NCT00724334

Brief Summary

The purpose of this study is to evaluate the long-term effects of orally administered SAR302503 (TG101348) in patients with myelofibrosis who have completed the MF-TG101348-001 study.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Jul 2008

Longer than P75 for phase_1

Geographic Reach
1 country

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2008

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

July 17, 2008

Completed
12 days until next milestone

First Posted

Study publicly available on registry

July 29, 2008

Completed
5.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2014

Completed
Last Updated

March 5, 2025

Status Verified

February 1, 2016

Enrollment Period

5.8 years

First QC Date

July 17, 2008

Last Update Submit

March 3, 2025

Conditions

Myelofibrosis

Keywords

myelofibrosis

Outcome Measures

Primary Outcomes (1)

  • Safety (i.e. adverse events, effects on laboratory parameters, vital signs and ECGs) and tolerability

    6 months

Secondary Outcomes (1)

  • Clinical activity and pharmacodynamics

    6 months

Study Arms (1)

1

EXPERIMENTAL
Drug: SAR302503 (TG101348)

Interventions

SAR302503 (TG101348)DRUG

orally administered, once a day

1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Completion of MF-TG101348-001 study
  • Diagnosis of myelofibrosis
  • At least 18 years of age

You may not qualify if:

  • Any acute or chronic medical abnormality that may increase the risk associated with study participation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Investigational Site Number 840103

La Jolla, California, 92093, United States

Location

Investigational Site Number 840102

Stanford, California, 94305, United States

Location

Investigational Site Number 840105

Boston, Massachusetts, 02115, United States

Location

Investigational Site Number 840106

Ann Arbor, Michigan, 48109-0759, United States

Location

Investigational Site Number 840104

Rochester, Minnesota, 55905, United States

Location

Investigational Site Number 840101

Houston, Texas, 77030, United States

Location

Related Links

MeSH Terms

Conditions

Primary Myelofibrosis

Interventions

fedratinib

Condition Hierarchy (Ancestors)

Myeloproliferative DisordersBone Marrow DiseasesHematologic DiseasesHemic and Lymphatic Diseases

Study Officials

  • Ayalew Tefferi, MD

    Mayo Clinic, Rochester, MN

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 17, 2008

First Posted

July 29, 2008

Study Start

July 1, 2008

Primary Completion

May 1, 2014

Study Completion

May 1, 2014

Last Updated

March 5, 2025

Record last verified: 2016-02

Locations

US(6)