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

Phase 1
18 Years
Not Enrolling
Polycythemia Vera

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Trial Information

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

- 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

- 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

- 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.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Safety and tolerability of XL019 as a single agent when orally administered in adults with Polycythemia Vera (PV)

Outcome Time Frame:

Assessed at each visit

Safety Issue:



United States: Food and Drug Administration

Study ID:




Start Date:

December 2007

Completion Date:

December 2009

Related Keywords:

  • Polycythemia Vera
  • Polycythemia Vera
  • PV
  • Polycythemia
  • Polycythemia Vera



H. Lee Moffitt Cancer Center & Research Institute Tampa, Florida  33612
University of Michigan Health System Ann Arbor, Michigan  
Weill Cornell Medical College New York, New York  10021
UCSF - Division of Hematology/Oncology San Francisco, California  94143
UCLA School of Medicine, Center for Health Sciences Los Angeles, California  90095