Myeloproliferative Neoplasms Clinical Trial

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A Dose-escalation Study of the Safety and Tolerability of Orally Administered TG101348 in Patients With Myelofibrosis

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Summary

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

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Full 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 expanded cohort, dose-confirmation phase. The safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary clinical activity of TG101348 in patients with myelofibrosis will be evaluated.

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Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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.

Study is for people with:

Myeloproliferative Neoplasms

Phase:

Phase 1

Estimated Enrollment:

59

Study ID:

NCT00631462

Recruitment Status:

Completed

Sponsor:

TargeGen

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There are 6 Locations for this study

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UCSD Moores Cancer Center
San Diego California, 92093, United States
Stanford Comprehensive Cancer Center
Stanford California, 94305, United States
Dana Farber Cancer Institute
Boston Massachusetts, 02115, United States
University of Michigan Comprehensive Cancer Center
Ann Arbor Michigan, 48109, United States
Mayo Clinic, Rochester
Rochester Minnesota, 55905, United States
MD Anderson Cancer Center
Houston Texas, 77030, United States
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How clear is this clinincal trial information?

Study is for people with:

Myeloproliferative Neoplasms

Phase:

Phase 1

Estimated Enrollment:

59

Study ID:

NCT00631462

Recruitment Status:

Completed

Sponsor:


TargeGen

How clear is this clinincal trial information?

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