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NCT01523171 · ClinicalTrials.gov registry record · Phase 2
Phase II, Open Label, Single Arm Study of SAR302503 In Myelofibrosis Patients Previously Treated With Ruxolitinib
A Phase 2 study, sponsored by Bristol-Myers Squibb.
- Completed
- Registry status
- Phase 2
- Development phase
- 97
- Enrollment target
NCT01523171: Completed Phase 2 study, sponsored by Bristol-Myers Squibb.
NCT01523171 is a Phase 2 study that has completed, run by Bristol-Myers Squibb. The registered enrollment target is 97 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (27% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01523171, a Phase 2 study, has completed, sponsored by Bristol-Myers Squibb.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 97 participants
- Enrollment target
Study Summary
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
Primary Outcome
Spleen volume was measured by central imaging MRI (CT scan in participants with contraindications for MRI). Analysis was performed on Per Protocol (PP) population defined as all treated participants with a baseline and at least one post-baseline MRI/CT scan of spleen volume, and had no important protocol deviations that could impact on efficacy outcome. Last observation carried forward (LOCF) method was used to impute the missing data.
Interventions
- DRUG SAR302503
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 97 participants |
| Start Date | 2012-04 |
| Est. Completion | 2014-04 |
| Phase | Phase 2 |
What the finished NCT01523171 record still lists
NCT01523171 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 97 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (27% lower).
The record links to 0 conditions, and to 1 intervention - of which SAR302503 is the first listed.
NCT01523171 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01523171 about?
NCT01523171 is a clinical study titled "Phase II, Open Label, Single Arm Study of SAR302503 In Myelofibrosis Patients Previously Treated With Ruxolitinib". 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...
What is the current status of trial NCT01523171?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 97 participants. The study started on 2012-04. Estimated completion is 2014-04.
What interventions are being tested in trial NCT01523171?
The interventions under investigation include: SAR302503 (DRUG).
Who is sponsoring clinical trial NCT01523171?
This trial is sponsored by Bristol-Myers Squibb, which has 1,025 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01523171's enrollment target sits among peer trials
97 746th of 2000 higher than 1,254 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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