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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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
Are there results?: Yes, posted in the registrySummary in the doctors' view

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.

City, postcode or hospital

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

Other trials in United States

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 groups in NCT00724334
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.

31 Jul 200828 May 2014

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)

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

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 1/2
Treating Anemia in Myelofibrosis With Repurposed Drugs (Nelfinavir) That Restore Iron Delivery to the Bone Marrow
Myelofibrosis, Myelofibrosis; Anemia
RecruitingPhase 3
A Phase 3 Study of Pelabresib (DAK539) and Ruxolitinib in Myelofibrosis (MF)
Primary Myelofibrosis (PMF), Post-polycythemia Vera Myelofibrosis (PPV-MF)
RecruitingPhase 2
CMV-MVA Triplex Vaccination in HLA-Matched Related Stem Cell Donors for the Prevention of CMV Infection in Patients Undergoing Hematopoietic Stem Cell Transplant
Acute Lymphoblastic Leukemia, Acute Myeloid Leukemia
RecruitingPhase 1
A Vaccine (CMV-MVA Triplex Vaccine) for the Enhancement of CMV-Specific Immunity and the Prevention of CMV Viremia in Patients Undergoing Haploidentical Hematopoietic Stem Cell Transplant
Accelerated Phase Chronic Myeloid Leukemia, BCR-ABL1 Positive, Acute Lymphoblastic Leukemia
Active, not recruitingObservational study
Infection Prophylaxis and Management in Treating Cytomegalovirus (CMV) Infection in Patients With Hematologic Malignancies Previously Treated With Donor Stem Cell Transplant
Hematopoietic/Lymphoid Cancer, Accelerated Phase Chronic Myelogenous Leukemia

All Myelofibrosis trials

Study at a glance

From the registry record, last updated by the sponsor on 6 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open-Label Study to Evaluate the Long-Term Effects of Orally Administered SAR302503 in Patients With Primary or Secondary Myelofibrosis
ClinicalTrials.gov ID: NCT00724334
Acronym / sponsor ID: TED12015
Conditions: Myelofibrosis
Keywords: myelofibrosis
Phase: Phase 1/2
Study type: Interventional
Recruitment status: Completed
Enrolment: 43 participants (actual)
Lead sponsor: Bristol-Myers SquibbIndustry (pharma, biotech, devices)
Study start: 31 Jul 2008 (actual)
Primary completion: 28 May 2014 (actual)
Study completion: 28 May 2014 (actual)
First posted: 29 Jul 2008 (estimated)
Results: Posted 6 Oct 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
1	Experimental	Drug: SAR302503 (TG101348)

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Completion of MF-TG101348-001 study
Diagnosis of myelofibrosis
At least 18 years of age

Key exclusion criteria (1 listed)

Any acute or chronic medical abnormality that may increase the risk associated with study participation

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
SAR302503 (TG101348)orally administered, once a day	Drug	1

Primary outcome

Clinical Response (IWG-MRT) - Best Overall Response
Time frame: From enrollment to date of first objective response, or death due to any cause (up to approximately 52 months)
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.

4 secondary outcomes

Time to Any Response
Time frame: From enrollment to date of first objective response, or death due to any cause (up to approximately 56 months)
Duration of Response
Time frame: From enrollmen to death due to any cause (up to approximately 52 months)
Spleen Size at Baseline (TED12037)
Time frame: Baseline
Transfusion Dependence at Baseline (TED12037)
Time frame: Baseline

Results and safety

Results posted to the registry on 6 Oct 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
SAR302503	43	12

Primary outcome: Clinical Response (IWG-MRT) - Best Overall Response

Time frame: From enrollment to date of first objective response, or death due to any cause (up to approximately 52 months). Count of participants. Unit: Participants

Measure	SAR302503 n = 43
Complete Remission (CR)	1
Partial Remission (PR)	0
Clinical Improvement (CI)	31
Stable Disease	11
Progressive Disease	0

Population analysed: All treated participants.

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: AEs/SAEs are collected from the first dose date until the last dose date + 30 days (up to approximately 55 months). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
SAR302503	23 of 43 (53.5%)	43 of 43 (100%)	8 of 43

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
MPD FoundationLink provided by the sponsor.

Related trials for Myelofibrosis

RecruitingPhase 1/2
Treating Anemia in Myelofibrosis With Repurposed Drugs (Nelfinavir) That Restore Iron Delivery to the Bone Marrow
Myelofibrosis, Myelofibrosis; Anemia
RecruitingPhase 3
A Phase 3 Study of Pelabresib (DAK539) and Ruxolitinib in Myelofibrosis (MF)
Primary Myelofibrosis (PMF), Post-polycythemia Vera Myelofibrosis (PPV-MF)
RecruitingPhase 2
CMV-MVA Triplex Vaccination in HLA-Matched Related Stem Cell Donors for the Prevention of CMV Infection in Patients Undergoing Hematopoietic Stem Cell Transplant
Acute Lymphoblastic Leukemia, Acute Myeloid Leukemia
RecruitingPhase 1
A Vaccine (CMV-MVA Triplex Vaccine) for the Enhancement of CMV-Specific Immunity and the Prevention of CMV Viremia in Patients Undergoing Haploidentical Hematopoietic Stem Cell Transplant
Accelerated Phase Chronic Myeloid Leukemia, BCR-ABL1 Positive, Acute Lymphoblastic Leukemia
Active, not recruitingObservational study
Infection Prophylaxis and Management in Treating Cytomegalovirus (CMV) Infection in Patients With Hematologic Malignancies Previously Treated With Donor Stem Cell Transplant
Hematopoietic/Lymphoid Cancer, Accelerated Phase Chronic Myelogenous Leukemia

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Ayalew Tefferi, MD study chair

Mayo Clinic, Rochester, MN

6 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing SAR302503 (TG101348) in people with Myelofibrosis, run by Bristol-Myers Squibb at 6 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 6 Oct 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Clinical Response (IWG-MRT) - Best Overall Response (time frame: From enrollment to date of first objective response, or death due to any cause (up to approximately 52 months)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00724334.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2026; AzTrials last refreshed its copy on 26 Oct 2026.