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A Phase 1 Study of XL019 in Adults With Polycythemia Vera

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00595829
Recruitment Status : Terminated
First Posted : January 16, 2008
Last Update Posted : August 21, 2015
Information provided by (Responsible Party):

Brief Summary:
The purpose of this study is to evaluate the safety and tolerability of the JAK2 inhibitor XL019 administered orally in adults with Polycythemia Vera.

Condition or disease Intervention/treatment Phase
Polycythemia Vera Drug: XL019 Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3 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 Polycythemia Vera
Study Start Date : December 2007
Actual Primary Completion Date : February 2009
Actual Study Completion Date : February 2009

Arm Intervention/treatment
Experimental: 1 Drug: XL019
XL019 capsules administered orally

Primary Outcome Measures :
  1. Safety and tolerability of XL019 as a single agent when orally administered in adults with Polycythemia Vera (PV) [ Time Frame: Assessed at each visit ]
  2. Determine the maximum tolerated dose (MTD) and dose-limiting toxicities (DLTs) for XL019 [ Time Frame: Assessed at periodic visits ]

Secondary Outcome Measures :
  1. Evaluate pharmacokinetic and pharmacodynamic parameters of XL019 in adults with PV [ Time Frame: Assessed during periodic visits ]
  2. Evaluate preliminary efficacy of XL019 [ Time Frame: Assessed weekly or bi-weekly ]

Information from the National Library of Medicine

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

Inclusion Criteria:

  • The subject has a diagnosis of polycythemia vera (PV), and has failed, or is intolerant of, standard therapies or refuses to take standard medications.
  • 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.
  • Subjects who have received phlebotomy due to PV must have documented phlebotomy history for 12 weeks prior to enrollment.
  • 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 other diagnosis of malignancy or evidence of other malignancey 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 received treatment for PV within 14 days prior to first dose of XL019
  • 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 identifier (NCT number): NCT00595829

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United States, California
UCLA School of Medicine, Center for Health Sciences
Los Angeles, California, United States, 90095
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, Michigan
University of Michigan Health System
Ann Arbor, Michigan, United States, 48109
United States, New York
Weill Cornell Medical College
New York, New York, United States, 10065
Sponsors and Collaborators

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Responsible Party: Exelixis Identifier: NCT00595829     History of Changes
Other Study ID Numbers: XL019-002
First Posted: January 16, 2008    Key Record Dates
Last Update Posted: August 21, 2015
Last Verified: August 2015
Keywords provided by Exelixis:
Polycythemia Vera
Additional relevant MeSH terms:
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Polycythemia Vera
Hematologic Diseases
Bone Marrow Neoplasms
Hematologic Neoplasms
Neoplasms by Site
Bone Marrow Diseases
Myeloproliferative Disorders