Myelofibrosis
Conditions
Keywords
primary myelofibrosis, post-polycythemia vera myelofibrosis, post-essential thrombocythemia myelofibrosis
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 expanded cohort, dose-confirmation phase. The safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary clinical activity of TG101348 in patients with myelofibrosis will be evaluated.
Interventions
DRUGTG101348
Orally administered, once a day, for 28 days, up to 6 cycles.
Sponsors
TargeGen
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety (i.e., adverse events; effects on laboratory parameters, vital signs, and ECGs; dose-limiting toxicities), tolerability, and MTD | 28 days |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacokinetics and pharmacodynamics | 28 days |
Countries
United States
Outcome results
None listed