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A Phase 1, Open-label, Dose-escalation Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Orally Administered TG101348 in Patients With Primary, Post-polycythemia Vera, or Post-essential Thrombocythemia Myelofibrosis


Phase 1
18 Years
N/A
Not Enrolling
Both
Myelofibrosis

Thank you

Trial Information

A Phase 1, Open-label, Dose-escalation Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Orally Administered TG101348 in Patients With Primary, Post-polycythemia Vera, or Post-essential Thrombocythemia Myelofibrosis


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.


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.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Safety (i.e., adverse events; effects on laboratory parameters, vital signs, and ECGs; dose-limiting toxicities), tolerability, and MTD

Outcome Time Frame:

28 days

Safety Issue:

No

Principal Investigator

Ayalew Tefferi, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Mayo Clinic

Authority:

United States: Food and Drug Administration

Study ID:

MF-TG101348-001

NCT ID:

NCT00631462

Start Date:

January 2008

Completion Date:

October 2009

Related Keywords:

  • Myelofibrosis
  • primary myelofibrosis
  • post-polycythemia vera myelofibrosis
  • post-essential thrombocythemia myelofibrosis
  • Primary Myelofibrosis
  • Polycythemia
  • Polycythemia Vera
  • Thrombocythemia, Essential
  • Thrombocytosis

Name

Location

MD Anderson Cancer CenterHouston, Texas  77030-4096
University of Michigan Comprehensive Cancer CenterAnn Arbor, Michigan  48109-0752
Dana Farber Cancer InstituteBoston, Massachusetts  02115
UCSD Moores Cancer CenterLa Jolla, California  93093
Mayo Clinic, RochesterRochester, Minnesota  55905
Stanford Comprehensive Cancer CenterStanford, California  94305