical improvement (CI), stable disease (SD), or progressive disease (PD). CR and PR reflect disease modification with resolution or partial resolution of disease features; CI reflects improvement in key clinical parameters without full remission.
Measured: From enrollment to date of first objective response, or death due to any cause (up to approximately 56 months)
Duration of Response
Duration of response (days); range. Responses were assessed using IWG-MRT criteria and categorized as complete remission (CR), partial remission (PR), clinical improvement (CI), stable disease (SD), or progressive disease (PD). CR and PR reflect disease modification with resolution or partial resolution of disease features; CI reflects improvement in key clinical parameters without full remission.
Measured: From enrollmen to death due to any cause (up to approximately 52 months)
Spleen Size at Baseline (TED12037)
Palpable spleen size in cm below the left costal margin at baseline of TED12037.
Measured: Baseline
Transfusion Dependence at Baseline (TED12037)
Transfusion dependence defined as RBC transfusion within 56 days before baseline of TED12037.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2008 (estimated)
- Study start31 Jul 2008
- Primary completion28 May 2014
- Study completion28 May 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for MyelofibrosisStudies of the same condition, open and under way.
- More trials run by Bristol-Myers SquibbThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ayalew Tefferi, MD, Study chair, Mayo Clinic, Rochester, MN
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00724334
- Sponsor's protocol ID
- TED12015
- Other IDs
- MF-TG101348-002
- Status last verified
- Sep 2026
- First submitted
- 17 Jul 2008
- Last updated
- 6 Oct 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No