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NCT01437787 · ClinicalTrials.gov registry record · Phase 3
Phase III Study of SAR302503 in Intermediate-2 and High Risk Patients With Myelofibrosis
A Phase 3 study of Hematopoietic Neoplasm, sponsored by Bristol-Myers Squibb.
- Completed
- Registry status
- Phase 3
- Development phase
- 289
- Enrollment target
- 20
- Study locations
NCT01437787 is a Phase 3 study of Hematopoietic Neoplasm that has completed, run by Bristol-Myers Squibb. The registered enrollment target is 289 participants, above the 102-participant average among 3 other Hematopoietic Neoplasm trials with a reported enrollment target (183% higher). The trial reports 20 study locations across 8 states.
The verdict
NCT01437787, a Phase 3 study of Hematopoietic Neoplasm, has completed, sponsored by Bristol-Myers Squibb.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 289 participants
- Enrollment target
- 20
- Study locations
Study Summary
Primary Objective: * To evaluate the efficacy of daily oral doses of 400 mg or 500 mg of SAR302503 (Investigational Medicinal Product, IMP) compared to placebo in the reduction of spleen volume as determined by magnetic resonance imaging (MRI) (or computed tomography scan in patients with contraindications for MRI). Secondary Objectives: * To evaluate the effect on Myelofibrosis (MF)-associated symptoms (key MF symptoms) as measured by the modified Myelofibrosis Symptom Assessment Form (MFSAF) diary. * To evaluate the Overall Survival of patients treated with either 400 mg/day or 500 mg/day of IMP as compared to placebo. * To evaluate the Progression Free Survival of patients treated with either 400 mg/day or 500 mg/day of IMP as compared to placebo. * To evaluate the durability of splenic response. * To evaluate the safety of IMP.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG SAR302503
Study Locations (20)
Other
- Investigational Site Number 036001 - Box Hill
- Investigational Site Number 036005 - Herston
- Investigational Site Number 036003 - Randwick
- Investigational Site Number 036004 - Tweed Heads
- Investigational Site Number 036002 - Wodonga
- Investigational Site Number 040001 - Vienna
- Investigational Site Number 056003 - Antwerp
- Investigational Site Number 056001 - Leuven
- Investigational Site Number 076002 - Jaú
- Investigational Site Number 076004 - Porto Alegre
- Investigational Site Number 076001 - Rio de Janeiro
California
- Investigational Site Number 840001 - La Jolla
- Investigational Site Number 840012 - La Jolla
- Investigational Site Number 840006 - Los Angeles
Arizona
- Investigational Site Number 840014 - Scottsdale
Louisiana
- Investigational Site Number 840013 - Baton Rouge
Minnesota
- Investigational Site Number 840008 - Rochester
New Jersey
- Investigational Site Number 840009 - Newark
Ohio
- Investigational Site Number 840002 - Canton
Texas
- Investigational Site Number 840004 - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 289 participants |
| Start Date | 2011-12 |
| Est. Completion | 2014-06 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01437787
The ClinicalTrials.gov registry entry for NCT01437787 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 289 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 102-participant average among 3 other Hematopoietic Neoplasm trials with a reported enrollment target (183% higher). The listed sponsor is Bristol-Myers Squibb, which has 1,025 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Hematopoietic Neoplasm appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT01437787 reports 20 study locations spanning 8 distinct geographic areas - top geographies include Other, California, Arizona.
Frequently Asked Questions
What is clinical trial NCT01437787 about?
NCT01437787 is a clinical study titled "Phase III Study of SAR302503 in Intermediate-2 and High Risk Patients With Myelofibrosis". Primary Objective: * To evaluate the efficacy of daily oral doses of 400 mg or 500 mg of SAR302503 (Investigational Medicinal Product, IMP) compared to placebo in the reduction of spleen volume as determined by magnetic resonance imaging (MRI) (or computed tomography scan in patients with contraind...
What is the current status of trial NCT01437787?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 289 participants. The study started on 2011-12. Estimated completion is 2014-06.
What conditions does trial NCT01437787 study?
This clinical trial studies the following conditions: Hematopoietic Neoplasm.
What interventions are being tested in trial NCT01437787?
The interventions under investigation include: Placebo (DRUG), SAR302503 (DRUG).
Who is sponsoring clinical trial NCT01437787?
This trial is sponsored by Bristol-Myers Squibb, which has 1,025 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01437787 being conducted?
This trial has 20 study locations across Arizona, California, Louisiana, Minnesota, New Jersey. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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