ClinicalTrials.gov
 Home    Search    Study Topics    Glossary  
 

  Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
A Safety Study of XL019 in Adults With Myelofibrosis

This study is currently recruiting participants.
Verified by Exelixis, July 2008

Sponsored by: Exelixis
Information provided by: Exelixis
ClinicalTrials.gov Identifier: NCT00522574
  Purpose

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 Intervention Phase
Myeloproliferative Disorders
Myelofibrosis
Polycythemia Vera
Thrombocythemia, Essential
Drug: XL019
Phase I

Genetics Home Reference related topics:   hemophilia   

ChemIDplus related topics:   Gelatin   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study
Official Title:   A Phase 1 Dose-Escalation Study of the Safety, Pharmacokinetics, and Pharmacodynamics of XL019 Administered to Subjects With Myelofibrosis

Further study details as provided by Exelixis:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Determine plasma pharmacokinetics, evaluate pharmacodynamic correlates, and estimate renal elimination of XL019 [ Time Frame: Assessed at periodic visits ] [ Designated as safety issue: No ]
  • Evaluate preliminary efficacy of XL019 as a single agent when administered orally [ Time Frame: Assessed at periodic visits ] [ Designated as safety issue: No ]

Estimated Enrollment:   100
Study Start Date:   August 2007

Intervention Details:
    Drug: XL019
    gelatin capsules supplied in 5-mg, 25-mg, and 100-mg strengths
  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00522574

Contacts
Contact: Roberta Steere, MS, MBA, CCRA     315-858-2040     roberta.steere@bluebell.ppdi.com    

Locations
United States, California
UCSF - Division of Hematology/Oncology     Recruiting
      San Francisco, California, United States, 94143
      Contact: Patrycija Olszynski     415-502-1564     polszynski@medicine.ucsf.edu    
      Principal Investigator: Neil Shah, MD            
United States, Florida
H. Lee Moffitt Cancer Center & Research Institute     Recruiting
      Tampa, Florida, United States, 33612
      Contact: Debra VanDonkelaar     813-745-4626     Debra.VanDonkelaar@moffitt.org    
      Principal Investigator: Lubomir Sokol, MD            
United States, Massachusetts
Dana Farber Cancer Institute     Recruiting
      Boston, Massachusetts, United States, 02115
      Contact: Sara Guterman         sguterman@partners.org    
      Principal Investigator: Martha Wadleigh, MD            
United States, New York
Mt. Sinai School of Medicine     Not yet recruiting
      New York, New York, United States, 10029
      Contact: Amy Rodriguez, RN     212-241-4546     amy.rodriguez@mssm.edu    
      Principal Investigator: Ronald Hoffman, MD            
United States, Texas
MD Anderson Cancer Center     Recruiting
      Houston, Texas, United States, 77030
      Contact: Mary Ann Richie, RN     713-794-5478     mareese@mdanderson.org    
      Principal Investigator: Srdan Verstovsek, MD, PhD            

Sponsors and Collaborators
Exelixis
  More Information


Responsible Party:   Exelixis ( Lynne Bui, MD/Senior Director, Clinical Research )
Study ID Numbers:   XL019-001
First Received:   August 27, 2007
Last Updated:   July 24, 2008
ClinicalTrials.gov Identifier:   NCT00522574
Health Authority:   United States: Food and Drug Administration

Keywords provided by Exelixis:
Myeloproliferative Disorders  

Study placed in the following topic categories:
Polycythemia
Polycythemia Vera
Myelofibrosis
Hematologic Diseases
Blood Coagulation Disorders
Blood Platelet Disorders
Myeloproliferative Disorders
Polycythemia vera
Hemostatic Disorders
Thrombocytopathy
Hemorrhagic Disorders
Thrombocytosis
Thrombocythemia, Hemorrhagic
Bone Marrow Diseases

ClinicalTrials.gov processed this record on October 10, 2008




Links to all studies - primarily for crawlers