Phase II, Open Label, Single Arm Study of SAR302503 In Myelofibrosis Patients Previously Treated With Ruxolitinib
Public ClinicalTrials.gov record NCT01523171. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase II, Multicenter, Open Label, Single Arm Study of SAR302503 in Subjects Previously Treated With Ruxolitinib and With a Current Diagnosis of Intermediate or High-Risk Primary Myelofibrosis, Post-Polycythemia Vera Myelofibrosis, or Post-Essential Thrombocythemia Myelofibrosis
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
Primary Objective: \- To evaluate the efficacy of once daily dose of SAR302503 in subjects previously treated with ruxolitinib and with a current diagnosis of intermediate-1 with symptoms, Intermediate-2 or high-risk primary myelofibrosis (PMF), post-polycythemia vera myelofibrosis (Post-PV MF), or post-essential thrombocythemia myelofibrosis (Post-ET MF) based on the reduction of spleen volume at the end of 6 treatment cycles; Secondary Objectives: * To evaluate the effect of SAR302503 on Myelofibrosis (MF) associated symptoms as measured by the modified Myelofibrosis Symptom Assessment Form (MFSAF) diary * To evaluate the durability of splenic response * To evaluate the splenic response to SAR302503 by palpation at the end of Cycle 6 * To evaluate the splenic response to SAR302503 at the end of Cycle 3 * To evaluate the effect of SAR302503 on the Janus kinase 2 (JAK2) V617F allele burden * To evaluate the safety and tolerability of SAR302503 in this population * To evaluate plasma concentrations of SAR302503 for population PK analysis, if warranted
Study identification
- NCT ID
- NCT01523171
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 97 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Apr 29, 2012
- Primary completion
- Apr 29, 2014
- Completion
- Apr 29, 2014
- Last update posted
- Jul 15, 2026
2012 – 2014
United States locations
- U.S. sites
- 16
- U.S. states
- 12
- U.S. cities
- 13
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Investigational Site Number 840007 | Phoenix | Arizona | 85054 | — |
| Investigational Site Number 840003 | San Francisco | California | 94143 | — |
| Investigational Site Number 840004 | San Francisco | California | 94143 | — |
| Investigational Site Number 840005 | Atlanta | Georgia | 30322 | — |
| Investigational Site Number 840014 | Chicago | Illinois | 60637 | — |
| Investigational Site Number 840001 | Kansas City | Kansas | 66160-7321 | — |
| Investigational Site Number 840017 | Baltimore | Maryland | 21201 | — |
| Investigational Site Number 840013 | Baltimore | Maryland | 21229 | — |
| Investigational Site Number 840010 | Ann Arbor | Michigan | 48109-0759 | — |
| Investigational Site Number 840009 | New York | New York | 10021 | — |
| Investigational Site Number 840018 | New York | New York | 10032 | — |
| Investigational Site Number 840022 | Cleveland | Ohio | 44195 | — |
| Investigational Site Number 840019 | Middletown | Ohio | 45042 | — |
| Investigational Site Number 840024 | Charleston | South Carolina | 29406 | — |
| Investigational Site Number 840002 | Houston | Texas | 77030 | — |
| Investigational Site Number 840015 | Salt Lake City | Utah | 84112-5550 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 26 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01523171, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jul 15, 2026 · Synced Sep 2, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT01523171 live on ClinicalTrials.gov.