A Long-Term Study of the Effects of Orally Administered S... | NCT00724334

Studies
A Long-Term Study of the Effects of Orally Administered SAR302503 in Patients With Myelofibrosis

NCT00724334

Sponsor

Bristol-Myers Squibb

Status

Completed

Last Update Posted

Mar 5, 2025Actual

Enrollment

42Actual

Phase

Phase 1Phase 2

Conditions

Myelofibrosis

Interventions

SAR302503 (TG101348)

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
MF-TG101348-002	Other Identifier	Targegen

Status Module

Record Verification Date

Feb 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2008

Primary Completion Date

May 2014Actual

Completion Date

May 2014Actual

First Submitted Date

Jul 17, 2008

First Submission Date that Met QC Criteria

Jul 25, 2008

First Posted Date

Jul 29, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Feb 17, 2016

Certification/Extension First Submitted that Passed QC Review

Feb 17, 2016

Certification/Extension First Posted Date

Mar 17, 2016Estimated

Last Update Submitted Date

Mar 3, 2025

Last Update Posted Date

Mar 5, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

SAR302503 (TG101348) is a potent small molecule inhibitor of Janus kinase 2 (JAK2). This is an extension study for a first-in-man, dose escalation study (MF-TG101348-001). The safety, tolerability and clinical activity of SAR302503 (TG101348) in subjects with myelofibrosis will be evaluated.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

42Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental		Drug: SAR302503 (TG101348)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
SAR302503 (TG101348)	Drug	orally administered, once a day	1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Safety (i.e. adverse events, effects on laboratory parameters, vital signs and ECGs) and tolerability		6 months

Secondary Outcomes

Measure	Description	Time Frame
Clinical activity and pharmacodynamics		6 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Ayalew Tefferi, MD	Mayo Clinic, Rochester, MN	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Investigational Site Number 840103		La Jolla	California	92093	United States
Investigational Site Number 840102

Label	URL
MPD Foundation	View source

Condition Browse Module

MeSH Terms

ID	Term
D055728	Primary Myelofibrosis

Ancestor Terms

ID	Term
D009196	Myeloproliferative Disorders
D001855	Bone Marrow Diseases
D006402	Hematologic Diseases
D006425	Hemic and Lymphatic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C528327	fedratinib

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided