Clinical trial NCT00595829: A Phase 1 Study of XL019 in Adults With Polycythemia Vera
Official title: A Phase 1 Dose-Escalation Study of the Safety, Pharmacokinetics, and Pharmacodynamics of XL019 Administered to Subjects With Polycythemia Vera
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Polycythemia Vera
Keywords: Polycythemia Vera
PV
Lead sponsor: Exelixis
Sponsor class: INDUSTRY
First posted: 2008-01-16
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Safety and tolerability of XL019 as a single agent when orally administered in adults with Polycythemia Vera (PV)
timeFrame: Assessed at each visit
measure: Determine the maximum tolerated dose (MTD) and dose-limiting toxicities (DLTs) for XL019
timeFrame: Assessed at periodic visits
Secondary outcomes:
measure: Evaluate pharmacokinetic and pharmacodynamic parameters of XL019 in adults with PV
timeFrame: Assessed during periodic visits
measure: Evaluate preliminary efficacy of XL019
timeFrame: Assessed weekly or bi-weekly
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: UCLA School of Medicine, Center for Health Sciences
state: California
city: San Francisco
country: United States
facility: UCSF - Division of Hematology/Oncology
state: California
city: Tampa
country: United States
facility: H. Lee Moffitt Cancer Center & Research Institute
state: Florida
city: Ann Arbor
country: United States
facility: University of Michigan Health System
state: Michigan
city: New York
country: United States
facility: Weill Cornell Medical College
state: New York
Study officials:
References: