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

TargeGen

Status and phase

Completed

Phase 1

Conditions

Myelofibrosis

Treatments

Drug: TG101348

Study type

Interventional

Funder types

Industry

Identifiers

NCT00631462

MF-TG101348-001

Details and patient eligibility

About

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

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.

Enrollment

59 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.