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

NCT01437787 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 289

Last updated 2025-03-05

No results posted yet for this 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

  • Hematopoietic Neoplasm

Interventions

DRUG

SAR302503

Pharmaceutical form:capsule Route of administration: oral

DRUG

Placebo

Pharmaceutical form:capsule Route of administration: oral

Sponsors & Collaborators

Principal Investigators

  • Clinical Sciences & Operations · Sanofi

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-12-31
Primary Completion
2014-06-30
Completion
2014-06-30

Countries

  • United States
  • Australia
  • Austria
  • Belgium
  • Brazil
  • Canada
  • France
  • Germany
  • Hungary
  • Ireland
  • Israel
  • Italy
  • Lithuania
  • Mexico
  • Poland
  • Portugal
  • Romania
  • Russia
  • Singapore
  • South Africa
  • South Korea
  • Spain
  • Sweden
  • Taiwan
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01437787 on ClinicalTrials.gov