A Dose-escalation Study of the Safety and Tolerability of Orally Administered TG101348 in Patients With Myelofibrosis
This study has been completed.
Sponsor:
TargeGen
Information provided by:
TargeGen
ClinicalTrials.gov Identifier:
NCT00631462
First received: January 29, 2008
Last updated: October 22, 2009
Last verified: October 2009
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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:
Genetics Home Reference related topics:
essential thrombocythemia
polycythemia vera
primary myelofibrosis
U.S. FDA Resources
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
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 May 19, 2013