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Phase 2 Study of SAR302503 in Patients With Myelofibrosis
NCT01420770 · View on ClinicalTrials.gov ↗
Study Summary
Primary Objective: \- To evaluate the efficacy of daily oral doses of 300 mg, 400 mg, and 500 mg SAR302503 for the reduction of spleen volume as determined by magnetic resonance imaging (MRI). Secondary Objectives: * To evaluate the safety of SAR302503. * To evaluate the pharmacokinetics (PK) of SAR302503 after single and repeat doses. * To evaluate the pharmacodynamics of SAR302503 as measured by changes in JAK2V617F allele burden in those patients with JAK2V617F mutation, changes in substrate phosphorylation in the JAK-STAT signal transduction pathway, and the expression of cytokines. * To measure improvement in baseline Myeloproliferative Neoplasm (MPN) associated symptoms, as well as overall impact in quality of life (QOL), through serial administration of the Myeloproliferative Neoplasm Symptom Assessment Form (MPN-SAF). * To measure generic health-related quality of life (HRQL) and utility values using the EQ-5D questionnaire.
Conditions Studied
Interventions
- DRUG SAR302503
Study Locations (4)
California
- Investigational Site Number 840001 — San Francisco
Michigan
- Investigational Site Number 840003 — Ann Arbor
Minnesota
- Investigational Site Number 840006 — Rochester
Ohio
- Investigational Site Number 840007 — Canton
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2011-08 |
| Est. Completion | 2014-04 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01420770
The ClinicalTrials.gov registry entry for NCT01420770 describes a study currently listed as completed. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Bristol-Myers Squibb, which has 504 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Hematopoietic Neoplasm appearing as the primary indexed condition, and to 1 intervention — of which SAR302503 is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT01420770 reports 4 study locations spanning 4 distinct geographic areas — top geographies include California, Michigan, Minnesota. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT01420770 about?
NCT01420770 is a clinical study titled "Phase 2 Study of SAR302503 in Patients With Myelofibrosis". Primary Objective: \- To evaluate the efficacy of daily oral doses of 300 mg, 400 mg, and 500 mg SAR302503 for the reduction of spleen volume as determined by magnetic resonance imaging (MRI). Secondary Objectives: * To evaluate the safety of SAR302503. * To evaluate the pharmacokinetics (PK) of ...
What is the current status of trial NCT01420770?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 30 participants. The study started on 2011-08. Estimated completion is 2014-04.
What conditions does trial NCT01420770 study?
This clinical trial studies the following conditions: Hematopoietic Neoplasm. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT01420770?
The interventions under investigation include: SAR302503 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT01420770?
This trial is sponsored by Bristol-Myers Squibb, which has 504 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT01420770 being conducted?
This trial has 4 study locations across California, Michigan, Minnesota, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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