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A Safety Study of XL019 in Adults With Myelofibrosis

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ClinicalTrials.gov Identifier: NCT00522574
Recruitment Status : Terminated (Due to emerging safety data)
First Posted : August 29, 2007
Last Update Posted : April 5, 2011
Sponsor:
Information provided by:
Exelixis

Brief Summary:
The purpose of this study is to evaluate the safety and tolerability of XL019 in adults with myelofibrosis. XL019 is a selective inhibitor of the cytoplasmic tyrosine kinase JAK2. JAK2 is activated by cytokine and growth factor receptors and phosphorylates members of the STAT family of inducible transcription factors. Activation of the JAK/STAT pathway promotes cell growth and survival, and is a common feature of human tumors. JAK2 is activated by mutation in the majority of patients with myelofibrosis, polycythemia vera and essential thrombocytosis and appears to drive the inappropriate growth of blood cells in these conditions.

Condition or disease Intervention/treatment Phase
Myeloproliferative Disorders Myelofibrosis Polycythemia Vera Thrombocythemia, Essential Drug: XL019 Phase 1

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1 Dose-Escalation Study of the Safety, Pharmacokinetics, and Pharmacodynamics of XL019 Administered to Subjects With Myelofibrosis
Study Start Date : August 2007



Intervention Details:
    Drug: XL019
    gelatin capsules supplied in 5-mg, 25-mg, and 100-mg strengths


Primary Outcome Measures :
  1. To evaluate the safety, tolerability, maximum tolerated dose, and dose-limiting toxicities of XL019 as a single agent when orally administered in subjects with PMF, post-PV MF, or post-ET MF. [ Time Frame: Assessed at periodic visits ]

Secondary Outcome Measures :
  1. Determine plasma pharmacokinetics, evaluate pharmacodynamic correlates, and estimate renal elimination of XL019 [ Time Frame: Assessed at periodic visits ]
  2. Evaluate preliminary efficacy of XL019 as a single agent when administered orally [ Time Frame: Assessed at periodic visits ]


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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:

  • The subject has primary myelofibrosis (PMF), post-polycythemia vera MF, or post-essential thrombocythemia MF and requires therapy, including subjects who have received prior MF-directed therapy and relapsed or subjects with refractory disease; or if newly diagnosed, then with intermediate or high risk according to the Lille scoring system.
  • The subject is unwilling to undergo or is not a candidate for peripheral stem cell/bone marrow transplant.
  • The subject is ≥18 years old.
  • The subject has an Eastern Cooperative Oncology Group (ECOG) performance status of ≤2.
  • The subject has adequate organ function.
  • The subject has the capability of understanding the informed consent document and has signed the informed consent document.
  • Sexually active subjects (male and female) must use medically acceptable methods of contraception during the course of the study.
  • Female subjects of childbearing potential must have a negative pregnancy test at screening.
  • The subject has had no diagnosis of malignancy or evidence of other malignancy for 2 years prior to screening for this study (except non-melanoma skin cancer or in situ carcinoma of the cervix).

Exclusion Criteria:

  • The subject has uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, hypertension, symptomatic congestive heart failure, unstable angina pectoris, myocardial infarction within 3 months, or cardiac arrhythmias.
  • The subject is pregnant or breastfeeding.
  • The subject is known to be positive for the human immunodeficiency virus (HIV).
  • The subject is unable or unwilling to abide by the study protocol or cooperate fully with the investigator or designee.

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): NCT00522574


Locations
United States, California
UCSF - Division of Hematology/Oncology
San Francisco, California, United States, 94143
United States, Florida
H. Lee Moffitt Cancer Center & Research Institute
Tampa, Florida, United States, 33612
United States, Massachusetts
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02115
United States, New York
Mt. Sinai School of Medicine
New York, New York, United States, 10029
United States, Texas
MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
Exelixis

Responsible Party: Chunyan Song, MD/Senior Manager, Clinical Research, Exelixis
ClinicalTrials.gov Identifier: NCT00522574     History of Changes
Other Study ID Numbers: XL019-001
First Posted: August 29, 2007    Key Record Dates
Last Update Posted: April 5, 2011
Last Verified: April 2011

Keywords provided by Exelixis:
Myeloproliferative Disorders

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