Status:
COMPLETED
A Dose-escalation Study of the Safety and Tolerability of Orally Administered TG101348 in Patients With Myelofibrosis
Lead Sponsor:
TargeGen
Conditions:
Myelofibrosis
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
The purpose of this study is to evaluate the safety and tolerability of orally administered TG101348 in patients with myelofibrosis.
Detailed Description
TG101348 is a potent small molecule inhibitor of Janus kinase 2 (JAK2). This is a first-in-human study that will include a dose-escalation phase, to establish the maximum tolerated dose, and an expand...
Eligibility Criteria
Inclusion
- Diagnosis of myelofibrosis (primary, post-polycythemia vera, or post-essential thrombocythemia)
- At least 18 years of age.
- ECOG PS 0, 1, or 2.
Exclusion
- 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.
Key Trial Info
Start Date :
January 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2009
Estimated Enrollment :
59 Patients enrolled
Trial Details
Trial ID
NCT00631462
Start Date
January 1 2008
End Date
October 1 2009
Last Update
October 26 2009
Active Locations (6)
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1
UCSD Moores Cancer Center
San Diego, California, United States, 92093
2
Stanford Comprehensive Cancer Center
Stanford, California, United States, 94305
3
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02115
4
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, United States, 48109