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

Phase 1

Completed

• Conditions: Myelofibrosis
• Interventions: Drug: TG101348

• Registration Number: NCT00631462
• Lead Sponsor: TargeGen

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.

Study Timeline

• Study Start: 2008-01
• Study First Submitted: 2008-01-29
• Study First Submitted QC: 2008-03-06
• Study First Posted: 2008-03-07
• Status Verified: 2009-10
• Primary Completion: 2009-10
• Study Completion: 2009-10
• Last Update Submitted: 2009-10-22
• Last Update Posted: 2009-10-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 59

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	TG101348	-

Primary Outcome Measures

Name	Time	Method
Safety (i.e., adverse events; effects on laboratory parameters, vital signs, and ECGs; dose-limiting toxicities), tolerability, and MTD	28 days

Secondary Outcome Measures

Name	Time	Method
Pharmacokinetics and pharmacodynamics	28 days

Trial Locations

Locations (6)

Dana Farber Cancer Institute; 🇺🇸 Boston, Massachusetts, United States

University of Michigan Comprehensive Cancer Center; 🇺🇸 Ann Arbor, Michigan, United States

MD Anderson Cancer Center; 🇺🇸 Houston, Texas, United States

UCSD Moores Cancer Center; 🇺🇸 San Diego, California, United States

Stanford Comprehensive Cancer Center; 🇺🇸 Stanford, California, United States

Mayo Clinic, Rochester; 🇺🇸 Rochester, Minnesota, United States