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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

59 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-01-31

Study Completion Date

2009-10-31

Brief Summary

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

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Detailed Description

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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.

Conditions

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Myelofibrosis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Group Type EXPERIMENTAL

TG101348

Intervention Type DRUG

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

Interventions

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TG101348

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

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No