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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00631462
First Posted: March 7, 2008
Last Update Posted: October 26, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
TargeGen
January 29, 2008
March 7, 2008
October 26, 2009
January 2008
October 2009   (Final data collection date for primary outcome measure)
Safety (i.e., adverse events; effects on laboratory parameters, vital signs, and ECGs; dose-limiting toxicities), tolerability, and MTD [ Time Frame: 28 days ]
Safety, tolerability, and MTD [ Time Frame: 28 days ]
Complete list of historical versions of study NCT00631462 on ClinicalTrials.gov Archive Site
Pharmacokinetics and pharmacodynamics [ Time Frame: 28 days ]
Same as current
Not Provided
Not Provided
 
A Dose-escalation Study of the Safety and Tolerability of Orally Administered TG101348 in Patients With Myelofibrosis
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
The purpose of this study is to evaluate the safety and tolerability of orally administered TG101348 in patients with 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.
Interventional
Phase 1
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Myelofibrosis
Drug: TG101348
Orally administered, once a day, for 28 days, up to 6 cycles.
Experimental: 1
Intervention: Drug: TG101348
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
59
October 2009
October 2009   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00631462
MF-TG101348-001
No
Not Provided
Not Provided
Jolene Shorr, TargeGen, Inc.
TargeGen
Not Provided
Study Chair: Ayalew Tefferi, MD Mayo Clinic
TargeGen
October 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP