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

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ClinicalTrials.gov Identifier: NCT00631462
Recruitment Status : Completed
First Posted : March 7, 2008
Last Update Posted : October 26, 2009
Sponsor:
Information provided by:

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  (Clinical Trial)
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 : January 2008
Primary Completion Date : October 2009
Study Completion Date : October 2009


Arms and Interventions

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


Outcome Measures

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

Secondary Outcome Measures :
  1. Pharmacokinetics and pharmacodynamics [ Time Frame: 28 days ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00631462


Locations
United States, California
UCSD Moores Cancer Center
San Diego, California, United States, 92093
Stanford Comprehensive Cancer Center
Stanford, California, United States, 94305
United States, Massachusetts
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02115
United States, Michigan
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, United States, 48109
United States, Minnesota
Mayo Clinic, Rochester
Rochester, Minnesota, United States, 55905
United States, Texas
MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
TargeGen
Investigators
Study Chair: Ayalew Tefferi, MD Mayo Clinic
More Information

Additional Information:
Responsible Party: Jolene Shorr, TargeGen, Inc.
ClinicalTrials.gov Identifier: NCT00631462     History of Changes
Other Study ID Numbers: MF-TG101348-001
First Posted: March 7, 2008    Key Record Dates
Last Update Posted: October 26, 2009
Last Verified: October 2009

Keywords provided by TargeGen:
primary myelofibrosis
post-polycythemia vera myelofibrosis
post-essential thrombocythemia myelofibrosis

Additional relevant MeSH terms:
Primary Myelofibrosis
Polycythemia
Polycythemia Vera
Thrombocythemia, Essential
Myeloproliferative Disorders
Bone Marrow Diseases
Hematologic Diseases
Bone Marrow Neoplasms
Hematologic Neoplasms
Neoplasms by Site
Neoplasms
Blood Coagulation Disorders
Thrombocytosis
Blood Platelet Disorders
Hemorrhagic Disorders