A Phase 1 Study of XL019 in Adults With Polycythemia Vera

Stopped early · Phase 1

Conditions studied: Polycythemia Vera

In brief

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

Key facts

Study ID

NCT00595829

Run by

Exelixis

People needed

3

Starts

2007-12-01

Expected to finish

2009-02-01

Last updated by the study team

2015-08-21

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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).

You may not qualify if…

• 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.

Where it is running

• UCLA School of Medicine, Center for Health Sciences — Los Angeles, California, United States
• UCSF - Division of Hematology/Oncology — San Francisco, California, United States
• H. Lee Moffitt Cancer Center & Research Institute — Tampa, Florida, United States
• University of Michigan Health System — Ann Arbor, Michigan, United States
• Weill Cornell Medical College — New York, New York, United States

Full record on ClinicalTrials.gov

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