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NCT01420770 · ClinicalTrials.gov registry record · Phase 2
Phase 2 Study of SAR302503 in Patients With Myelofibrosis
A Phase 2 study of Hematopoietic Neoplasm, sponsored by Bristol-Myers Squibb.
- Completed
- Registry status
- Phase 2
- Development phase
- 30
- Enrollment target
- 4
- Study locations
NCT01420770 is a Phase 2 study of Hematopoietic Neoplasm that has completed, run by Bristol-Myers Squibb. The registered enrollment target is 30 participants, below the 188-participant average among 3 other Hematopoietic Neoplasm trials with a reported enrollment target (84% lower). The trial reports 4 study locations across 4 states.
The verdict
NCT01420770, a Phase 2 study of Hematopoietic Neoplasm, has completed, sponsored by Bristol-Myers Squibb.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 30 participants
- Enrollment target
- 4
- Study locations
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 |
Interested in This Trial?
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, categorized as Phase 2. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 188-participant average among 3 other Hematopoietic Neoplasm trials with a reported enrollment target (84% lower). 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 1 intervention - of which SAR302503 is the first listed.
NCT01420770 reports 4 study locations spanning 4 distinct geographic areas - top geographies include California, Michigan, Minnesota.
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.
What interventions are being tested in trial NCT01420770?
The interventions under investigation include: SAR302503 (DRUG).
Who is sponsoring clinical trial NCT01420770?
This trial is sponsored by Bristol-Myers Squibb, which has 1,025 total clinical trials registered on ClinicalTrials.gov.
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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