A Phase 1 Study of XL019 in Adults With Polycythemia Vera



Status:Terminated
Conditions:Cancer, Hematology
Therapuetic Areas:Hematology, Oncology
Healthy:No
Age Range:18 - Any
Updated:4/21/2016
Start Date:December 2007
End Date:February 2009

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A Phase 1 Dose-Escalation Study of the Safety, Pharmacokinetics, and Pharmacodynamics of XL019 Administered to Subjects With Polycythemia Vera

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


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.
We found this trial at
5
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1500 E Medical Center Dr
Ann Arbor, Michigan 48109
(734) 936-4000
University of Michigan Health System The University of Michigan is home to one of the...
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12902 USF Magnolia Dr
Tampa, Florida 33612
(888) 663-3488
H. Lee Moffitt Cancer Center & Research Institute Moffitt Cancer Center in Tampa, Florida, has...
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New York, New York 10021
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San Francisco, California 94143
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