NCT00631462

Brief Summary

The purpose of this study is to evaluate the safety and tolerability of orally administered TG101348 in patients with myelofibrosis.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
59

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Jan 2008

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

January 1, 2008

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

January 29, 2008

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 7, 2008

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2009

Completed
Last Updated

October 26, 2009

Status Verified

October 1, 2009

Enrollment Period

1.8 years

First QC Date

January 29, 2008

Last Update Submit

October 22, 2009

Conditions

Myelofibrosis

Keywords

primary myelofibrosispost-polycythemia vera myelofibrosispost-essential thrombocythemia myelofibrosis

Outcome Measures

Primary Outcomes (1)

  • Safety (i.e., adverse events; effects on laboratory parameters, vital signs, and ECGs; dose-limiting toxicities), tolerability, and MTD

    28 days

Secondary Outcomes (1)

  • Pharmacokinetics and pharmacodynamics

    28 days

Study Arms (1)

1

EXPERIMENTAL
Drug: TG101348

Interventions

TG101348DRUG

Orally administered, once a day, for 28 days, up to 6 cycles.

1

Eligibility Criteria

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

You may qualify if:

  • Diagnosis of myelofibrosis (primary, post-polycythemia vera, or post-essential thrombocythemia)
  • At least 18 years of age.
  • ECOG PS 0, 1, or 2.

You may not qualify if:

  • Any chemotherapy, immunomodulatory therapy, immunosuppressive therapy, corticosteroids, or growth factor treatment within 14 days prior to initiation of study drug.
  • Major surgery or radiation therapy within 28 days prior to initiation of study drug.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

UCSD Moores Cancer Center

San Diego, California, 92093, United States

Location

Stanford Comprehensive Cancer Center

Stanford, California, 94305, United States

Location

Dana Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

University of Michigan Comprehensive Cancer Center

Ann Arbor, Michigan, 48109, United States

Location

Mayo Clinic, Rochester

Rochester, Minnesota, 55905, United States

Location

MD Anderson Cancer Center

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

    STUDY CHAIR

Study Design

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

Study Record Dates

First Submitted

January 29, 2008

First Posted

March 7, 2008

Study Start

January 1, 2008

Primary Completion

October 1, 2009

Study Completion

October 1, 2009

Last Updated

October 26, 2009

Record last verified: 2009-10

Locations

US(6)