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

Sponsor

TargeGen (Industry)

Overall Status

Completed

CT.gov ID

NCT00631462

Collaborator

(none)

Enrollment

Locations

Arm

Duration (Months)

9.8

Patients Per Site

0.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Myelofibrosis	Drug: TG101348	Phase 1

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 Design

Study Type:

Interventional

Actual Enrollment :

59 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Study Start Date :

Jan 1, 2008

Actual Primary Completion Date :

Oct 1, 2009

Actual Study Completion Date :

Oct 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1	Drug: TG101348 Orally administered, once a day, for 28 days, up to 6 cycles.

Arm

Intervention/Treatment

Experimental: 1

Drug: TG101348

Orally administered, once a day, for 28 days, up to 6 cycles.

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

Pharmacokinetics and pharmacodynamics [28 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	UCSD Moores Cancer Center	San Diego	California	United States	92093
2	Stanford Comprehensive Cancer Center	Stanford	California	United States	94305
3	Dana Farber Cancer Institute	Boston	Massachusetts	United States	02115
4	University of Michigan Comprehensive Cancer Center	Ann Arbor	Michigan	United States	48109
5	Mayo Clinic, Rochester	Rochester	Minnesota	United States	55905
6	MD Anderson Cancer Center	Houston	Texas	United States	77030