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

Myelofibrosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00631462
• Other study ID #: MF-TG101348-001
• Status: Completed
• Phase: Phase 1
• First received: January 29, 2008
• Last updated: October 22, 2009
• Start date: January 2008
• Est. completion date: October 2009

Study information

• Verified date: October 2009
• Source: TargeGen
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 59
• Est. completion date: October 2009
• Est. primary completion date: October 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Myelofibrosis
• Polycythemia Vera
• Primary Myelofibrosis
• Thrombocythemia, Essential

Intervention

Drug:
• TG101348
Orally administered, once a day, for 28 days, up to 6 cycles.

Locations

Country	Name	City	State
United States	University of Michigan Comprehensive Cancer Center	Ann Arbor	Michigan
United States	Dana Farber Cancer Institute	Boston	Massachusetts
United States	MD Anderson Cancer Center	Houston	Texas
United States	Mayo Clinic, Rochester	Rochester	Minnesota
United States	UCSD Moores Cancer Center	San Diego	California
United States	Stanford Comprehensive Cancer Center	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
TargeGen

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety (i.e., adverse events; effects on laboratory parameters, vital signs, and ECGs; dose-limiting toxicities), tolerability, and MTD		28 days	No
Secondary	Pharmacokinetics and pharmacodynamics		28 days	No

External Links

•   MPD Foundation