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

This study has been completed.
Sponsor:
Information provided by:
TargeGen
ClinicalTrials.gov Identifier:
NCT00631462
First received: January 29, 2008
Last updated: October 22, 2009
Last verified: October 2009
  Purpose

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


Condition Intervention Phase
Myelofibrosis
Drug: TG101348
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by TargeGen:

Primary Outcome Measures:
  • Safety (i.e., adverse events; effects on laboratory parameters, vital signs, and ECGs; dose-limiting toxicities), tolerability, and MTD [ Time Frame: 28 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Pharmacokinetics and pharmacodynamics [ Time Frame: 28 days ] [ Designated as safety issue: No ]

Enrollment: 59
Study Start Date: January 2008
Study Completion Date: October 2009
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: TG101348
Orally administered, once a day, for 28 days, up to 6 cycles.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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:
No publications provided

Responsible Party: Jolene Shorr, TargeGen, Inc.
ClinicalTrials.gov Identifier: NCT00631462     History of Changes
Other Study ID Numbers: MF-TG101348-001
Study First Received: January 29, 2008
Last Updated: October 22, 2009
Health Authority: United States: Food and Drug Administration

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
Thrombocytosis
Myeloproliferative Disorders
Bone Marrow Diseases
Hematologic Diseases
Blood Coagulation Disorders
Blood Platelet Disorders
Hemorrhagic Disorders

ClinicalTrials.gov processed this record on July 24, 2014