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COMPLETED Phase 3

Phase III Study of SAR302503 in Intermediate-2 and High Risk Patients With Myelofibrosis

NCT01437787 · View on ClinicalTrials.gov ↗

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

FieldValue
Enrollment Target 289 participants
Start Date 2011-12
Est. Completion 2014-06
Phase Phase 3

Sponsor

Bristol-Myers Squibb

504 total trials

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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. It is categorized as Phase 3, 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 289 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 2 interventions — of which Placebo 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: NCT01437787 reports 20 study locations spanning 8 distinct geographic areas — top geographies include Other, California, Arizona. 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 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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT01437787?

The interventions under investigation include: Placebo (DRUG), SAR302503 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT01437787?

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 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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial